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White House declares monkeypox a public health emergency
There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.
“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.
Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.
The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.
Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.
Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.
An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.
The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.
An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.
“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.
The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.
“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.
This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.
“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”
This article was updated 8/4/22.
There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.
“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.
Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.
The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.
Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.
Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.
An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.
The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.
An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.
“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.
The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.
“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.
This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.
“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”
This article was updated 8/4/22.
There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.
“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.
Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.
The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.
Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.
Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.
An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.
The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.
An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.
“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.
The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.
“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.
This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.
“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”
This article was updated 8/4/22.
Single dose of HPV vaccine is ‘game changer,’ says WHO
The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).
From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.
This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.
SAGE recommends updating HPV dose schedules as follows:
- One- or two-dose schedule for the primary target of girls aged 9-14 years.
- One- or two-dose schedule for young women aged 15-20.
- Two doses with a 6-month interval for women older than 21.
The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.
“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.
For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
Policy makers need to make changes
Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.
“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.
Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.
The editorialists also make a radical proposal.
Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).
To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
Two doses in high-income countries
But it is unclear whether high-income countries are ready to move to a one-dose schedule.
Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”
However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.
“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”
Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.
“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.
At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.
Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.
But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.
Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
Trials of one-dose schedules
The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.
The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.
A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.
Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”
Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
Ethics of the vaccine
In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”
It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.
To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”
Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.
Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).
From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.
This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.
SAGE recommends updating HPV dose schedules as follows:
- One- or two-dose schedule for the primary target of girls aged 9-14 years.
- One- or two-dose schedule for young women aged 15-20.
- Two doses with a 6-month interval for women older than 21.
The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.
“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.
For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
Policy makers need to make changes
Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.
“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.
Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.
The editorialists also make a radical proposal.
Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).
To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
Two doses in high-income countries
But it is unclear whether high-income countries are ready to move to a one-dose schedule.
Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”
However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.
“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”
Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.
“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.
At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.
Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.
But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.
Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
Trials of one-dose schedules
The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.
The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.
A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.
Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”
Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
Ethics of the vaccine
In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”
It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.
To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”
Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.
Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).
From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.
This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.
SAGE recommends updating HPV dose schedules as follows:
- One- or two-dose schedule for the primary target of girls aged 9-14 years.
- One- or two-dose schedule for young women aged 15-20.
- Two doses with a 6-month interval for women older than 21.
The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.
“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.
For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
Policy makers need to make changes
Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.
“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.
Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.
The editorialists also make a radical proposal.
Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).
To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
Two doses in high-income countries
But it is unclear whether high-income countries are ready to move to a one-dose schedule.
Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”
However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.
“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”
Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.
“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.
At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.
Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.
But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.
Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
Trials of one-dose schedules
The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.
The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.
A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.
Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”
Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.
“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
Ethics of the vaccine
In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”
It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.
To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”
Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.
Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
LGBTQ+ Youth Consult: Let’s talk about PrEP!
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
As pediatricians, almost all of our clinic visits include some anticipatory guidance and recommendations on ways to promote well-being and prevent illness and injury for our patients. Because of minority stress, discrimination, and increased exposure to adverse childhood experiences, LGBTQ+ patients are disproportionately affected by certain health conditions including depression, anxiety, substance use, homelessness, as well as HIV and other sexually transmitted infections (STIs).1 While LGBTQ+ youth could benefit from additional guidance, counseling, and interventions related to these health disparities and have expressed interest in talking about these topics with their providers, sexual and gender minority youth also stress that they want to be treated as any other youth.2 Extending counseling for preventive care measures such as preexposure prophylaxis (PrEP) for HIV to all sexually active youth could help to destigmatize LGBTQ+ youth as being “different” from other youth and also help to increase overall access to HIV prevention services.3
Described by some as the “birth control” for HIV infection, PrEP is taken on an ongoing basis by those who are HIV negative before potential exposures to HIV in order to prevent new HIV infections. PrEP was first approved as a daily pill for adults in 2015 by the Food and Drug Administration with extension in 2018 to all individuals at risk for HIV weighing at least 35 kg after safety and efficacy data showed it could be used routinely for adolescents.4 When taken daily, oral PrEP can decrease the risk of HIV from sexual contact by more than 90% and from injection drug use by around 70%. As PrEP is highly effective with low risk for side effects, the U.S. Preventive Services Task Force (USPSTF) gave PrEP a “Grade A” recommendation for use in those at high risk for HIV infection in 2019.5 Since efficacy is closely tied to adherence, the first injectable PrEP (given at 0, 1, and 2 months with dosing then every 2 months) was also recently FDA approved in late 2021.6
Since HIV infection disproportionately affects LBGTQ+ individuals, and particularly LBGTQ+ youth of color, counseling related to PrEP has been largely targeted to these groups.7 Insurance and financial barriers to PrEP have been greatly reduced over the past several years through changes in insurance coverage (strengthened by the USPSTF recommendation), supplemental insurance programs, and pharmaceutical copay programs. Many states (but not all) also include HIV in the definition of STIs and allow minors to consent to PrEP services without a parent or guardian. Unfortunately, despite the high efficacy of PrEP and efforts to decrease barriers, rates of PrEP use continue to be extremely low, especially in youth, with only 15.6% of those aged 16-24 who are at risk for HIV in the United States actually taking PrEP in 2019.8 Many barriers to PrEP continue to exist including lack of awareness of PrEP, stigma surrounding HIV and PrEP, and lack of PrEP providers.
In order to address these low rates of PrEP uptake, the Centers for Disease Control and Prevention now recommends that medical providers discuss PrEP with all sexually active patients.6 PrEP should not be seen or discussed as something only relevant to LBGTQ+ populations, but rather as another tool in everyone’s “sexual health toolbox” that can allow us to experience human connection and pleasure through sexual activity while also having more control over what happens to our bodies. Not only will this allow more patients to access PrEP directly, it will also decrease the stigma of talking about HIV and PrEP and strengthen youths’ sense of autonomy and control over their own sexual health.
Since PrEP is a relatively new medical service, many providers will need to learn more about PrEP to at least have initial discussions with patients and to feel comfortable prescribing this themselves (See Resources). Below are also some suggestions to incorporate into your practice in order to advocate for the health and well-being of all your patients, including LGBTQ+ youth.
- Once your patients are 13 years and older, spend time with them alone to confidentially discuss more sensitive topics such as sexual health, mental health, and substance use.
- For all patients who are sexually active or considering sexual activity in the near future, discuss topics to help them control what happens to their bodies including consent, condoms, birth control, PrEP, and routine STI screening.
- Recommend PrEP to anyone who is sexually active and may be at increased risk for HIV infection or who is interested in taking PrEP for HIV prevention.
- Learn more about PrEP and start prescribing it to your own patients or become familiar with providers in your area to whom you could refer patients who are interested. While no certification is needed to prescribe PrEP, programs exist to help providers become more familiar with how to prescribe PrEP.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, HIV prevention for adolescents and young adults, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of clinical pediatrics and a University of Southern California faculty member.
Resources
CDC PrEP resources for clinicians: www.cdc.gov/hiv/clinicians/prevention/prep.html.Health HIV’s HIV Prevention Certified Provider Certification Program: https://healthhiv.org/programs/hpcp/.PrEP providers in the United States: https://preplocator.org/.Adolescent Health Working Group’s Sexual and Reproductive Health Toolkit for Adolescent Providers: https://ahwg.org/download/sexual-and-reproductive-health-toolkit-for-adolescent-providers/.
References
1. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021:48:179-89.
2. Hoffman ND et al. J Adolesc Health. 2009;45:222-9.
3. Mayer KH et al. Adv Ther. 2020;37:1778-811.
4. Hosek SG et al. JAMA Pediatr. 2017;171(11):1063-71.
5. U.S. Preventive Services Task Force; Owens DK et al. JAMA. 2019;321(22):2203-13.
6. Centers for Disease Control and Prevention: U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline. Published 2021. Accessed July 10, 2022.
7. Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2015-2019. HIV Surveillance Supplemental Report. 2021;26(1). Published May 2021. Accessed July 10, 2022.
8. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data–United States and 6 Dependent Areas, 2020. HIV Surveillance Supplemental Report. 2022;27(3).
Provider recommendation key to boosting teen HPV vaccines
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).
The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.
The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.
Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.
In other NIS-Teen findings:
- Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
- Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
- The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
- In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
- Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
- Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
- Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).
Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.
“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.
“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”
According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”
The increased uptake among males was encouraging, said Ms. Thew.
Sharing her perspective on the survey-based study but not involved in it, Melissa B. Gilkey, PhD, associate professor of health behavior at the University of North Carolina in Chapel Hill, said the study is important for characterizing national trends in HPV vaccination coverage using high-quality data. “The almost 20-percentage-point jump in HPV vaccination coverage from 2015 to 2020 speaks to the hard work of primary care doctors and nurses, health departments, the CDC, and other government agencies, and public health researchers,” she told this news organization. “We’ve long understood how critical primary care is, but these data are a powerful reminder that if we want to increase HPV vaccination rates, we need to be supporting primary care doctors and nurses.”
Dr. Gilkey added that effective interventions are available to help primary care teams recommend the HPV vaccine and address parents’ vaccination concerns effectively. “However, there remains an urgent need to roll out these interventions nationally.”
This is especially true in the context of the COVID-19 pandemic, which has disrupted well-child visits and led to a decline in HPV vaccination coverage, she said. “We can’t afford to lose our hard-won gains in HPV vaccination coverage, so supporting provider recommendations and well-child visits is more important now than ever.”
According to Dr. Lu, providers should routinely recommend the vaccine and highlight the importance of vaccination in preventing HPV-related cancers. “Additionally, health care providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives HPV vaccine and other needed vaccines.”
This study had no external funding. The authors had no potential conflicts of interest to disclose. Dr. Gilkey is co-principal investigator of a CDC-funded study evaluating a model for improving HPV vaccine coverage in primary care settings. Ms. Thew disclosed no potential conflicts of interest.
FROM PEDIATRICS
Is hepatitis C an STI?
A 32-year-old woman had sex with a man she met while on vacation 6 weeks ago. She was intoxicated at the time and does not know much about the person. She recalls having engaged in vaginal intercourse without a condom. She does not have any symptoms.
She previously received baseline lab testing per Centers for Disease Control and Prevention guidelines 2 years ago with a negative HIV test and negative hepatitis C test. She asks for testing for STIs. What would you recommend?
A. HIV, hepatitis C, gonorrhea, chlamydia, and human papillomavirus
B. HIV, hepatitis C, gonorrhea, chlamydia, and herpes simplex virus
C. HIV, hepatitis C, gonorrhea, and chlamydia
D. HIV, gonorrhea, and chlamydia
E. Gonorrhea and chlamydia
HIV risk estimate
The most practical answer is E, check for gonorrhea and chlamydia. Many protocols in place for evaluating people for STIs will test for hepatitis C as well as HIV with single exposures. In this column, we will look at the lack of evidence of heterosexual sexual transmission of hepatitis C.
In regards to HIV risk, the estimated risk of transmission male to female from an HIV-infected individual is 0.08% per sexual encounter.1 The prevalence in the United States – where HIV occurs in about 0.5% of the adult population – was used to estimate the risk of a person with unknown HIV status acquiring HIV. The calculated risk from one sexual encounter would be 0.0004 (1 in 250,000).
Studies of hepatitis C transmission
Tahan and colleagues did a prospective study of 600 heterosexual couples where one partner had hepatitis C and the other didn’t. Over a mean of 3 years of follow-up, none of the seronegative spouses developed hepatitis C.2
Terrault and colleagues completed a cross-sectional study of hepatitis C virus (HCV)–positive individuals and their monogamous heterosexual partners to evaluate risk of sexual transmission of HCV.3 Based on 8,377 person-years of follow-up, the estimated maximum transmission rate was 0.07%/year, which was about 1/190,000 sexual contacts. No specific sexual practices were associated with transmission. The authors of this study concurred with CDC recommendations that persons with HCV infection in long-term monogamous relationships need not change their sexual practices.4
Vandelli and colleagues followed 776 heterosexual partners of HCV-infected individuals over 10 years.5 None of the couples reported condom use. Over the follow up period, three HCV infections occurred, but based on discordance of the typing of viral isolates, sexual transmission was excluded.
Jin and colleagues completed a systematic review of studies looking at possible sexual transmission of HCV in gay and bisexual men.6 HIV-positive men had a HCV incidence of 6.4 per 1,000 person-years, compared with 0.4 per 1000 person-years in HIV-negative men. The authors discussed several possible causes for increased transmission risk in HIV-infected individuals including coexisting STIs and higher HCV viral load in semen of HIV-infected individuals, as well as lower immunity.
Summary
In hepatitis C–discordant heterosexual couples, hepatitis C does not appear to be sexually transmitted.
The risk of sexual transmission of hepatitis C to non–HIV-infected individuals appears to be exceedingly low.
Many thanks to Hunter Handsfield, MD, for suggesting this topic and sharing supporting articles.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
1. Boily MC et al. Lancet Infect Dis. 2009 Feb;9(2):118-29.
2. Tahan V et al. Am J Gastroenterol. 2005;100:821-4.
3. Terrault NA et al. Hepatology. 2013;57:881-9
4. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-38.
5. Vandelli C et al. Am J Gastroenterol. 2004;99:855-9.
6. Jin F et al. Sexual Health.2017;14:28-41.
A 32-year-old woman had sex with a man she met while on vacation 6 weeks ago. She was intoxicated at the time and does not know much about the person. She recalls having engaged in vaginal intercourse without a condom. She does not have any symptoms.
She previously received baseline lab testing per Centers for Disease Control and Prevention guidelines 2 years ago with a negative HIV test and negative hepatitis C test. She asks for testing for STIs. What would you recommend?
A. HIV, hepatitis C, gonorrhea, chlamydia, and human papillomavirus
B. HIV, hepatitis C, gonorrhea, chlamydia, and herpes simplex virus
C. HIV, hepatitis C, gonorrhea, and chlamydia
D. HIV, gonorrhea, and chlamydia
E. Gonorrhea and chlamydia
HIV risk estimate
The most practical answer is E, check for gonorrhea and chlamydia. Many protocols in place for evaluating people for STIs will test for hepatitis C as well as HIV with single exposures. In this column, we will look at the lack of evidence of heterosexual sexual transmission of hepatitis C.
In regards to HIV risk, the estimated risk of transmission male to female from an HIV-infected individual is 0.08% per sexual encounter.1 The prevalence in the United States – where HIV occurs in about 0.5% of the adult population – was used to estimate the risk of a person with unknown HIV status acquiring HIV. The calculated risk from one sexual encounter would be 0.0004 (1 in 250,000).
Studies of hepatitis C transmission
Tahan and colleagues did a prospective study of 600 heterosexual couples where one partner had hepatitis C and the other didn’t. Over a mean of 3 years of follow-up, none of the seronegative spouses developed hepatitis C.2
Terrault and colleagues completed a cross-sectional study of hepatitis C virus (HCV)–positive individuals and their monogamous heterosexual partners to evaluate risk of sexual transmission of HCV.3 Based on 8,377 person-years of follow-up, the estimated maximum transmission rate was 0.07%/year, which was about 1/190,000 sexual contacts. No specific sexual practices were associated with transmission. The authors of this study concurred with CDC recommendations that persons with HCV infection in long-term monogamous relationships need not change their sexual practices.4
Vandelli and colleagues followed 776 heterosexual partners of HCV-infected individuals over 10 years.5 None of the couples reported condom use. Over the follow up period, three HCV infections occurred, but based on discordance of the typing of viral isolates, sexual transmission was excluded.
Jin and colleagues completed a systematic review of studies looking at possible sexual transmission of HCV in gay and bisexual men.6 HIV-positive men had a HCV incidence of 6.4 per 1,000 person-years, compared with 0.4 per 1000 person-years in HIV-negative men. The authors discussed several possible causes for increased transmission risk in HIV-infected individuals including coexisting STIs and higher HCV viral load in semen of HIV-infected individuals, as well as lower immunity.
Summary
In hepatitis C–discordant heterosexual couples, hepatitis C does not appear to be sexually transmitted.
The risk of sexual transmission of hepatitis C to non–HIV-infected individuals appears to be exceedingly low.
Many thanks to Hunter Handsfield, MD, for suggesting this topic and sharing supporting articles.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
1. Boily MC et al. Lancet Infect Dis. 2009 Feb;9(2):118-29.
2. Tahan V et al. Am J Gastroenterol. 2005;100:821-4.
3. Terrault NA et al. Hepatology. 2013;57:881-9
4. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-38.
5. Vandelli C et al. Am J Gastroenterol. 2004;99:855-9.
6. Jin F et al. Sexual Health.2017;14:28-41.
A 32-year-old woman had sex with a man she met while on vacation 6 weeks ago. She was intoxicated at the time and does not know much about the person. She recalls having engaged in vaginal intercourse without a condom. She does not have any symptoms.
She previously received baseline lab testing per Centers for Disease Control and Prevention guidelines 2 years ago with a negative HIV test and negative hepatitis C test. She asks for testing for STIs. What would you recommend?
A. HIV, hepatitis C, gonorrhea, chlamydia, and human papillomavirus
B. HIV, hepatitis C, gonorrhea, chlamydia, and herpes simplex virus
C. HIV, hepatitis C, gonorrhea, and chlamydia
D. HIV, gonorrhea, and chlamydia
E. Gonorrhea and chlamydia
HIV risk estimate
The most practical answer is E, check for gonorrhea and chlamydia. Many protocols in place for evaluating people for STIs will test for hepatitis C as well as HIV with single exposures. In this column, we will look at the lack of evidence of heterosexual sexual transmission of hepatitis C.
In regards to HIV risk, the estimated risk of transmission male to female from an HIV-infected individual is 0.08% per sexual encounter.1 The prevalence in the United States – where HIV occurs in about 0.5% of the adult population – was used to estimate the risk of a person with unknown HIV status acquiring HIV. The calculated risk from one sexual encounter would be 0.0004 (1 in 250,000).
Studies of hepatitis C transmission
Tahan and colleagues did a prospective study of 600 heterosexual couples where one partner had hepatitis C and the other didn’t. Over a mean of 3 years of follow-up, none of the seronegative spouses developed hepatitis C.2
Terrault and colleagues completed a cross-sectional study of hepatitis C virus (HCV)–positive individuals and their monogamous heterosexual partners to evaluate risk of sexual transmission of HCV.3 Based on 8,377 person-years of follow-up, the estimated maximum transmission rate was 0.07%/year, which was about 1/190,000 sexual contacts. No specific sexual practices were associated with transmission. The authors of this study concurred with CDC recommendations that persons with HCV infection in long-term monogamous relationships need not change their sexual practices.4
Vandelli and colleagues followed 776 heterosexual partners of HCV-infected individuals over 10 years.5 None of the couples reported condom use. Over the follow up period, three HCV infections occurred, but based on discordance of the typing of viral isolates, sexual transmission was excluded.
Jin and colleagues completed a systematic review of studies looking at possible sexual transmission of HCV in gay and bisexual men.6 HIV-positive men had a HCV incidence of 6.4 per 1,000 person-years, compared with 0.4 per 1000 person-years in HIV-negative men. The authors discussed several possible causes for increased transmission risk in HIV-infected individuals including coexisting STIs and higher HCV viral load in semen of HIV-infected individuals, as well as lower immunity.
Summary
In hepatitis C–discordant heterosexual couples, hepatitis C does not appear to be sexually transmitted.
The risk of sexual transmission of hepatitis C to non–HIV-infected individuals appears to be exceedingly low.
Many thanks to Hunter Handsfield, MD, for suggesting this topic and sharing supporting articles.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.
1. Boily MC et al. Lancet Infect Dis. 2009 Feb;9(2):118-29.
2. Tahan V et al. Am J Gastroenterol. 2005;100:821-4.
3. Terrault NA et al. Hepatology. 2013;57:881-9
4. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47:1-38.
5. Vandelli C et al. Am J Gastroenterol. 2004;99:855-9.
6. Jin F et al. Sexual Health.2017;14:28-41.
Doxycycline bests azithromycin for anorectal chlamydia in women
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
Imiquimod cream offers alternative to surgery for vulvar lesions
Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.
The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.
“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.
The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.
The study was published online in The Lancet.
The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
First head-to-head trial
For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.
The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.
Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.
The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.
Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.
“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.
Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.
They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.
“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.
The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.
The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.
“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.
The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.
The study was published online in The Lancet.
The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
First head-to-head trial
For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.
The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.
Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.
The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.
Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.
“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.
Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.
They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.
“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.
The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.
The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.
“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.
The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.
The study was published online in The Lancet.
The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
First head-to-head trial
For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.
The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.
Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.
The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.
Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.
“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.
Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.
They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.
“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.
The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most at-home STI testing kits fail to meet young people’s needs
The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.
While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”
The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).
According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”
The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.
The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”
Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.
Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.
Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.
As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.
Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.
The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.
Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.
At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.
“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.
In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.
Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”
The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.
While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”
The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).
According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”
The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.
The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”
Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.
Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.
Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.
As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.
Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.
The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.
Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.
At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.
“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.
In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.
Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”
The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.
While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”
The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).
According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”
The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.
The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”
Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.
Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.
Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.
As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.
Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.
The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.
Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.
At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.
“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.
In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.
Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”
FROM ACOG 2022
Sexually transmitted infections on a 30-year rise worldwide
The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.
“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”
“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
STIs are a major worldwide public health challenge
To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.
They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.
Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.
- Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
- The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
- Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
- The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
- The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).
The authors deliver a call to action
“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”
“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.
“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”
Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.
“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.
“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”
Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.
The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.
The World Health Organization aims to end the STI epidemic by 2030, they note.
The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.
“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”
“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
STIs are a major worldwide public health challenge
To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.
They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.
Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.
- Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
- The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
- Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
- The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
- The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).
The authors deliver a call to action
“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”
“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.
“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”
Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.
“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.
“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”
Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.
The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.
The World Health Organization aims to end the STI epidemic by 2030, they note.
The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.
“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”
“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
STIs are a major worldwide public health challenge
To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.
They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.
Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.
- Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
- The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
- Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
- The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
- The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).
The authors deliver a call to action
“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”
“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.
“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”
Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.
“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.
“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”
Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.
The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.
The World Health Organization aims to end the STI epidemic by 2030, they note.
The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET INFECTIOUS DISEASES
Babies die as congenital syphilis continues a decade-long surge across the U.S.
For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.
In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.
About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.
For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.
“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”
Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.
The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.
From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.
Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.
The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.
In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.
In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.
Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.
Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.
Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.
Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.
But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.
After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.
Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.
And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.
Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.
By 2020, New Mexico had the highest rate of congenital syphilis in the country.
The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.
As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.
The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.
The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.
Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.
“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation
For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.
In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.
About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.
For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.
“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”
Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.
The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.
From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.
Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.
The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.
In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.
In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.
Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.
Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.
Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.
Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.
But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.
After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.
Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.
And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.
Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.
By 2020, New Mexico had the highest rate of congenital syphilis in the country.
The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.
As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.
The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.
The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.
Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.
“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation
For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.
In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.
About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.
For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.
“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”
Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.
The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.
From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.
Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.
The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.
In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.
In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.
Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.
Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.
Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.
Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.
But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.
After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.
Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.
And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.
Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.
By 2020, New Mexico had the highest rate of congenital syphilis in the country.
The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.
As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.
The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.
The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.
Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.
“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation