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New Cause of Sexually Transmitted Fungal Infection Reported in MSM

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Thu, 11/14/2024 - 15:04

A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.

 

Dr. Avrom S. Caplan

“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.

“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.

The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.

All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.

Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.

Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.” 

Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.

“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.” 

 

Encourage Reporting and Identify New Infections

“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.

“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.

In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.” 

Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.

The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”

“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.

Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.” 

Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.

The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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Wed, 11/13/2024 - 13:02

Home HPV Testing: A New Frontier in Primary Care

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Tue, 10/22/2024 - 16:34

Human papillomavirus (HPV) is one of the most common sexually transmitted infections and persistent infection with high-risk strains is the leading cause of cervical cancer. Fortunately, vaccines are available to prevent many HPV-related diseases, but they haven’t fully eliminated the risks. Cervical cancer screening remains essential for early detection and prevention.

The US Preventive Services Task Force (USPSTF) currently recommends regular cervical cancer screenings for women aged 21-65. These screenings can include a Pap test every 3 years, a combination of HPV testing and Pap smear every 5 years, or high-risk HPV testing alone every 5 years, depending on age and individual risk factors.

Dr. Santina J.G. Wheat

Although these guidelines are currently under review, routine screenings have been instrumental in reducing cervical cancer rates. However, many patients still face barriers that prevent them from accessing these services. Common challenges include discomfort with pelvic exams, lack of time, and limited access to healthcare services. In recent years, advancements in home-based diagnostic testing have opened new avenues for preventative care.

Home HPV testing is one such advancement, offering an alternative to traditional in-office screening methods. While the US Food and Drug Administration (FDA) has not yet approved home HPV testing, self-collection in clinical settings is available and gaining traction. Primary care physicians can integrate this self-collection method into their practices, helping to close the screening gap, especially for underserved populations.

If approved, home HPV testing could be a game-changer for patients who have difficulty attending in-person visits. Geographical barriers, transportation issues, and personal discomfort with in-office exams can prevent patients from receiving the care they need. Home testing eliminates many of these hurdles, enabling patients to perform the test in the comfort of their own homes at a time that works for them. This flexibility is particularly beneficial for rural and underserved populations, where access to healthcare is limited.

Similarly, in-office self-collection offers a comfortable alternative for those who find traditional pelvic exams uncomfortable or distressing. Self-administered HPV tests allow patients to take control of their cervical cancer screening, fostering empowerment and personal responsibility for their health. By reducing the discomfort and inconvenience of traditional screening, self-collection can improve adherence to screening guidelines, leading to earlier detection and prevention of cervical cancer.

Primary care physicians may soon offer both in-office and at-home testing options, tailoring the approach to each patient’s unique needs. Virtual appointments provide an excellent opportunity to educate patients about the importance of cervical cancer screening and offer guidance on using home HPV testing kits. This personalized care ensures patients feel supported even without in-person visits. If home testing becomes FDA approved, patients could receive test kits by mail, perform the test, and send it back to the lab for analysis. For those with positive results, primary care physicians can ensure timely follow-up, including Pap smears or colposcopies, to further evaluate cervical health.

Although home HPV testing offers many benefits, there are valid concerns about accuracy and follow-up care. Studies show that self-collected samples for HPV testing are highly accurate, with sensitivity and specificity comparable with clinician-collected samples, echoing the success of self-swabbing for other sexually transmitted infections.

It is crucial, however, that patients receive clear instructions on proper sample collection to maintain this accuracy. Follow-up care is another essential aspect of the screening process. While many HPV infections resolve on their own, high-risk strains require closer monitoring to prevent progression to cervical cancer. Primary care physicians must establish clear protocols for notifying patients of their results and ensuring appropriate follow-up appointments.

Additionally, there may be concerns about the cost and insurance coverage of home HPV tests. However, home testing could prove more cost-effective than multiple in-office visits, especially when factoring in travel expenses and missed work. Physicians should work to make home testing accessible to all patients, including those in low-income and rural communities.

Should these options become more widely available, it will be important to communicate that this does not fully eliminate the need for pelvic exams. As primary care physicians, we will still need to advise patients that they should bring up concerns of vaginal bleeding, vaginal discharge, and other symptoms. Pelvic exams will still be necessary for diagnosis when symptoms are present. Home HPV tests also will not replace in-office clinician collected exams for those who do not feel comfortable with self-collection.

Home and in-office self-collection for HPV testing are promising tools for improving cervical cancer screening rates and patient satisfaction. By offering a convenient, private, and accessible option, primary care physicians can help more patients stay on track with their preventive care and reduce their risk of cervical cancer. As this technology continues to evolve, embracing both in-office and home HPV testing will be essential to ensuring all patients benefit from these innovations.
 

Dr. Wheat is Vice Chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine and Associate Professor, Family and Community Medicine Feinberg School of Medicine, Northwestern University, Chicago. She serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

Daponte N et al. HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature. Cancers (Basel). 2023 Mar 8;15(6):1669.

Di Gennaro G et al. Does self-sampling for human papilloma virus testing have the potential to increase cervical cancer screening? An updated meta-analysis of observational studies and randomized clinical trials. Front Public Health. 2022 Dec 8;10:1003461.

US Preventive Services Task Force. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;320(7):674-686.

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Human papillomavirus (HPV) is one of the most common sexually transmitted infections and persistent infection with high-risk strains is the leading cause of cervical cancer. Fortunately, vaccines are available to prevent many HPV-related diseases, but they haven’t fully eliminated the risks. Cervical cancer screening remains essential for early detection and prevention.

The US Preventive Services Task Force (USPSTF) currently recommends regular cervical cancer screenings for women aged 21-65. These screenings can include a Pap test every 3 years, a combination of HPV testing and Pap smear every 5 years, or high-risk HPV testing alone every 5 years, depending on age and individual risk factors.

Dr. Santina J.G. Wheat

Although these guidelines are currently under review, routine screenings have been instrumental in reducing cervical cancer rates. However, many patients still face barriers that prevent them from accessing these services. Common challenges include discomfort with pelvic exams, lack of time, and limited access to healthcare services. In recent years, advancements in home-based diagnostic testing have opened new avenues for preventative care.

Home HPV testing is one such advancement, offering an alternative to traditional in-office screening methods. While the US Food and Drug Administration (FDA) has not yet approved home HPV testing, self-collection in clinical settings is available and gaining traction. Primary care physicians can integrate this self-collection method into their practices, helping to close the screening gap, especially for underserved populations.

If approved, home HPV testing could be a game-changer for patients who have difficulty attending in-person visits. Geographical barriers, transportation issues, and personal discomfort with in-office exams can prevent patients from receiving the care they need. Home testing eliminates many of these hurdles, enabling patients to perform the test in the comfort of their own homes at a time that works for them. This flexibility is particularly beneficial for rural and underserved populations, where access to healthcare is limited.

Similarly, in-office self-collection offers a comfortable alternative for those who find traditional pelvic exams uncomfortable or distressing. Self-administered HPV tests allow patients to take control of their cervical cancer screening, fostering empowerment and personal responsibility for their health. By reducing the discomfort and inconvenience of traditional screening, self-collection can improve adherence to screening guidelines, leading to earlier detection and prevention of cervical cancer.

Primary care physicians may soon offer both in-office and at-home testing options, tailoring the approach to each patient’s unique needs. Virtual appointments provide an excellent opportunity to educate patients about the importance of cervical cancer screening and offer guidance on using home HPV testing kits. This personalized care ensures patients feel supported even without in-person visits. If home testing becomes FDA approved, patients could receive test kits by mail, perform the test, and send it back to the lab for analysis. For those with positive results, primary care physicians can ensure timely follow-up, including Pap smears or colposcopies, to further evaluate cervical health.

Although home HPV testing offers many benefits, there are valid concerns about accuracy and follow-up care. Studies show that self-collected samples for HPV testing are highly accurate, with sensitivity and specificity comparable with clinician-collected samples, echoing the success of self-swabbing for other sexually transmitted infections.

It is crucial, however, that patients receive clear instructions on proper sample collection to maintain this accuracy. Follow-up care is another essential aspect of the screening process. While many HPV infections resolve on their own, high-risk strains require closer monitoring to prevent progression to cervical cancer. Primary care physicians must establish clear protocols for notifying patients of their results and ensuring appropriate follow-up appointments.

Additionally, there may be concerns about the cost and insurance coverage of home HPV tests. However, home testing could prove more cost-effective than multiple in-office visits, especially when factoring in travel expenses and missed work. Physicians should work to make home testing accessible to all patients, including those in low-income and rural communities.

Should these options become more widely available, it will be important to communicate that this does not fully eliminate the need for pelvic exams. As primary care physicians, we will still need to advise patients that they should bring up concerns of vaginal bleeding, vaginal discharge, and other symptoms. Pelvic exams will still be necessary for diagnosis when symptoms are present. Home HPV tests also will not replace in-office clinician collected exams for those who do not feel comfortable with self-collection.

Home and in-office self-collection for HPV testing are promising tools for improving cervical cancer screening rates and patient satisfaction. By offering a convenient, private, and accessible option, primary care physicians can help more patients stay on track with their preventive care and reduce their risk of cervical cancer. As this technology continues to evolve, embracing both in-office and home HPV testing will be essential to ensuring all patients benefit from these innovations.
 

Dr. Wheat is Vice Chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine and Associate Professor, Family and Community Medicine Feinberg School of Medicine, Northwestern University, Chicago. She serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

Daponte N et al. HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature. Cancers (Basel). 2023 Mar 8;15(6):1669.

Di Gennaro G et al. Does self-sampling for human papilloma virus testing have the potential to increase cervical cancer screening? An updated meta-analysis of observational studies and randomized clinical trials. Front Public Health. 2022 Dec 8;10:1003461.

US Preventive Services Task Force. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;320(7):674-686.

Human papillomavirus (HPV) is one of the most common sexually transmitted infections and persistent infection with high-risk strains is the leading cause of cervical cancer. Fortunately, vaccines are available to prevent many HPV-related diseases, but they haven’t fully eliminated the risks. Cervical cancer screening remains essential for early detection and prevention.

The US Preventive Services Task Force (USPSTF) currently recommends regular cervical cancer screenings for women aged 21-65. These screenings can include a Pap test every 3 years, a combination of HPV testing and Pap smear every 5 years, or high-risk HPV testing alone every 5 years, depending on age and individual risk factors.

Dr. Santina J.G. Wheat

Although these guidelines are currently under review, routine screenings have been instrumental in reducing cervical cancer rates. However, many patients still face barriers that prevent them from accessing these services. Common challenges include discomfort with pelvic exams, lack of time, and limited access to healthcare services. In recent years, advancements in home-based diagnostic testing have opened new avenues for preventative care.

Home HPV testing is one such advancement, offering an alternative to traditional in-office screening methods. While the US Food and Drug Administration (FDA) has not yet approved home HPV testing, self-collection in clinical settings is available and gaining traction. Primary care physicians can integrate this self-collection method into their practices, helping to close the screening gap, especially for underserved populations.

If approved, home HPV testing could be a game-changer for patients who have difficulty attending in-person visits. Geographical barriers, transportation issues, and personal discomfort with in-office exams can prevent patients from receiving the care they need. Home testing eliminates many of these hurdles, enabling patients to perform the test in the comfort of their own homes at a time that works for them. This flexibility is particularly beneficial for rural and underserved populations, where access to healthcare is limited.

Similarly, in-office self-collection offers a comfortable alternative for those who find traditional pelvic exams uncomfortable or distressing. Self-administered HPV tests allow patients to take control of their cervical cancer screening, fostering empowerment and personal responsibility for their health. By reducing the discomfort and inconvenience of traditional screening, self-collection can improve adherence to screening guidelines, leading to earlier detection and prevention of cervical cancer.

Primary care physicians may soon offer both in-office and at-home testing options, tailoring the approach to each patient’s unique needs. Virtual appointments provide an excellent opportunity to educate patients about the importance of cervical cancer screening and offer guidance on using home HPV testing kits. This personalized care ensures patients feel supported even without in-person visits. If home testing becomes FDA approved, patients could receive test kits by mail, perform the test, and send it back to the lab for analysis. For those with positive results, primary care physicians can ensure timely follow-up, including Pap smears or colposcopies, to further evaluate cervical health.

Although home HPV testing offers many benefits, there are valid concerns about accuracy and follow-up care. Studies show that self-collected samples for HPV testing are highly accurate, with sensitivity and specificity comparable with clinician-collected samples, echoing the success of self-swabbing for other sexually transmitted infections.

It is crucial, however, that patients receive clear instructions on proper sample collection to maintain this accuracy. Follow-up care is another essential aspect of the screening process. While many HPV infections resolve on their own, high-risk strains require closer monitoring to prevent progression to cervical cancer. Primary care physicians must establish clear protocols for notifying patients of their results and ensuring appropriate follow-up appointments.

Additionally, there may be concerns about the cost and insurance coverage of home HPV tests. However, home testing could prove more cost-effective than multiple in-office visits, especially when factoring in travel expenses and missed work. Physicians should work to make home testing accessible to all patients, including those in low-income and rural communities.

Should these options become more widely available, it will be important to communicate that this does not fully eliminate the need for pelvic exams. As primary care physicians, we will still need to advise patients that they should bring up concerns of vaginal bleeding, vaginal discharge, and other symptoms. Pelvic exams will still be necessary for diagnosis when symptoms are present. Home HPV tests also will not replace in-office clinician collected exams for those who do not feel comfortable with self-collection.

Home and in-office self-collection for HPV testing are promising tools for improving cervical cancer screening rates and patient satisfaction. By offering a convenient, private, and accessible option, primary care physicians can help more patients stay on track with their preventive care and reduce their risk of cervical cancer. As this technology continues to evolve, embracing both in-office and home HPV testing will be essential to ensuring all patients benefit from these innovations.
 

Dr. Wheat is Vice Chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine and Associate Professor, Family and Community Medicine Feinberg School of Medicine, Northwestern University, Chicago. She serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

Daponte N et al. HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature. Cancers (Basel). 2023 Mar 8;15(6):1669.

Di Gennaro G et al. Does self-sampling for human papilloma virus testing have the potential to increase cervical cancer screening? An updated meta-analysis of observational studies and randomized clinical trials. Front Public Health. 2022 Dec 8;10:1003461.

US Preventive Services Task Force. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;320(7):674-686.

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Sex After Pregnancy: Why It Matters and How to Start the Conversation

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Sarah, a new mom who’s thrilled about her 3-month-old baby, is struggling with her sex life. Her once vibrant physical relationship with her partner has dwindled, and she’s dealing with painful intercourse and a notable drop in desire.

Pregnancy and childbirth are transformative experiences that affect every facet of a person’s life, including their sexual well-being. Despite this fact, clinicians frequently ignore sexual well-being, beyond contraception, in prenatal and postpartum care. In peripartum care, anticipatory guidance is recognized to be crucial to the well-being of new parents and their babies. Why should sexual well-being get the shaft? 
 

Why Talk About Sex?

Sex is a fundamental aspect of many people’s lives and relationships and can significantly affect overall well-being. Despite cultural narratives that often exclude the sexual function and pleasure aspect of sexual health from peripartum discussions, many new parents face sexual challenges that can worsen their physical and emotional health.

While up to 88% of new parents report problems with sexual well-being, less than 30% report receiving anticipatory guidance about sexual function changes. One study found only 15% of postpartum women reported discussing sexual concerns with their medical providers. And, when new parents receive more information about sexual health, they tend to report improved sexual well-being. Clearly, a gap needs bridging.

Sexual health doesn’t just affect individual well-being; it intertwines with relationship satisfaction. Attending to satisfaction in one’s relationship may be an important component of child health as well. 

Declines in the frequency of sexual engagement and desire are common after childbirth. Changes in arousal, orgasm, and sexual pleasure, often accompanied by pain, are also reported by many women. Some birthing parents report changes to the sensation of their genitals that are thought to be related to stretch of the pudendal nerve during parturition. Most experience resolution of these concerns within the first year after childbirth, although some women report persistent problems, including up to 33% with persistent sexual pain.

Many factors can contribute to postpartum sexual issues, including hormonal changes, body image concerns, and mental health conditions. Breastfeeding, for instance, can lead to vaginal dryness and reduced sexual arousal due to hormonal shifts. Body image issues and mood disorders like depression and anxiety can also adversely affect sexual function. Women with postpartum depression are more likely to experience sexual concerns, and the relationship between sexual difficulties and depression can be bidirectional.
 

Empowerment and Expectations

One commonly cited recommendation is to wait until 6 weeks postpartum before resuming penetrative intercourse after a normal vaginal delivery. However, this guideline lacks robust scientific backing. Many people might feel ready for sexual intercourse much sooner or, conversely, might not feel comfortable at the 6-week mark. As clinicians, we must empower our patients to trust their own bodies and make decisions based on their comfort and readiness.

The 6-week advice can sometimes unintentionally convey to women that they are not experts on their own bodies, or that any kind of sex is risky. Acknowledging the recovery timeline for every person is unique and various forms of sexual expression are safe can help foster a healthier approach to resuming sexual activities. In one study of postpartum sexual behavior, in the first 6 weeks after delivery, the most common kinds of sexual play included giving oral sex to a partner and solo sex. Between 80% and 90% have resumed vaginal-receiving sexual play (including intercourse) by 3 months. 

While recognizing that changes to sexual experience occur, we need to reinforce that gradual recovery is expected. And if women express distress about a sexual change, or if those changes persist, primary care providers should be prepared to help them with their concerns. 

Parents need to know experiencing pain is not something they should “just deal with” or ignore. Attempting to repeatedly endure sexual pain can cause new issues, such as high-tone dysfunction of the pelvic floor or an understandable decrease in willingness or receptiveness to sexual play of any kind. Encouraging open communication about these issues can help couples navigate these changes more smoothly.

Partners, especially new fathers, also experience sexual and emotional challenges. They can feel blindsided by the changes in their relationship and might struggle with feelings of jealousy or inadequacy. Understanding partners also face difficulties can help in providing a more comprehensive approach to sexual health care.
 

 

 

Starting the Conversation

So, how can we initiate these important conversations with new parents? Start by providing permission. As healthcare providers, we need to create an environment where discussing sexual health is normalized and welcomed. Simple, nonjudgmental statements can open the door to these discussions. For example, saying, “Many people notice changes in their sexual desire or pleasure after childbirth. Has anything like this happened to you or your partner?” can encourage patients to share their concerns.

Assessing the importance to patients of sexual problems can help direct the need for intervention. Follow up on these concerns and offer support, whether through counseling, pelvic floor physical therapy, or a referral to a sexual medicine specialist, a sex therapist, or other appropriate resource.

Let’s return to Sarah. In the ideal world, at 3 months postpartum she will already have had a handful of clinical conversations about her sexual well-being with her healthcare team — at prenatal visits, at well-baby visits, and at her postpartum checkups. Several of these conversations included her partner. They both understand the transition to parenthood could be rocky for their sex lives. They’ve set aside time to connect and stay physically close. She’s listened to her body and only engaged in sexual play for which she feels ready. Now, noting that some aspects of sexual play are persistently uncomfortable, she knows it’s time to follow up. Without shame or anxiety, she books an appointment with you, knowing that you understand how important this issue is for her, her partner, and her baby. 

If you’re working with new parents, remember: Open dialogue about sexual health is not just beneficial — it’s essential. Let’s bridge the gap in care by embracing these conversations and offering the support new parents truly need.
 

Dr. Kranz, Clinical Assistant Professor of Obstetrics/Gynecology and Family Medicine, University of Rochester Medical Center, Rochester, New York, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Sarah, a new mom who’s thrilled about her 3-month-old baby, is struggling with her sex life. Her once vibrant physical relationship with her partner has dwindled, and she’s dealing with painful intercourse and a notable drop in desire.

Pregnancy and childbirth are transformative experiences that affect every facet of a person’s life, including their sexual well-being. Despite this fact, clinicians frequently ignore sexual well-being, beyond contraception, in prenatal and postpartum care. In peripartum care, anticipatory guidance is recognized to be crucial to the well-being of new parents and their babies. Why should sexual well-being get the shaft? 
 

Why Talk About Sex?

Sex is a fundamental aspect of many people’s lives and relationships and can significantly affect overall well-being. Despite cultural narratives that often exclude the sexual function and pleasure aspect of sexual health from peripartum discussions, many new parents face sexual challenges that can worsen their physical and emotional health.

While up to 88% of new parents report problems with sexual well-being, less than 30% report receiving anticipatory guidance about sexual function changes. One study found only 15% of postpartum women reported discussing sexual concerns with their medical providers. And, when new parents receive more information about sexual health, they tend to report improved sexual well-being. Clearly, a gap needs bridging.

Sexual health doesn’t just affect individual well-being; it intertwines with relationship satisfaction. Attending to satisfaction in one’s relationship may be an important component of child health as well. 

Declines in the frequency of sexual engagement and desire are common after childbirth. Changes in arousal, orgasm, and sexual pleasure, often accompanied by pain, are also reported by many women. Some birthing parents report changes to the sensation of their genitals that are thought to be related to stretch of the pudendal nerve during parturition. Most experience resolution of these concerns within the first year after childbirth, although some women report persistent problems, including up to 33% with persistent sexual pain.

Many factors can contribute to postpartum sexual issues, including hormonal changes, body image concerns, and mental health conditions. Breastfeeding, for instance, can lead to vaginal dryness and reduced sexual arousal due to hormonal shifts. Body image issues and mood disorders like depression and anxiety can also adversely affect sexual function. Women with postpartum depression are more likely to experience sexual concerns, and the relationship between sexual difficulties and depression can be bidirectional.
 

Empowerment and Expectations

One commonly cited recommendation is to wait until 6 weeks postpartum before resuming penetrative intercourse after a normal vaginal delivery. However, this guideline lacks robust scientific backing. Many people might feel ready for sexual intercourse much sooner or, conversely, might not feel comfortable at the 6-week mark. As clinicians, we must empower our patients to trust their own bodies and make decisions based on their comfort and readiness.

The 6-week advice can sometimes unintentionally convey to women that they are not experts on their own bodies, or that any kind of sex is risky. Acknowledging the recovery timeline for every person is unique and various forms of sexual expression are safe can help foster a healthier approach to resuming sexual activities. In one study of postpartum sexual behavior, in the first 6 weeks after delivery, the most common kinds of sexual play included giving oral sex to a partner and solo sex. Between 80% and 90% have resumed vaginal-receiving sexual play (including intercourse) by 3 months. 

While recognizing that changes to sexual experience occur, we need to reinforce that gradual recovery is expected. And if women express distress about a sexual change, or if those changes persist, primary care providers should be prepared to help them with their concerns. 

Parents need to know experiencing pain is not something they should “just deal with” or ignore. Attempting to repeatedly endure sexual pain can cause new issues, such as high-tone dysfunction of the pelvic floor or an understandable decrease in willingness or receptiveness to sexual play of any kind. Encouraging open communication about these issues can help couples navigate these changes more smoothly.

Partners, especially new fathers, also experience sexual and emotional challenges. They can feel blindsided by the changes in their relationship and might struggle with feelings of jealousy or inadequacy. Understanding partners also face difficulties can help in providing a more comprehensive approach to sexual health care.
 

 

 

Starting the Conversation

So, how can we initiate these important conversations with new parents? Start by providing permission. As healthcare providers, we need to create an environment where discussing sexual health is normalized and welcomed. Simple, nonjudgmental statements can open the door to these discussions. For example, saying, “Many people notice changes in their sexual desire or pleasure after childbirth. Has anything like this happened to you or your partner?” can encourage patients to share their concerns.

Assessing the importance to patients of sexual problems can help direct the need for intervention. Follow up on these concerns and offer support, whether through counseling, pelvic floor physical therapy, or a referral to a sexual medicine specialist, a sex therapist, or other appropriate resource.

Let’s return to Sarah. In the ideal world, at 3 months postpartum she will already have had a handful of clinical conversations about her sexual well-being with her healthcare team — at prenatal visits, at well-baby visits, and at her postpartum checkups. Several of these conversations included her partner. They both understand the transition to parenthood could be rocky for their sex lives. They’ve set aside time to connect and stay physically close. She’s listened to her body and only engaged in sexual play for which she feels ready. Now, noting that some aspects of sexual play are persistently uncomfortable, she knows it’s time to follow up. Without shame or anxiety, she books an appointment with you, knowing that you understand how important this issue is for her, her partner, and her baby. 

If you’re working with new parents, remember: Open dialogue about sexual health is not just beneficial — it’s essential. Let’s bridge the gap in care by embracing these conversations and offering the support new parents truly need.
 

Dr. Kranz, Clinical Assistant Professor of Obstetrics/Gynecology and Family Medicine, University of Rochester Medical Center, Rochester, New York, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sarah, a new mom who’s thrilled about her 3-month-old baby, is struggling with her sex life. Her once vibrant physical relationship with her partner has dwindled, and she’s dealing with painful intercourse and a notable drop in desire.

Pregnancy and childbirth are transformative experiences that affect every facet of a person’s life, including their sexual well-being. Despite this fact, clinicians frequently ignore sexual well-being, beyond contraception, in prenatal and postpartum care. In peripartum care, anticipatory guidance is recognized to be crucial to the well-being of new parents and their babies. Why should sexual well-being get the shaft? 
 

Why Talk About Sex?

Sex is a fundamental aspect of many people’s lives and relationships and can significantly affect overall well-being. Despite cultural narratives that often exclude the sexual function and pleasure aspect of sexual health from peripartum discussions, many new parents face sexual challenges that can worsen their physical and emotional health.

While up to 88% of new parents report problems with sexual well-being, less than 30% report receiving anticipatory guidance about sexual function changes. One study found only 15% of postpartum women reported discussing sexual concerns with their medical providers. And, when new parents receive more information about sexual health, they tend to report improved sexual well-being. Clearly, a gap needs bridging.

Sexual health doesn’t just affect individual well-being; it intertwines with relationship satisfaction. Attending to satisfaction in one’s relationship may be an important component of child health as well. 

Declines in the frequency of sexual engagement and desire are common after childbirth. Changes in arousal, orgasm, and sexual pleasure, often accompanied by pain, are also reported by many women. Some birthing parents report changes to the sensation of their genitals that are thought to be related to stretch of the pudendal nerve during parturition. Most experience resolution of these concerns within the first year after childbirth, although some women report persistent problems, including up to 33% with persistent sexual pain.

Many factors can contribute to postpartum sexual issues, including hormonal changes, body image concerns, and mental health conditions. Breastfeeding, for instance, can lead to vaginal dryness and reduced sexual arousal due to hormonal shifts. Body image issues and mood disorders like depression and anxiety can also adversely affect sexual function. Women with postpartum depression are more likely to experience sexual concerns, and the relationship between sexual difficulties and depression can be bidirectional.
 

Empowerment and Expectations

One commonly cited recommendation is to wait until 6 weeks postpartum before resuming penetrative intercourse after a normal vaginal delivery. However, this guideline lacks robust scientific backing. Many people might feel ready for sexual intercourse much sooner or, conversely, might not feel comfortable at the 6-week mark. As clinicians, we must empower our patients to trust their own bodies and make decisions based on their comfort and readiness.

The 6-week advice can sometimes unintentionally convey to women that they are not experts on their own bodies, or that any kind of sex is risky. Acknowledging the recovery timeline for every person is unique and various forms of sexual expression are safe can help foster a healthier approach to resuming sexual activities. In one study of postpartum sexual behavior, in the first 6 weeks after delivery, the most common kinds of sexual play included giving oral sex to a partner and solo sex. Between 80% and 90% have resumed vaginal-receiving sexual play (including intercourse) by 3 months. 

While recognizing that changes to sexual experience occur, we need to reinforce that gradual recovery is expected. And if women express distress about a sexual change, or if those changes persist, primary care providers should be prepared to help them with their concerns. 

Parents need to know experiencing pain is not something they should “just deal with” or ignore. Attempting to repeatedly endure sexual pain can cause new issues, such as high-tone dysfunction of the pelvic floor or an understandable decrease in willingness or receptiveness to sexual play of any kind. Encouraging open communication about these issues can help couples navigate these changes more smoothly.

Partners, especially new fathers, also experience sexual and emotional challenges. They can feel blindsided by the changes in their relationship and might struggle with feelings of jealousy or inadequacy. Understanding partners also face difficulties can help in providing a more comprehensive approach to sexual health care.
 

 

 

Starting the Conversation

So, how can we initiate these important conversations with new parents? Start by providing permission. As healthcare providers, we need to create an environment where discussing sexual health is normalized and welcomed. Simple, nonjudgmental statements can open the door to these discussions. For example, saying, “Many people notice changes in their sexual desire or pleasure after childbirth. Has anything like this happened to you or your partner?” can encourage patients to share their concerns.

Assessing the importance to patients of sexual problems can help direct the need for intervention. Follow up on these concerns and offer support, whether through counseling, pelvic floor physical therapy, or a referral to a sexual medicine specialist, a sex therapist, or other appropriate resource.

Let’s return to Sarah. In the ideal world, at 3 months postpartum she will already have had a handful of clinical conversations about her sexual well-being with her healthcare team — at prenatal visits, at well-baby visits, and at her postpartum checkups. Several of these conversations included her partner. They both understand the transition to parenthood could be rocky for their sex lives. They’ve set aside time to connect and stay physically close. She’s listened to her body and only engaged in sexual play for which she feels ready. Now, noting that some aspects of sexual play are persistently uncomfortable, she knows it’s time to follow up. Without shame or anxiety, she books an appointment with you, knowing that you understand how important this issue is for her, her partner, and her baby. 

If you’re working with new parents, remember: Open dialogue about sexual health is not just beneficial — it’s essential. Let’s bridge the gap in care by embracing these conversations and offering the support new parents truly need.
 

Dr. Kranz, Clinical Assistant Professor of Obstetrics/Gynecology and Family Medicine, University of Rochester Medical Center, Rochester, New York, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Groups With Highest Unmet Need for PrEP Highlighted in Analysis

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Changed
Thu, 10/24/2024 - 03:48

— Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

 

 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

A version of this article first appeared on Medscape.com.

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— Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

 

 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

A version of this article first appeared on Medscape.com.

— Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

 

 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

A version of this article first appeared on Medscape.com.

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Contraceptive Users in the United States Show Preference for Alternative Sources

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Tue, 10/22/2024 - 11:39

 

TOPLINE:

Individuals using contraceptive pills, patches, and rings must frequently interact with the healthcare system for continued use. More than half of US contraceptive users prefer alternative sources over traditional in-person care. Only 35.6% of respondents selected in-person care as their most preferred source.

METHODOLOGY:

  • Researchers conducted a cross-sectional nationally representative survey in the United States in 2022 through NORC’s AmeriSpeak panel.
  • A total of 3059 eligible panelists, aged 15-44 years, completed the survey, with 595 individuals currently using a pill, patch, or ring contraceptive included in the analysis.
  • Primary outcomes measured were the use of any preferred source and the most preferred source when obtaining contraception.
  • Sources included in-person care, telehealth, pharmacist-prescribed, online service, and over the counter.
  • Data were analyzed from January 25, 2023, to August 15, 2024.

TAKEAWAY:

  • Only 35.6% of respondents selected in-person care as their most preferred source of contraception.
  • Only 49.7% of respondents obtained their method from a preferred source, while 39.8% received it from their most preferred source.
  • Respondents who previously reported being unable to get their method on time had higher odds of preferring an alternative source (adjusted odds ratio [AOR], 2.57; 95% CI, 1.36-4.87).
  • Those who recently received person-centered contraceptive counseling had lower odds of preferring an alternative source (AOR, 0.59; 95% CI, 0.35-0.98).

IN PRACTICE:

“The low level of preference for in-person care suggests that expanding contraceptive sources outside of traditional healthcare settings has a role in ameliorating barriers to access and can promote reproductive autonomy,” wrote the authors of the study.

SOURCE:

The study was led by Anu Manchikanti Gómez, PhD, Sexual Health and Reproductive Equity Program, School of Social Welfare, University of California, Berkeley. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s cross-sectional design limited the ability to establish causality. The sample was limited to individuals aged 15-44 years, which may not represent all contraceptive users. Self-reported data may be subject to recall bias. The study did not distinguish between synchronous and asynchronous telehealth preferences.

DISCLOSURES:

The study was supported by Arnold Ventures. Gómez disclosed receiving personal fees from various organizations outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Individuals using contraceptive pills, patches, and rings must frequently interact with the healthcare system for continued use. More than half of US contraceptive users prefer alternative sources over traditional in-person care. Only 35.6% of respondents selected in-person care as their most preferred source.

METHODOLOGY:

  • Researchers conducted a cross-sectional nationally representative survey in the United States in 2022 through NORC’s AmeriSpeak panel.
  • A total of 3059 eligible panelists, aged 15-44 years, completed the survey, with 595 individuals currently using a pill, patch, or ring contraceptive included in the analysis.
  • Primary outcomes measured were the use of any preferred source and the most preferred source when obtaining contraception.
  • Sources included in-person care, telehealth, pharmacist-prescribed, online service, and over the counter.
  • Data were analyzed from January 25, 2023, to August 15, 2024.

TAKEAWAY:

  • Only 35.6% of respondents selected in-person care as their most preferred source of contraception.
  • Only 49.7% of respondents obtained their method from a preferred source, while 39.8% received it from their most preferred source.
  • Respondents who previously reported being unable to get their method on time had higher odds of preferring an alternative source (adjusted odds ratio [AOR], 2.57; 95% CI, 1.36-4.87).
  • Those who recently received person-centered contraceptive counseling had lower odds of preferring an alternative source (AOR, 0.59; 95% CI, 0.35-0.98).

IN PRACTICE:

“The low level of preference for in-person care suggests that expanding contraceptive sources outside of traditional healthcare settings has a role in ameliorating barriers to access and can promote reproductive autonomy,” wrote the authors of the study.

SOURCE:

The study was led by Anu Manchikanti Gómez, PhD, Sexual Health and Reproductive Equity Program, School of Social Welfare, University of California, Berkeley. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s cross-sectional design limited the ability to establish causality. The sample was limited to individuals aged 15-44 years, which may not represent all contraceptive users. Self-reported data may be subject to recall bias. The study did not distinguish between synchronous and asynchronous telehealth preferences.

DISCLOSURES:

The study was supported by Arnold Ventures. Gómez disclosed receiving personal fees from various organizations outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Individuals using contraceptive pills, patches, and rings must frequently interact with the healthcare system for continued use. More than half of US contraceptive users prefer alternative sources over traditional in-person care. Only 35.6% of respondents selected in-person care as their most preferred source.

METHODOLOGY:

  • Researchers conducted a cross-sectional nationally representative survey in the United States in 2022 through NORC’s AmeriSpeak panel.
  • A total of 3059 eligible panelists, aged 15-44 years, completed the survey, with 595 individuals currently using a pill, patch, or ring contraceptive included in the analysis.
  • Primary outcomes measured were the use of any preferred source and the most preferred source when obtaining contraception.
  • Sources included in-person care, telehealth, pharmacist-prescribed, online service, and over the counter.
  • Data were analyzed from January 25, 2023, to August 15, 2024.

TAKEAWAY:

  • Only 35.6% of respondents selected in-person care as their most preferred source of contraception.
  • Only 49.7% of respondents obtained their method from a preferred source, while 39.8% received it from their most preferred source.
  • Respondents who previously reported being unable to get their method on time had higher odds of preferring an alternative source (adjusted odds ratio [AOR], 2.57; 95% CI, 1.36-4.87).
  • Those who recently received person-centered contraceptive counseling had lower odds of preferring an alternative source (AOR, 0.59; 95% CI, 0.35-0.98).

IN PRACTICE:

“The low level of preference for in-person care suggests that expanding contraceptive sources outside of traditional healthcare settings has a role in ameliorating barriers to access and can promote reproductive autonomy,” wrote the authors of the study.

SOURCE:

The study was led by Anu Manchikanti Gómez, PhD, Sexual Health and Reproductive Equity Program, School of Social Welfare, University of California, Berkeley. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s cross-sectional design limited the ability to establish causality. The sample was limited to individuals aged 15-44 years, which may not represent all contraceptive users. Self-reported data may be subject to recall bias. The study did not distinguish between synchronous and asynchronous telehealth preferences.

DISCLOSURES:

The study was supported by Arnold Ventures. Gómez disclosed receiving personal fees from various organizations outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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One-Dose HPV Vaccine Program Would Be Efficient in Canada

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Changed
Thu, 11/07/2024 - 05:42

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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Sperm Appear to Have a Nonreproductive Function

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Changed
Tue, 10/15/2024 - 09:36

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Transgender Women and Prostate Cancer: It’s Complicated

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Tue, 11/05/2024 - 11:46

The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

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The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

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Tue, 09/24/2024 - 11:59

Harnessing Doxycycline for STI Prevention: A Vital Role for Primary Care Physicians

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Thu, 09/19/2024 - 16:35

Primary care physicians frequently offer postexposure prophylaxis for various infections, including influenza, pertussis, tetanus, hepatitis, and Lyme disease, among others. However, the scope of postexposure prophylaxis in primary care is expanding, presenting an opportunity to further integrate it into patient care. As primary care providers, we have the unique advantage of being involved in both preventive care and immediate response, particularly in urgent care or triage scenarios. This dual role is crucial, as timely administration of postexposure prophylaxis can prevent infections from taking hold, especially following high-risk exposures.

Recently, the use of doxycycline as a form of postexposure prophylaxis for sexually transmitted infections (STIs) has gained attention. Traditionally, doxycycline has been used as preexposure or postexposure prophylaxis for conditions like malaria and Lyme disease but has not been widely employed for STI prevention until now. Doxycycline is a relatively common medication, generally safe with side effects that typically resolve upon discontinuation. Several open-label studies have shown that taking 200 mg of doxycycline within 72 hours of condomless sex significantly reduces the incidence of chlamydia, gonorrhea, and syphilis among gay, bisexual, and other men who have sex with men, as well as transgender women who have previously had a bacterial STI. However, these benefits have not been consistently observed among cisgender women and heterosexual men.

Dr. Santina J.G. Wheat

Given these findings, the Centers for Disease Control and Prevention now recommends that clinicians discuss the risks and benefits of doxycycline PEP (Doxy PEP) with gay, bisexual, and other men who have sex with men, as well as transgender women who have had a bacterial STI in the past 12 months. This discussion should be part of a shared decision-making process, advising the use of 200 mg of doxycycline within 72 hours of oral, vaginal, or anal sex, with the recommendation not to exceed 200 mg every 24 hours and to reassess the need for continued use every 3-6 months. Doxy PEP can be safely prescribed with preexposure prophylaxis for HIV (PrEP). Patients who receive PrEP may often be eligible for Doxy PEP, though the groups are not always the same.

The shared decision-making process is essential when considering Doxy PEP. While cost-effective and proven to reduce the risk of gonorrhea, chlamydia, and syphilis, its benefits vary among different populations. Moreover, some patients may experience side effects such as photosensitivity and gastrointestinal discomfort. Since the effectiveness of prophylaxis is closely tied to the timing of exposure and the patient’s current risk factors, it is important to regularly evaluate whether Doxy PEP remains beneficial. As there is not yet clear benefit to heterosexual men and cisgender women, opportunities still need to be explored for them.

Integrating Doxy PEP into a primary care practice can be done efficiently. A standing order protocol could be established for telehealth visits or nurse triage, allowing timely administration when patients report an exposure within 72 hours. It could also be incorporated into electronic medical records as part of a smart set for easy access to orders and as standard educational material in after-visit instructions. As this option is new, it is also important to discuss it with patients before they may need it so that they are aware should the need arise. While concerns about antibiotic resistance are valid, studies have not yet shown significant resistance issues related to Doxy PEP use, though ongoing monitoring is necessary.

You might wonder why primary care should prioritize this intervention. As the first point of contact, primary care providers are well-positioned to identify the need for prophylaxis, particularly since its effectiveness diminishes over time. Furthermore, the established, trusting relationships that primary care physicians often have with their patients create a nonjudgmental environment that encourages disclosure of potential exposures. This trust, combined with easier access to care, can make a significant difference in the timely provision of postexposure prophylaxis. By offering comprehensive, holistic care, including prophylaxis, primary care physicians can prevent infections and address conditions before they lead to serious complications. Therefore, family medicine physicians should consider incorporating Doxy PEP into their practices as a standard of care.
 

Dr. Wheat is vice chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine, and associate professor, Family and Community Medicine, at Northwestern University’s Feinberg School of Medicine, Chicago. She has no relevant financial disclosures.

References

Bachmann LH et al. CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. MMWR Recomm Rep 2024;73(No. RR-2):1-8.

Traeger MW et al. Potential Impact of Doxycycline Postexposure Prophylaxis Prescribing Strategies on Incidence of Bacterial Sexually Transmitted Infections. (Clin Infect Dis. 2023 Aug 18. doi: 10.1093/cid/ciad488).

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Primary care physicians frequently offer postexposure prophylaxis for various infections, including influenza, pertussis, tetanus, hepatitis, and Lyme disease, among others. However, the scope of postexposure prophylaxis in primary care is expanding, presenting an opportunity to further integrate it into patient care. As primary care providers, we have the unique advantage of being involved in both preventive care and immediate response, particularly in urgent care or triage scenarios. This dual role is crucial, as timely administration of postexposure prophylaxis can prevent infections from taking hold, especially following high-risk exposures.

Recently, the use of doxycycline as a form of postexposure prophylaxis for sexually transmitted infections (STIs) has gained attention. Traditionally, doxycycline has been used as preexposure or postexposure prophylaxis for conditions like malaria and Lyme disease but has not been widely employed for STI prevention until now. Doxycycline is a relatively common medication, generally safe with side effects that typically resolve upon discontinuation. Several open-label studies have shown that taking 200 mg of doxycycline within 72 hours of condomless sex significantly reduces the incidence of chlamydia, gonorrhea, and syphilis among gay, bisexual, and other men who have sex with men, as well as transgender women who have previously had a bacterial STI. However, these benefits have not been consistently observed among cisgender women and heterosexual men.

Dr. Santina J.G. Wheat

Given these findings, the Centers for Disease Control and Prevention now recommends that clinicians discuss the risks and benefits of doxycycline PEP (Doxy PEP) with gay, bisexual, and other men who have sex with men, as well as transgender women who have had a bacterial STI in the past 12 months. This discussion should be part of a shared decision-making process, advising the use of 200 mg of doxycycline within 72 hours of oral, vaginal, or anal sex, with the recommendation not to exceed 200 mg every 24 hours and to reassess the need for continued use every 3-6 months. Doxy PEP can be safely prescribed with preexposure prophylaxis for HIV (PrEP). Patients who receive PrEP may often be eligible for Doxy PEP, though the groups are not always the same.

The shared decision-making process is essential when considering Doxy PEP. While cost-effective and proven to reduce the risk of gonorrhea, chlamydia, and syphilis, its benefits vary among different populations. Moreover, some patients may experience side effects such as photosensitivity and gastrointestinal discomfort. Since the effectiveness of prophylaxis is closely tied to the timing of exposure and the patient’s current risk factors, it is important to regularly evaluate whether Doxy PEP remains beneficial. As there is not yet clear benefit to heterosexual men and cisgender women, opportunities still need to be explored for them.

Integrating Doxy PEP into a primary care practice can be done efficiently. A standing order protocol could be established for telehealth visits or nurse triage, allowing timely administration when patients report an exposure within 72 hours. It could also be incorporated into electronic medical records as part of a smart set for easy access to orders and as standard educational material in after-visit instructions. As this option is new, it is also important to discuss it with patients before they may need it so that they are aware should the need arise. While concerns about antibiotic resistance are valid, studies have not yet shown significant resistance issues related to Doxy PEP use, though ongoing monitoring is necessary.

You might wonder why primary care should prioritize this intervention. As the first point of contact, primary care providers are well-positioned to identify the need for prophylaxis, particularly since its effectiveness diminishes over time. Furthermore, the established, trusting relationships that primary care physicians often have with their patients create a nonjudgmental environment that encourages disclosure of potential exposures. This trust, combined with easier access to care, can make a significant difference in the timely provision of postexposure prophylaxis. By offering comprehensive, holistic care, including prophylaxis, primary care physicians can prevent infections and address conditions before they lead to serious complications. Therefore, family medicine physicians should consider incorporating Doxy PEP into their practices as a standard of care.
 

Dr. Wheat is vice chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine, and associate professor, Family and Community Medicine, at Northwestern University’s Feinberg School of Medicine, Chicago. She has no relevant financial disclosures.

References

Bachmann LH et al. CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. MMWR Recomm Rep 2024;73(No. RR-2):1-8.

Traeger MW et al. Potential Impact of Doxycycline Postexposure Prophylaxis Prescribing Strategies on Incidence of Bacterial Sexually Transmitted Infections. (Clin Infect Dis. 2023 Aug 18. doi: 10.1093/cid/ciad488).

Primary care physicians frequently offer postexposure prophylaxis for various infections, including influenza, pertussis, tetanus, hepatitis, and Lyme disease, among others. However, the scope of postexposure prophylaxis in primary care is expanding, presenting an opportunity to further integrate it into patient care. As primary care providers, we have the unique advantage of being involved in both preventive care and immediate response, particularly in urgent care or triage scenarios. This dual role is crucial, as timely administration of postexposure prophylaxis can prevent infections from taking hold, especially following high-risk exposures.

Recently, the use of doxycycline as a form of postexposure prophylaxis for sexually transmitted infections (STIs) has gained attention. Traditionally, doxycycline has been used as preexposure or postexposure prophylaxis for conditions like malaria and Lyme disease but has not been widely employed for STI prevention until now. Doxycycline is a relatively common medication, generally safe with side effects that typically resolve upon discontinuation. Several open-label studies have shown that taking 200 mg of doxycycline within 72 hours of condomless sex significantly reduces the incidence of chlamydia, gonorrhea, and syphilis among gay, bisexual, and other men who have sex with men, as well as transgender women who have previously had a bacterial STI. However, these benefits have not been consistently observed among cisgender women and heterosexual men.

Dr. Santina J.G. Wheat

Given these findings, the Centers for Disease Control and Prevention now recommends that clinicians discuss the risks and benefits of doxycycline PEP (Doxy PEP) with gay, bisexual, and other men who have sex with men, as well as transgender women who have had a bacterial STI in the past 12 months. This discussion should be part of a shared decision-making process, advising the use of 200 mg of doxycycline within 72 hours of oral, vaginal, or anal sex, with the recommendation not to exceed 200 mg every 24 hours and to reassess the need for continued use every 3-6 months. Doxy PEP can be safely prescribed with preexposure prophylaxis for HIV (PrEP). Patients who receive PrEP may often be eligible for Doxy PEP, though the groups are not always the same.

The shared decision-making process is essential when considering Doxy PEP. While cost-effective and proven to reduce the risk of gonorrhea, chlamydia, and syphilis, its benefits vary among different populations. Moreover, some patients may experience side effects such as photosensitivity and gastrointestinal discomfort. Since the effectiveness of prophylaxis is closely tied to the timing of exposure and the patient’s current risk factors, it is important to regularly evaluate whether Doxy PEP remains beneficial. As there is not yet clear benefit to heterosexual men and cisgender women, opportunities still need to be explored for them.

Integrating Doxy PEP into a primary care practice can be done efficiently. A standing order protocol could be established for telehealth visits or nurse triage, allowing timely administration when patients report an exposure within 72 hours. It could also be incorporated into electronic medical records as part of a smart set for easy access to orders and as standard educational material in after-visit instructions. As this option is new, it is also important to discuss it with patients before they may need it so that they are aware should the need arise. While concerns about antibiotic resistance are valid, studies have not yet shown significant resistance issues related to Doxy PEP use, though ongoing monitoring is necessary.

You might wonder why primary care should prioritize this intervention. As the first point of contact, primary care providers are well-positioned to identify the need for prophylaxis, particularly since its effectiveness diminishes over time. Furthermore, the established, trusting relationships that primary care physicians often have with their patients create a nonjudgmental environment that encourages disclosure of potential exposures. This trust, combined with easier access to care, can make a significant difference in the timely provision of postexposure prophylaxis. By offering comprehensive, holistic care, including prophylaxis, primary care physicians can prevent infections and address conditions before they lead to serious complications. Therefore, family medicine physicians should consider incorporating Doxy PEP into their practices as a standard of care.
 

Dr. Wheat is vice chair of Diversity, Equity, and Inclusion, Department of Family and Community Medicine, and associate professor, Family and Community Medicine, at Northwestern University’s Feinberg School of Medicine, Chicago. She has no relevant financial disclosures.

References

Bachmann LH et al. CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. MMWR Recomm Rep 2024;73(No. RR-2):1-8.

Traeger MW et al. Potential Impact of Doxycycline Postexposure Prophylaxis Prescribing Strategies on Incidence of Bacterial Sexually Transmitted Infections. (Clin Infect Dis. 2023 Aug 18. doi: 10.1093/cid/ciad488).

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Long-Term Exposure to Road Traffic Noise and Air Pollution Linked to Infertility

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Mon, 09/16/2024 - 12:51

 

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

  • This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
  • Residential exposure to road traffic noise (most exposed facade of the home) and PM2.5 was estimated using validated models and linked to data from national registers.
  • Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

  • Each 2.9 µg/m3 increase in the 5-year average exposure to PM2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
  • No significant association was found between exposure to PM2.5 and infertility in women.
  • Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
  • Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

  • This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
  • Residential exposure to road traffic noise (most exposed facade of the home) and PM2.5 was estimated using validated models and linked to data from national registers.
  • Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

  • Each 2.9 µg/m3 increase in the 5-year average exposure to PM2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
  • No significant association was found between exposure to PM2.5 and infertility in women.
  • Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
  • Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Long-term exposure to particulate matter < 2.5 μm in diameter (PM2.5) is linked to a higher risk for infertility in men. Exposure to road traffic noise is associated with a higher risk for infertility in women aged > 35 years and possibly in men aged > 37 years.

METHODOLOGY:

  • This nationwide prospective cohort study evaluated the association between long-term exposure to road traffic noise and PM2.5 and infertility in 526,056 men (mean age, 33.6 years) and 377,850 women (mean age, 32.7 years) who were cohabiting or married, had fewer than two children, and lived in Denmark between 2000 and 2017.
  • Residential exposure to road traffic noise (most exposed facade of the home) and PM2.5 was estimated using validated models and linked to data from national registers.
  • Diagnoses of infertility were identified in men and women from the Danish National Patient Register over a mean follow-up of 4.3 years and 4.2 years, respectively.

TAKEAWAY:

  • Each 2.9 µg/m3 increase in the 5-year average exposure to PM2.5 was associated with a 24% increase in the risk for infertility in men aged 30-45 years (adjusted hazard ratio [aHR], 1.24).
  • No significant association was found between exposure to PM2.5 and infertility in women.
  • Each 10.2 dB increase in the 5-year average exposure to road traffic noise was associated with a 14% increase in infertility (aHR, 1.14; 95% CI, 1.10-1.18) in women aged 35-45 years.
  • Exposure to noise was associated with a reduced risk for infertility in men aged 30.0-36.9 years (aHR, 0.93; 95% CI, 0.91-0.96) and an increased risk in those aged 37-45 years (aHR, 1.06; 95% CI, 1.02-1.11).

IN PRACTICE:

“As many Western countries are facing declining birth rates and increasing maternal age at the birth of a first child, knowledge on environmental pollutants affecting fertility is crucial,” the authors of the study wrote. “It suggests that political implementation of air pollution and noise mitigations may be important tools for improving birth rates in the Western world,” they added.

SOURCE:

The study, led by Mette Sorensen, of the Danish Cancer Institute in Copenhagen, Denmark, was published online in The BMJ.

LIMITATIONS:

The study’s reliance on register data meant information on lifestyle factors such as alcohol use, body mass index, and smoking was unavailable. The lack of data on exposure to noise and PM2.5 at work and during leisure activities may affect the size and statistical precision of risk estimates.

DISCLOSURES:

The study did not receive any external funding. The authors declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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