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Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
FROM JAMA PEDIATRICS
Key clinical point: With monthly clinic visits, about half of adolescent men who had sex with men were able to maintain highly protective blood levels of pre-exposure prophylaxis.
Major finding: Up to 54% of participants maintained tenofovir disphosphate levels above 700 fmol/punch when they attended monthly visits, but as few as 17% did so after switching to quarterly visits.
Data source: A multicenter, open-label clinical trial of 78 high-risk men who had sex with men aged 15-17 years.
Disclosures: Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.