An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM

the Adolescent Trials Network (ATN) for HIVAIDS Interventions

Research output: Contribution to journalArticle

85 Citations (Scopus)

Abstract

Background: Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. METHODS:: Eligible participants were 18-22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). RESULTS:: Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. CONCLUSIONS:: Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.

Original languageEnglish (US)
JournalJournal of Acquired Immune Deficiency Syndromes
DOIs
StateAccepted/In press - Sep 13 2016

Fingerprint

HIV
Safety
Sexual Behavior
HIV Seropositivity
Protective Agents
Syphilis
Sexually Transmitted Diseases
Risk-Taking
Hispanic Americans
Appointments and Schedules
tenofovir diphosphate
Pre-Exposure Prophylaxis
Infection
Population
Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases

Cite this

An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM. / the Adolescent Trials Network (ATN) for HIVAIDS Interventions.

In: Journal of Acquired Immune Deficiency Syndromes, 13.09.2016.

Research output: Contribution to journalArticle

@article{7c9b89c5424b495aa2da4c70f0d14890,
title = "An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM",
abstract = "Background: Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. METHODS:: Eligible participants were 18-22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada{\circledR}). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). RESULTS:: Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5{\%} Black, 26.5{\%} Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22{\%} and remained high across visits. At week 4, 56{\%} of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34{\%} of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80{\%} of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. CONCLUSIONS:: Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.",
author = "{the Adolescent Trials Network (ATN) for HIVAIDS Interventions} and Sybil Hosek and Bret Rudy and Raphael Landovitz and Bill Kapogiannis and George Siberry and Brandy Rutledge and Nancy Liu and Jennifer Brothers and Kathleen Mulligan and Gregory Zimet and Michelle Lally and Ken Mayer and Peter Anderson and Jennifer Kiser and Jim Rooney and Wilson, {Craig M.}",
year = "2016",
month = "9",
day = "13",
doi = "10.1097/QAI.0000000000001179",
language = "English (US)",
journal = "Journal of Acquired Immune Deficiency Syndromes",
issn = "1525-4135",
publisher = "Lippincott Williams and Wilkins",

}

TY - JOUR

T1 - An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM

AU - the Adolescent Trials Network (ATN) for HIVAIDS Interventions

AU - Hosek, Sybil

AU - Rudy, Bret

AU - Landovitz, Raphael

AU - Kapogiannis, Bill

AU - Siberry, George

AU - Rutledge, Brandy

AU - Liu, Nancy

AU - Brothers, Jennifer

AU - Mulligan, Kathleen

AU - Zimet, Gregory

AU - Lally, Michelle

AU - Mayer, Ken

AU - Anderson, Peter

AU - Kiser, Jennifer

AU - Rooney, Jim

AU - Wilson, Craig M.

PY - 2016/9/13

Y1 - 2016/9/13

N2 - Background: Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. METHODS:: Eligible participants were 18-22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). RESULTS:: Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. CONCLUSIONS:: Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.

AB - Background: Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities. METHODS:: Eligible participants were 18-22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP). RESULTS:: Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels. CONCLUSIONS:: Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.

UR - http://www.scopus.com/inward/record.url?scp=84987916837&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84987916837&partnerID=8YFLogxK

U2 - 10.1097/QAI.0000000000001179

DO - 10.1097/QAI.0000000000001179

M3 - Article

JO - Journal of Acquired Immune Deficiency Syndromes

JF - Journal of Acquired Immune Deficiency Syndromes

SN - 1525-4135

ER -