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Original Investigation
September 5, 2017

Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States

Author Affiliations
  • 1Stroger Hospital of Cook County, Chicago, Illinois
  • 2University of California–Los Angeles, Los Angeles
  • 3National Institute of Child Health and Human Development, Bethesda, Maryland
  • 4New York University, New York
  • 5Westat, Rockville, Maryland
  • 6University of California–San Francisco, San Francisco
  • 7Indiana University, Indianapolis
  • 8Fenway Institute, Boston, Massachusetts
  • 9University of Colorado–Denver, Denver
  • 10Brown University, Providence, Rhode Island
  • 11Ruth Rothstein CORE Center, Chicago, Illinois
  • 12Gilead Sciences, Foster City, California
  • 13University of Alabama–Birmingham, Birmingham
JAMA Pediatr. Published online September 5, 2017. doi:10.1001/jamapediatrics.2017.2007
Key Points

Question  Is human immunodeficiency virus preexposure prophylaxis safe and feasible to use for adolescent men who sex with men?

Findings  In this study, preexposure prophylaxis was found to be safe and well-tolerated, but adherence to the daily pill waned. Rates of sexually transmitted infections were high and human immunodeficiency virus infections occurred among those with poor adherence.

Meaning  Adolescent men who have sex with men who are at risk of contracting the human immunodeficiency virus should be offered access to preexposure prophylaxis with appropriate behavioral support to maintain adherence.


Importance  Adolescents represent a key population for implementing preexposure prophylaxis (PrEP) interventions worldwide, yet tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for PrEP is only licensed for adults.

Objective  To examine the safety of and adherence to PrEP along with changes in sexual risk behavior among adolescent men who have sex with men (MSM).

Design, Setting, and Participants  Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) was a PrEP demonstration project that evaluated the safety, tolerability, and acceptability of TDF/FTC and patterns of use, rates of adherence, and patterns of sexual risk behavior among healthy young MSM aged 15 to 17 years. Participants were recruited from adolescent medicine clinics and their community partners in 6 US cities, had negative test results for human immunodeficiency virus (HIV) but were at high risk for acquiring an infection, and were willing to participate in a behavioral intervention and accept TDF/FTC as PrEP.

Exposures  All participants completed an individualized evidence-based behavioral intervention and were provided with daily TDF/FTC as PrEP for 48 weeks.

Main Outcomes and Measures  The main objectives were to: (1) provide additional safety data regarding TDF/FTC use among young MSM who had negative test results for HIV; (2) examine the acceptability, patterns of use, rates of adherence, and measured levels of tenofovir diphosphate in dried blood spots; and (3) examine patterns of risk behavior when young MSM were provided with a behavioral intervention in conjunction with open-label TDF/FTC.

Results  Among 2864 individuals screened (from August 2013 to September 2014), 260 were eligible and 78 were enrolled (mean [SD] age, 16.5 [0.73] years), of whom 2 (3%) were Asian/Pacific Islander, 23 (29%) were black/African American, 11 (14%) were white, 16 (21%) were white Hispanic, and 26 (33%) were other/mixed race/ethnicity. Over 48 weeks of PrEP use, 23 sexually transmitted infections were diagnosed in 12 participants. The HIV seroconversion rate was 6.4 (95% CI: 1.3-18.7) per 100 person-years. Tenofovir diphosphate levels consistent with a high degree of anti-HIV protection (>700 fmol/punch) were found in 42 (54%), 37 (47%), 38 (49%), 22 (28%), 13 (17%), and 17 (22%) participants at weeks 4, 8, 12, 24, 36, and 48, respectively.

Conclusions and Relevance  Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 enrolled a diverse sample of adolescent MSM at risk for HIV who consented to study participation. Approximately half achieved protective drug levels during the monthly visits, but adherence decreased with quarterly visits. Youth may need additional contact with clinical staff members to maintain high adherence.

Trial Registration  clinicaltrials.gov Identifier: NCT01769456