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Original Investigation
January 2016

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services

Author Affiliations
  • 1San Francisco Department of Public Health, San Francisco, California
  • 2Department of Medicine, University of California, San Francisco
  • 3Department of Epidemiology and Biostatistics, University of California, San Francisco
  • 4Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora
  • 5Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida
  • 6Division of AIDS, National Institutes of Health, Bethesda, Maryland
  • 7DF/Net Research, Inc, Seattle, Washington
  • 8Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor
  • 9Gilead Sciences, Foster City, California
  • 10Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida
  • 11Whitman-Walker Health, Washington, DC
  • 12Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida
  • 13Gladstone Institutes, San Francisco, California
  • 14San Francisco AIDS Foundation, San Francisco, California
  • 15Department of Medicine, George Washington University School of Medicine, Washington, DC
JAMA Intern Med. 2016;176(1):75-84. doi:10.1001/jamainternmed.2015.4683

Importance  Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).

Objective  To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.

Design, Setting, and Participants  Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.

Interventions  A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.

Main Outcomes and Measures  Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.

Results  Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.

Conclusions and Relevance  The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.