Background: Daily preexposure prophylaxis (PrEP) is an effective HIV prevention strategy, but adherence is required for maximum benefit. To date, there are no empirically supported PrEP adherence interventions. This article describes the process of developing a PrEP adherence intervention and presents results on its impact on adherence.
Methods: The Partners PrEP Study was a placebo-controlled efficacy trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among uninfected members of HIV-serodiscordant couples. An ancillary adherence study was conducted at 3 study sites in Uganda. Participants with <80% adherence as measured by unannounced pill count received an additional adherence counseling intervention based on Lifesteps, an evidence-based HIV treatment adherence intervention, based on principles of cognitive–behavioral theory.
Findings: Of the 1147 HIV-seronegative participants enrolled in the ancillary adherence study, 168 (14.6%) triggered the adherence intervention. Of participants triggering the intervention, 62% were men; median age was 32.5 years. The median number of adherence counseling sessions was 10. Mean adherence during the month before the intervention was 75.7% and increased significantly to 84.1% in the month after the first intervention session (P < 0.001). The most frequently endorsed adherence barriers at session 1 were travel and forgetting.
Interpretation: A PrEP adherence intervention was feasible in a clinical trial of PrEP in Uganda and PrEP adherence increased after the intervention. Future research should identify PrEP users with low adherence for enhanced adherence counseling and determine optimal implementation strategies for interventions to maximize PrEP effectiveness.
*Department of Psychiatry, Massachusetts General Hospital Center, Boston, MA;
†Harvard Medical School, Boston, MA;
‡Massachusetts General Hospital Center for Global Health, Boston, MA;
§Infectious Disease Institute, Makerere University, Kampala, Uganda;
‖Department of Internal Medicine, University of Manitoba, Winnipeg, Canada;
¶Kabwohe Clinical Research Center, Kabwohe, Uganda;
#Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Entebbe, Uganda;
**Department of Epidemiology, University of Washington, Seattle, WA;
††Harvard School of Public Health, Boston, MA;
‡‡Infectious Diseases Institute, Makerere University College of Health Science, Kampala, Uganda;
§§Department of Global Health, University of Washington, Seattle, WA;
‖‖Fred Hutchinson Cancer Research Center, Seattle, WA;
¶¶Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA; and
##Mbarara University of Science and Technology, Mbarara, Uganda.
Correspondence to: Christina Psaros, PhD, Behavioral Medicine Service, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 7th Floor, Boston, MA 02114 (e-mail: email@example.com).
Presented in part at the sixth and seventh International Conference on HIV Treatment and Prevention Adherence, May 23 - June 5, 2011, Miami, FL.
This study and the Partners PrEP Study were both supported by the Bill and Melinda Gates Foundation (Grants OOP47674 and OOP52516). Additional author time was supported by K23MH096651 (C.P.) and K24MH87227 (D.R.B.).
C.P. has served as a consultant to Bracket Global in the past; this work is unrelated to the submitted paper. The remaining authors have no conflicts of interest to disclose.
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Received January 23, 2014
Accepted May 01, 2014