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AIDS Behav. 2017 May;21(5):1350-1360. doi: 10.1007/s10461-016-1606-4.

Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence in Men Who Have Sex with Men: Results of a Pilot Randomized Controlled Trial of "Life-Steps for PrEP".

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The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard T.C. Chan School of Public Health, Boston, MA, USA.
The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
University of Miami, Miami, FL, USA.
Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Johns Hopkins University, Baltimore, MD, USA.
Wheelock College, Boston, MA, USA.
Brown University, Providence, RI, USA.


Antiretroviral pre-exposure prophylaxis (PrEP) has been demonstrated to decrease HIV acquisition in multiple efficacy trials, but medication adherence is critical, and was suboptimal in several studies. Fifty HIV-uninfected at risk men who have sex with men (MSM) were randomized to a cognitive behavioral intervention condition or a time and session-matched comparison counseling intervention. The experimental intervention entailed four nurse-delivered initial and two booster sessions based on Life-Steps, an ART treatment adherence intervention. The comparison condition provided information and supportive counseling. The primary analyses compared adherence (Wisepill and tenofovir plasma levels) at 3 and 6 months. Fifty-eight MSM were screened to enroll 50 participants. Median age was 38.2 years old, 86% were white; 64% had completed college. Wisepill adherence was high in both groups, and not statistically different. Plasma tenofovir levels were significantly higher in the intervention group at 6 months using mean substitution analysis (i.e., computing missing variables) (p = 0.037), however, in the completer analyses (i.e., using only those completing all study visits), there were no statistically significant differences between randomization conditions. Medication adherence was high across a cognitive-behavioral (Life-Steps) and time-matched counseling intervention for PrEP adherence, with some evidence suggesting superiority of Life-Steps in this pilot RCT. Further evaluation in a fully powered efficacy trial is warranted to assess the robustness of this intervention.


HIV; MSM; Medication adherence; Pre-exposure antiretroviral prophylaxis

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