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”

Kenneth H. Mayer, Steven A. Safren, Steven A. Elsesser, Christina Psaros, Jake P. Tinsley, Mark Marzinke, William Clarke, Craig Hendrix, S. Wade Taylor, Jessica Haberer, Matthew J. Mimiaga

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1350-1360
Number of pages11
JournalAIDS and Behavior
Volume21
Issue number5
DOIs
StatePublished - May 1 2017

Keywords

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

ASJC Scopus subject areas

  • Social Psychology
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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