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 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 journalArticle

11 Citations (Scopus)

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)1-11
Number of pages11
JournalAIDS and Behavior
DOIs
StateAccepted/In press - Nov 15 2016

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Tenofovir
Counseling
Medication Adherence
Randomized Controlled Trials
HIV
Random Allocation
Nurses
Pre-Exposure Prophylaxis
Therapeutics

Keywords

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

ASJC Scopus subject areas

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

Cite this

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

In: AIDS and Behavior, 15.11.2016, p. 1-11.

Research output: Contribution to journalArticle

Mayer, Kenneth H. ; Safren, Steven ; Elsesser, Steven A. ; Psaros, Christina ; Tinsley, Jake P. ; Marzinke, Mark ; Clarke, William ; Hendrix, Craig ; Wade Taylor, S. ; Haberer, Jessica ; Mimiaga, Matthew J. / 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”. In: AIDS and Behavior. 2016 ; pp. 1-11.
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