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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".

Author information

1
The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA. kmayer@fenwayhealth.org.
2
Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard T.C. Chan School of Public Health, Boston, MA, USA. kmayer@fenwayhealth.org.
3
The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
4
University of Miami, Miami, FL, USA.
5
Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
6
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
7
Johns Hopkins University, Baltimore, MD, USA.
8
Wheelock College, Boston, MA, USA.
9
Brown University, Providence, RI, USA.

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.

KEYWORDS:

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

PMID:
27848089
PMCID:
PMC5380582
DOI:
10.1007/s10461-016-1606-4
[Indexed for MEDLINE]
Free PMC Article

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