title: 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".
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.
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA. kmayer@fenwayhealth.org.|Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard T.C. Chan School of Public Health, Boston, MA, USA. kmayer@fenwayhealth.org.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.|University of Miami, Miami, FL, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Safren
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.|Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Elsesser
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Psaros
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
authors.forename: Jake P
authors.initials: JP
authors.lastname: Tinsley
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Marzinke
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA.
authors.forename: William
authors.initials: W
authors.lastname: Clarke
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Hendrix
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.|Wheelock College, Boston, MA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Wade Taylor
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Haberer
authors.affiliation: The Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.|Brown University, Providence, RI, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Mimiaga
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003376:Counseling; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D000068698:Tenofovir / Q000008:administration & dosage*; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D019380:Anti-HIV Agents; D000068698:Tenofovir
keywords: HIV; MSM; Medication adherence; Pre-exposure antiretroviral prophylaxis