Evidence map›Paper›PMID 27848089›Full record

Trial reportAIDS and behavior2017

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 and 1 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AIDS and behavior, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  20. Meta-Modeling as a Variance-Reduction Technique for Stochastic Model-Based Cost-Effectiveness Analyses.Medical decision making : an international journal of the Society for Medical Decision Making · 2025
    Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kenneth H MayerThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA. kmayer@fenwayhealth.org.
Steven A SafrenThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
Steven A ElsesserThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
Christina PsarosMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Jake P TinsleyThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
Mark MarzinkeJohns Hopkins University, Baltimore, MD, USA.
William ClarkeJohns Hopkins University, Baltimore, MD, USA.
Craig HendrixJohns Hopkins University, Baltimore, MD, USA.
S Wade TaylorThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.
Jessica HabererMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Matthew J MimiagaThe Fenway Institute, Fenway Health, 1340 Boylston St, Boston, MA, 02215, USA.

Funding

University of Miami Developmental Center for AIDS Research (D-CFAR)P30AI073961 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI GWENDOLYN Barbara SCOTT · 2007 to 2026
$33.8M
Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSMR34MH095584 · NIMH · FENWAY COMMUNITY HEALTH CENTER · PI MAYER, KENNETH H · 2011 to 2013
$739k
NIAID NIH HHS P30 AI073961NIMH NIH HHS R34 MH095584
6 · The paper itself

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.

Indexed as

CounselingAdultAnti-HIV AgentsCognitive Behavioral TherapyDrug MonitoringHIV InfectionsHumansMaleMedication AdherenceOutcome Assessment, Health CarePilot ProjectsPre-Exposure ProphylaxisTenofovirYoung AdultAnti-HIV AgentsTenofovirHIVMedication adherenceMSMPre-exposure antiretroviral prophylaxis

Identifiers

PMID27848089
PMCPMC5380582

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.