Evidence map›Paper›PMID 42431361›Full record

ArticleContemporary clinical trials2026

Life-steps for PrEP nurse-delivered adherence intervention: Protocol for a multisite randomized clinical trial.

Marc Puccinelli, Kenneth H Mayer, Juan A Esquivel-Mendoza, Alexandra Porras, Christina Psaros, Douglas Krakower, Susanne Doblecki-Lewis, Peter L Anderson, Matthew J Mimiaga, Steven A Safren

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Marc PuccinelliDepartment of Psychology, University of Miami, Miami, FL, USA. Electronic address: mpuccinelli@miami.edu.
Kenneth H MayerFenway Heath and Harvard Medical School, Boston, MA, USA.
Juan A Esquivel-MendozaDepartment of Psychology, University of Miami, Miami, FL, USA.
Alexandra PorrasDepartment of Psychology, University of Miami, Miami, FL, USA.
Christina PsarosDepartment of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Douglas KrakowerDivision of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA, USA; Fenway Heath and Harvard Medical School, Boston, MA, USA.
Susanne Doblecki-LewisDivision of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
Peter L AndersonDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Matthew J MimiagaDepartment of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, USA.
Steven A SafrenDepartment of Psychology, University of Miami, Miami, FL, USA.

Funding

The University of Miami AIDS Research Center on Mental Health and HIV/AIDS - Center for HIV & Research in Mental Health (CHARM)Research Core & MHD-CEP30MH133399 · NIMH · UNIVERSITY OF MIAMI CORAL GABLES · PI Victoria Behar-Zusman · 2023 to 2026
$8.9M
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP CareR01MH118043 · NIMH · UNIVERSITY OF MIAMI CORAL GABLES · PI MAYER, KENNETH H, SAFREN, STEVEN A · 2019 to 2023
$3.7M
NIMH NIH HHS P30 MH133399NIMH NIH HHS R01 MH118043
6 · The paper itself

Abstract

backgroundPre-exposure prophylaxis (PrEP) is effective in preventing HIV; however, syndemically linked psychosocial problems can contribute to adherence challenges.

objectiveThe aim of this study is to test the efficacy of a stepped-care (text messaging, followed adherence counseling) PrEP intervention in men who have sex with men (cisgender or transgender) who are at risk for HIV acquisition and potentially PrEP non-adherence. Secondary and exploratory aims include examining mediators, moderators, and cost-effectiveness.

methodsThis 2-arm randomized controlled trial enrolled 300 men who have sex with men reporting at least one syndemically-linked psychosocial problem (e.g., polysubstance use, depression symptoms) prescribed PrEP. Recruitment sites in Miami, FL and Boston, MA equally randomized participants to standard care or the stepped-care intervention, which includes daily text message reminders, access to nurses, and, if continued non-adherence, four Life-Steps adherence counseling sessions (and two potential boosters). Study participation lasted 18 months with baseline and 6 quarterly assessment visits that included dried blood spot (DBS) testing for PrEP medication metabolites (TFV-DP) and self-reported adherence as primary outcomes.

resultsParticipant related activities will be completed by July 2025.

conclusionWe hypothesize that this ongoing study will demonstrate that participants will have better adherence over 18 months in the stepped-care / Life-Steps intervention relative to the standard of care condition. Positive outcomes from the present study may support an efficient model to deliver an effective adherence intervention to those with greater need.

Indexed as

Anti-HIV AgentsCounselingHIV InfectionsHomosexuality, MaleMedication AdherencePre-Exposure ProphylaxisText MessagingAdherence InterventionsAdultCost-Benefit AnalysisCost-Effectiveness AnalysisHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicAnti-HIV AgentsClinical trialHIVLife-steps interventionMedication adherencePrEPSexual minorityStepped-care

Identifiers

PMID42431361
PMCPMC13449095

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.