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

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

The 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.

This 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.

Participant related activities will be completed by July 2025.

We 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.