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Life-steps for PrEP nurse-delivered adherence intervention: Protocol for a multisite randomized clinical trial
Marc Puccinelli1, Kenneth H Mayer2, Juan A Esquivel-Mendoza1
1Department of Psychology, University of Miami, Miami, FL, USA.
Contemporary Clinical Trials
|July 10, 2026
Summary
This study tests a stepped-care intervention to improve adherence to HIV pre-exposure prophylaxis (PrEP) in men who have sex with men facing psychosocial challenges. The intervention, including text messages and counseling, aims to enhance PrEP adherence over 18 months.
Area of Science:
- Public Health
- Clinical Trials
- HIV Prevention
Background:
- Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method.
- Psychosocial issues can significantly impede PrEP adherence.
- Targeted interventions are needed for individuals at high risk of HIV acquisition and non-adherence.
Purpose of the Study:
- To evaluate the efficacy of a stepped-care intervention for PrEP adherence.
- To assess mediators, moderators, and cost-effectiveness of the intervention.
- To support individuals at risk for HIV acquisition and PrEP non-adherence.
Main Methods:
- A 2-arm randomized controlled trial involving 300 men who have sex with men with psychosocial challenges.
- Comparison of a stepped-care intervention (text messages, counseling) against standard care.
- 18-month study duration with quarterly assessments, including medication metabolite testing (TFV-DP) and self-reported adherence.
Main Results:
- Participant recruitment and study activities are ongoing.
- Primary outcomes include medication metabolite levels and self-reported adherence.
- Data collection is scheduled for completion by July 2025.
Conclusions:
- The stepped-care intervention is hypothesized to improve PrEP adherence compared to standard care.
- Positive findings could establish an efficient model for adherence support.
- This intervention targets individuals with significant adherence barriers.
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