# Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care

> **NIH NIH R01** · UNIVERSITY OF MIAMI CORAL GABLES · 2021 · $761,224

## Abstract

Background. Pre-exposure prophylaxis (PrEP) has dramatically changed the promise of HIV prevention,
particularly for gay, bisexual, and other men who have sex with men (MSM) who account for the majority of
HIV infections in the U.S. Accordingly, PrEP reduces HIV acquisition by >90% with adequate adherence.
However, many MSM face multiple challenges with respect to initiating, adhering to, and staying on PrEP, with
particular challenges for specific MSM subgroups, specifically those experiencing multiple psychosocial
problems—also known as syndemics—including depression; heavy alcohol use; polydrug use; history of
trauma or abuse; current interpersonal violence; as well as being a racial/ethnic minority MSM. Preliminary
Research. Life-Steps—a cognitive-behavioral therapy-based intervention—has successfully supported ART
treatment and prevention adherence in various studies. With funding from an NIMH R34, we adapted the Life-
Steps intervention to support PrEP adherence for MSM and conducted a 2-arm pilot RCT that showed high
participant acceptability, feasibility of implementation, and promise of the “Life-Steps for PrEP” adherence
intervention. Conceptual Model. The current study is to test the efficacy of a stepped-care “adaptive” Life-
Steps for PrEP adherence intervention for MSM at high-risk for HIV acquisition. Stepped care is a healthcare
delivery model in which the least resource intensive part of an intervention is delivered first, and only those
who continue to have problems receive the higher intensity, more resource intensive parts of an intervention.
The conceptual model is based on our formative work that led to the development of a theoretically-driven
intervention curriculum (“Life-Steps for PrEP”), grounded in the social and contextual realities of MSM with
multiple psychosocial problems at high-risk for HIV acquisition. Overview of Intervention. Our intervention
begins with 2-way daily text messaging aimed at enhancing optimal PrEP adherence via reminders. Although
helpful, for many MSM (~2/3 from published research), text messaging alone is not sufficient to overcome the
barriers to PrEP adherence. Those not adherent (<4 pills over a 7-day period) from text reminders, will “step
up” to receive Life-Steps adherence counseling. Research Plan. 250 HIV uninfected PrEP naïve MSM (at
least 50% racial/ethnic minority) at risk for adherence difficulties (≥1 syndemic condition) will be recruited in
two major U.S. cities with excellent access to and research experience with the population. Participants will be
equally randomized to: (1) “Life-Steps for PrEP” – a stepped care, adherence intervention with integrated
technology and counseling; or (2) Standard of care control group. Participants will be followed for 18-months
post-randomization. The primary outcomes are enhanced maintenance of PrEP adherence (DBS TFV-DP
concentrations & self-report) and retention in PrEP care; we will also examine improvements in PrEP
adherence skills and con...

## Key facts

- **NIH application ID:** 10241375
- **Project number:** 5R01MH118043-03
- **Recipient organization:** UNIVERSITY OF MIAMI CORAL GABLES
- **Principal Investigator:** KENNETH H MAYER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $761,224
- **Award type:** 5
- **Project period:** 2019-09-06 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241375

## Citation

> US National Institutes of Health, RePORTER application 10241375, Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care (5R01MH118043-03). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10241375. Licensed CC0.

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