# Comparative effectiveness trial of clinic-based delivery of an HIV risk reduction intervention for YMSM

> **NIH NIH U19** · FLORIDA STATE UNIVERSITY · 2020 · $270,606

## Abstract

Young men who have sex with men (YMSM) remain a critical population in need of empirically supported
approaches to improve self-management to promote reduced HIV sexual risk behaviors and substance use.
The Young Men’s Health Project (YMHP), a structured and manualized 4-session intervention utilizing
motivational interviewing, personalized feedback, and problem-solving skills building approaches for HIV-negative
or untested youth was found to be efficacious in significantly reducing substance use and condomless
anal sex (CAS) among YMSM ages 18-29. To date, this is the first and only RCT of any published trial or CDC
DEBI with YMSM to show significant reductions in both substance use and sexual risk. The CDC recently rated
YMHP as “Best Evidence” and placed it on the compendium of Evidence Based Interventions and Best
Practices for HIV Prevention. YMHP was tested through an efficacy trial in a research center environment with
numerous inclusion and exclusion criteria, and thus, a real-world-based replication is the crucial next step in
studying the intervention’s effectiveness in the real world when delivered by front-line staff to their clients. We
will conduct a comparative effectiveness trial (CET) with two modalities of YMHP delivery – clinic-based and
telephone-based — at three HIV clinic sites in Los Angeles, Philadelphia, and Miami. The Specific Aims are to:
1) adapt the YMHP intervention for clinic and phone delivery in HIV clinics by community health workers
(CHWs); 2) compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the context of
health care access, assessing the cost effectiveness of both modalities and the five components of the selfmanagement
model; and 3) test a sustainable model of YMHP implementation in real-world adolescent HIV
clinics. The proposed study will be implemented over two phases. In Phase 1 we will conduct qualitative
research with staff at our collaborating clinics (to understand implementation issues) and YMSM ages 15-17 (to
adapt the efficacious YMHP intervention to be developmentally appropriate). In Phase 2 we will randomize 270
YMSM ages 15-24, to receive YMHP by phone or in person at the clinic. Assessments will include behavioral
self-report measures, urine testing for substance use, and STI testing for sexual health outcomes. Working
together with our clinic collaborators will help to address practical problems at the frontline of service provision
to pave the way for a comprehensive program to reduce HIV infection among YMSM. If effective, our program
has the potential to exert a sustained and powerful influence on the effectiveness of behavioral interventions
for YMSM.

## Key facts

- **NIH application ID:** 9980431
- **Project number:** 5U19HD089875-06
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Tyrel J Starks
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $270,606
- **Award type:** 5
- **Project period:** — → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980431

## Citation

> US National Institutes of Health, RePORTER application 9980431, Comparative effectiveness trial of clinic-based delivery of an HIV risk reduction intervention for YMSM (5U19HD089875-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9980431. Licensed CC0.

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