# RP7 Impact

> **NIH NIH UM2** · FLORIDA STATE UNIVERSITY · 2024 · $591,848

## Abstract

Stimulant drug (e.g., crystal methamphetamine, cocaine, ecstasy, MDMA) use is a substantial public
health problem among young gay, bisexual and other men who have sex with men (YGBMSM) in the United
States (US). Stimulant use is associated with increased engagement in sexual risk behaviors and decreased
use of HIV prevention and treatment services, and as such leads to increased HIV acquisition/transmission.
There are currently no evidence-based interventions to reduce stimulant use and concurrent HIV risk among
YGBMSM; in response to this urgent need and building of over a decade of NIH-funded formative and pilot
research, the proposed hybrid type 2 effectiveness-implementation trial is designed to assess the
effectiveness and implementation strategies of Project IMPACT—a HIV status neutral, modular behavioral
intervention to reduce HIV risk in YGBMSM who use stimulants in the context of high-risk sex. The
intervention incorporates HIV risk reduction counseling (including supporting PrEP and ART use) with
behavioral activation (BA)—an evidence-based, easy to administer, cognitive behavioral approach to treat
depression that focuses on helping individuals re-engage in activities that generate feelings of enjoyment.
 Our conceptual model posits that BA will re-engage YGBMSM in pleasurable non-drug use activities
that will serve as a natural reinforcement for functional behavior, improve depressed mood when not on
stimulants by experiencing increases in pleasure, and decrease overall distress so that YGBMSM who use
stimulants can better benefit from HIV risk reduction counseling. The initial pilot trials of Project IMPACT
resulted in significant reductions in sexual risk, stimulant use and depressive symptoms.
 Research Plan Overview: By harnessing the resources, geographic and site diversity, and
multidisciplinary expertise of the Adolescent Trials Network (ATN), the current proposal aims to efficiently and
rigorously prepare Project IMPACT for rapid translation into real-world practice. Following the RE-AIM
Framework, we will test the reach and effectiveness of Project IMPACT (compared to an enhanced Standard
of Care condition) in a two-arm, multi-site and multi-format (i.e., in-person and virtual) randomized controlled
trial of 360 cisgender YGBMSM who use stimulants in the context of high-risk sex. Participants will be
followed for 12 months, and primary outcomes include number of condomless anal sex acts while not
protected by PrEP (HIV- YGBMSM) or while not virally suppressed (HIV+ YGBMSM) and stimulant use (via
urinalysis). We will also test our multi-faceted implementation strategy by assessing adoption/ accessibility
and implementation using mixed-methods assessments that describe and examine characteristics of
successful implementation (including differences by intervention delivery format). Finally, we will assess the
feasibility of maintenance and sustainment of Project IMPACT by using the well-established CEPAC-AYA
model to project its...

## Key facts

- **NIH application ID:** 10767978
- **Project number:** 5UM2HD111102-02
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Lisa B Hightow-Weidman
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $591,848
- **Award type:** 5
- **Project period:** 2023-01-25 → 2029-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10767978

## Citation

> US National Institutes of Health, RePORTER application 10767978, RP7 Impact (5UM2HD111102-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10767978. Licensed CC0.

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