ATN 170: IMPACT
Study Summary:
Project IMPACT is designed for Young Sexual Minority Men (YSMM) who use stimulant drugs like crystal meth, MDMA, cocaine, or ecstasy/molly. The purpose of the study is to test a therapeutic model that integrates sexual risk reduction counseling paired with Behavioral Activation (BA). BA is a type of counseling that focuses on helping people re-engage in enjoyable and meaningful life activities that do not involve stimulant use. IMPACT aims to empower young men to navigate their sex lives and drug use and manage potential risks.
What is the study trying to discover?
A scalable, culturally tailored counseling model that supports healthy sexual and drug using practices with a person-centered goal of self-mastery and a shared goal of reducing new HIV infections among YSMM struggling with stimulant use.
Why is this study important?
It is important to develop culturally sensitive counseling approaches that are specifically tailored to support YSMM with their sexual and drug using experiences. Project IMPACT recognizes no matter how we party and play, we can be empowered to master our own personal health and wellbeing. As a result of this study, we aim to provide an easily accessible and culturally sensitive toolkit to community allies and medical providers to continue forward movement—as both individuals and a community—to reduce the IMPACT of HIV among YSMM struggling with stimulant use.
Who is this study for?
Cisgender young men ages 16-24 living in the US who struggle with using stimulants while having sex with other cisgender men.
Study Details:
Protocol Status:
Pending Approval
Study Purpose:
If proven successful, the IMPACT intervention will be ready for use in routine practice in a variety of settings (e.g., substance use treatment, community organizations) to further support reducing both HIV transmission and stimulant use among YSMM.
Study Design:
A two-arm, multi-site and multi-format (i.e., in-person and virtual) randomized controlled trial (RCT) comparing the IMPACT intervention to enhanced standard of care. Nationwide in-person enrollment at five ATN Site Consortium, as well as virtual participation, will be employed.
Study Population:
Cisgender young men ages 16-24 living in the US, who struggle with stimulant (crystal meth, MDMA, cocaine, or ecstasy/molly) use while having sex with other cisgender men.
Sample Size:
450 enrolled
Study Duration:
5 years
Study Intervention:
The IMPACT intervention consists of 10 sessions— two sessions focused on risk reduction, one session focused on orienting and rationale of the BA approach, six sessions integrating BA and risk reduction counseling (including PrEP or ART uptake and retention in care), and one final session on relapse prevention. Each session lasts approximately 50 minutes.
Primary Objectives:
To test the effectiveness of the IMPACT intervention to reduce 1) condomless anal sex in the context of stimulant use while not protected by PrEP (for YSMM not living with HIV) or while not virally suppressed (for YSMM living with HIV); and 2) stimulant use (based on urinalysis and self-report).
Secondary Objective:
To assess scalability of the intervention by evaluating the multi-faceted implementation strategy in terms of reach, adoption and accessibility, implementation, maintenance, and dissemination.
In development
Participating Site Consortiums
Protocol Co-Chairs
Katie Biello
kaite_biello@brown.edu
Matthew Mimiaga
mmimiaga@ph.ucla.edu
Project Director
Jennifer Olson
jennifer_olson1@brown.edu
Study Manager
Erin Ricketts
ErinRicketts@westat.com