Virtual Group Support With mHealth App to Reduce Alcohol Use and Sexual Risk in Young Black Women
A Study to Increase PrEP Use and Decrease HIV Risk in African American Women Ages 18 to 30
Led by RTI International · Updated on 2026-05-19
500
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate a modified mobile health mHealth intervention with a virtual group component compared to a standard mHealth intervention among young women who are HIV-negative and misuse alcohol. The study focuses on reducing alcohol use and sexual risk, and increasing pre-exposure prophylaxis PrEP use. Up to 500 participants will be enrolled in this two-arm randomized trial sponsored by RTI International.
Participants will be randomly assigned to one of two groups one will receive the mHealth-Womens CoOp app, an educational and skills-building program addressing substance use, sexual risk, and violence through a mobile app. The other group will receive the same app plus access to a virtual peer group component, which offers live, moderated discussions to support motivation and information sharing. The app will be installed on participants smartphones after randomization.
Participants will be followed for 6 months, with assessments at baseline, 3 months, and 6 months. Researchers will measure alcohol use through self-reports and biological tests, sexual risk behaviors, and PrEP uptake using both self-reports and biological markers. Additional assessments include drug use, perceived social support, and experiences of violence. The study includes regular follow-ups to monitor outcomes and support participant engagement throughout the trial.
CONDITIONS
Brief Title
Gathering Online for Dialogue and Discussion to Enhance Social Support
Research Team
F
Felicia A Browne, ScD, MPH
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
App‑Only Intervention
App‑Plus‑Group Intervention
What the interventions are
A mobile app–based HIV risk‑reduction program (“mHealth‑Women’s CoOp”) focused on alcohol misuse, sexual risk, and goal tracking.
The same app plus a live online moderated group component for peer discussion and support.
Role in the trial
Randomized standard comparator arm delivering the mHealth intervention alone.
Experimental arm testing whether adding group interaction improves outcomes.
Primary use or goal
Reduce alcohol‑related risk and sexual risk behaviors through self‑guided app.
Same self‑guided app plus facilitated group discussion to enhance social support while reducing risks.
How delivered
Access content and goal‑tracking through the mobile app on Android or iOS.
Same app usage plus scheduled live online group sessions moderated by facilitator.
Evidence and prior support
Based on a previously tested Women’s CoOp intervention adapted to mobile delivery, with proven efficacy in face‑to‑face formats.
The added virtual group component is novel; its added benefit over the app alone has not yet been established.
Important limitations
The app‑only format may offer less social support than group formats which could limit engagement.
Virtual group sessions require scheduling and internet connectivity, which may affect accessibility.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 30Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Identify as Black or African American
Identify as female
Be between 18 and 30 years old
Recent substance use
HIV negative and not currently on PrEP
Have an Android or iOS smartphone
You will not qualify if you...
Test positive for HIV
Participated in previous related study activities of this trial or related studies
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Treatment
Duration - 6 months
Participants use the mHealth-Women's CoOp app, with some participants also joining virtual group discussions to support reduction of alcohol use and sexual risk behaviors.
Regular app use with 3 assessment visits at baseline, 3 months, and 6 months
Follow-up
Duration - Up to 6 months after treatment start
Participants are followed up to assess behavioral and biological outcomes related to alcohol use, sexual risk, and PrEP uptake.
3 visits at baseline, 3 months, and 6 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
"A lot of the answers come from within you as well": benefits and limitations to utilizing and adapting a virtual platform to enhance social interaction and group learning.
Isa M van der Drift, Felicia A Browne, Alinda M Nyamaizi...