Actively Recruiting

Phase Not Applicable
Age: 18Years - 30Years
All Genders
Healthy Volunteers
ID05753683

GODDESS: Engaging Young African American Women in a Virtual Group App to Address Alcohol Misuse, Sexual Risk, and PrEP Use

Led by RTI International · Updated on 2026-05-19

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

RTI International

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

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-Women's 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

Who Can Participate

Age: 18Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Test positive for HIV
  • Participated in previous related study activities of this trial or related studies

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

RTI International

Durham, North Carolina, United States, 27707

Actively Recruiting

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Research Team

F

Felicia A Browne, ScD, MPH

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...

https://pubmed.ncbi.nlm.nih.gov/40989241