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RECRUITING
NCT05753683
NA

Gathering Online for Dialogue and Discussion to Enhance Social Support

Sponsor: RTI International

View on ClinicalTrials.gov

Summary

The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with 500 young African American women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol. The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation. Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.

Official title: GODDESS (Gathering Online for Dialogue and Discussion to Enhance Social Support): Engaging Young African American Women in a Virtual Group App to Address Alcohol Misuse, Sexual Risk, and Pre-exposure Prophylaxis (PrEP) in North Carolina (NC)

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-04-07

Completion Date

2027-04

Last Updated

2025-06-04

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

mHealth-Women's CoOp

The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and violence through education, skills-building, and role-play and rehearsal via a mobile app. The mHealth-Women's CoOp app is also used to help participants monitor progress toward their goals throughout the study period. Specifically, the app is programmed to prompt the user, to visit the app and participate in several activities, including health and behavior check-in and revisiting aspects of the mHealth-Women's CoOp educational content to sustain risk reduction.

BEHAVIORAL

Virtual Group

The enhanced online group component will be available to be accessed using the mHealth-Women's CoOp platform for participants in the enhanced arm. The purpose of this component is to allow for young women who use alcohol to interact with young women like them and also discuss issues related to substance use and sexual risk-taking via a guided conversation to allow for motivational and informational support. The virtual group component will include online live discussions moderated and monitored by a trained online facilitator.

Locations (1)

RTI International

Durham, North Carolina, United States