RecruitingNot ApplicableNCT05753683

Gathering Online for Dialogue and Discussion to Enhance Social Support

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)

Sponsor

RTI International

Enrollment

500 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Pre-exposure Prophylaxis Alcohol Misuse Sexually Transmitted Infections

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.

Eligibility

Min Age: 18 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online support group program designed to help young Black women reduce substance use and lower their risk of HIV, by connecting them with peers in a safe, virtual discussion space. **You may be eligible if...** - You identify as Black or African American - You identify as female - You are between 18 and 30 years old - You have used substances recently - You are HIV-negative and are not currently on HIV prevention medication (PrEP) - You have an Android or Apple smartphone **You may NOT be eligible if...** - You are HIV-positive - You have already participated in earlier parts of this study or related prior studies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALmHealth-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.

BEHAVIORALVirtual 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.