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

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

Inclusion Criteria6

  • identify as Black/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-based smartphone

Exclusion Criteria2

  • test positive for HIV
  • participated in the previous study activities of the current study or previous related studies

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.


Locations(1)

RTI International

Durham, North Carolina, United States

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NCT05753683


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