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Gathering Online for Dialogue and Discussion to Enhance Social Support

Gathering Online for Dialogue and Discussion to Enhance Social Support

Recruiting
18-30 years
All
Phase N/A

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Overview

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.

Description

A total of 500 participants who are human immunodeficiency virus (HIV)-negative who engage in heavy alcohol use will be enrolled and referred to their local health departments for pre-exposure prophylaxis (PrEP). Primary biobehavioral outcomes assessed will include reduced alcohol use (self-reported and biological, including phosphatidylethanol \[PEth\]), increased PrEP uptake (self-reported and biological), and reduced sexual risk (self-reported condomless sex and impaired sex and biological testing for HIV) at 3- and 6-month follow-up.

Eligibility

Selected Inclusion Criteria:

  • 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

Selected Exclusion Criteria:

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

Study details
    Alcohol Misuse
    HIV
    Sexually Transmitted Infections
    Pre-exposure Prophylaxis

NCT05753683

RTI International

14 May 2026

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