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NCT05753683NARecruitingAccepts Healthy Volunteers

Gathering Online for Dialogue and Discussion to Enhance Social Support

RTI International

Start Date

4/7/2025

Completion Date

11/1/2027

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 up to 500 young 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.

Detailed Description

Up to 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 Criteria

Age Range: 18 years to 30 years

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

Interventions

BEHAVIORAL

mHealth-Women's CoOp

BEHAVIORAL

Virtual Group

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Conditions

Alcohol MisuseHIVSexually Transmitted InfectionsPre-exposure Prophylaxis

Locations

RTI International

Durham, North Carolina 27707

United States