Gathering Online for Dialogue and Discussion to Enhance Social Support

Part of paid clinical trials in Durham, North Carolina.

Sponsor
RTI International
Study ID
NCT05753683
Status
Recruiting
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Conditions

  • Alcohol Misuse
  • HIV
  • Pre-exposure Prophylaxis
  • Sexually Transmitted Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • mHealth-Women's CoOp — BEHAVIORAL
    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.
  • Virtual Group — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard: mHealth-Women's CoOp
    Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women. The app will be installed on each participant's smartphone by study staff after randomization.
  • Experimental: Enhanced: mHealth-Women's CoOp+Group
    Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.

Primary Outcome Measure

Alcohol (Biological) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RTI InternationalDurhamNorth Carolina27707
Felicia A Browne, ScD, MPH
[email protected]
919-541-6596

Find similar trials in Durham, NC

By condition
HIV
By specialty
Infectious disease
By research site
RTI International· Durham, NC

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