Recruiting

mHealth App & Group Component

Sponsor:

RTI International

Code:

NCT05753683

Conditions

Alcohol Misuse

HIV

Sexually Transmitted Infections

Pre-exposure Prophylaxis

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

mHealth-Women's CoOp

Virtual Group

Study Details

Brief 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.

Conditions

Alcohol Misuse

HIV

Sexually Transmitted Infections

Pre-exposure Prophylaxis

Study ID

NCT05753683

Start date

Apr 7, 2025

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

mHealth-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.

Virtual 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.

Primary outcome measure

  • Alcohol (Biological) [ Time Frame: Baseline ]
  • Alcohol (Biological) [ Time Frame: 3-month ]
  • Alcohol (Biological) [ Time Frame: 6-month ]
  • Alcohol (Biological) [ Time Frame: Baseline ]
  • Alcohol (Biological) [ Time Frame: 3-month ]
  • Alcohol (Biological) [ Time Frame: 6-month ]
  • Alcohol (Self-Reported) [ Time Frame: Baseline ]
  • Alcohol (Self-Reported) [ Time Frame: 3-month ]
  • Alcohol (Self-Reported) [ Time Frame: 6-month ]
  • Alcohol (Self-Reported) [ Time Frame: Baseline ]
  • Alcohol (Self-Reported) [ Time Frame: 3-month ]
  • Alcohol (Self-Reported) [ Time Frame: 6-month ]
  • Sexual Risk: HIV (Biological) [ Time Frame: Baseline ]
  • Sexual Risk: HIV (Biological) [ Time Frame: 6-month ]
  • Sexual Risk (Self-reported) [ Time Frame: Baseline ]
  • Sexual Risk (Self-reported) [ Time Frame: 3-month ]
  • Sexual Risk (Self-reported) [ Time Frame: 6-month ]
  • PrEP Utilization (Biological) [ Time Frame: 3-month ]
  • PrEP Utilization (Biological) [ Time Frame: 6-month ]
  • PrEP Utilization (Self-Reported) [ Time Frame: Baseline ]
  • PrEP Utilization (Self-Reported) [ Time Frame: 3-month ]
  • PrEP Utilization (Self-Reported) [ Time Frame: 6-month ]

Central Contacts and Locations

Central contacts

Felicia A Browne, ScD, MPH

9195416596fbrowne@rti.org

Locations

RTI International

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Felicia A Browne, ScD, MPH

919-541-6596fbrowne@rti.org

More Information

Sponsor

RTI International

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RTI International on 2026-05-19.