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Recruiting NCT05753683

Gathering Online for Dialogue and Discussion to Enhance Social Support

No phase Interventional Alcohol Misuse HIV Sexually Transmitted Infections Pre-exposure Prophylaxis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mHealth-Women's CoOp, Virtual Group.
Who it may be relevant to
Registry conditions: Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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 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.

Interventions

  • Behavioral 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
  • Behavioral 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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Drug Use (Biological) [Time frame: Baseline]
  • Drug Use (Biological) [Time frame: 3-month]
  • Drug Use (Biological) [Time frame: 6-month]
  • Drug Use (Self-Reported) [Time frame: Baseline]
  • Drug Use (Self-Reported) [Time frame: 3-month]
  • Drug Use (Self-Reported) [Time frame: 6-month]
  • Perceived social support [Time frame: Baseline]
  • Perceived social support [Time frame: 3-month]
  • Perceived social support [Time frame: 6-month]
  • Violence [Time frame: Baseline]
  • Violence [Time frame: 3-month]
  • Violence [Time frame: 6-month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • RTI International — Durham

Publications

  • van der Drift IM, Browne FA, Nyamaizi AM, Wechsberg WM. "A lot of the answers come from within you as well": benefits and limitations to utilizing and adapting a virtual platform to enhance social interaction and group learning. BMC Digit Health. 2025;3(1):64. doi: 10.1186/s44247-025-00204-1. Epub 2025 Sep 22. PMID 40989241

Identifiers

NCT: NCT05753683 · 0218271 · R01AA030452

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗