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Gathering Online for Dialogue and Discussion to Enhance Social Support

Study acronym: GODDESS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Apr 2027 to Nov 2027
    • Study description shortened, about 1 word
    v10
  2. Re-verified, no change to tracked fieldsv9
  3. Trial status: Not Yet Recruiting to Recruitingv8 Show 5 more changesShow less
    • Primary endpoints: 41 to 22
    • Start date changed from estimate of Apr 2025 to Apr 7, 2025
    • Secondary endpoints: 20 to 12
    • Site details revised
    • Study description shortened, about 5 words
  4. Start date: Feb 2025 to Apr 2025v7
  5. Start date: Dec 2024 to Feb 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Aug 2024 to Dec 2024v5
  2. Primary and study completion dates: Mar 2027 to Apr 2027v4
  3. Start date: Dec 2023 to Aug 2024v3
  4. Start date: Jul 2023 to Dec 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05753683
Lead Sponsor RTI International
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis
Related terms Sexually Transmitted Diseases
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov