Clinical trial NCT05753683: Gathering Online for Dialogue and Discussion to Enhance Social Support
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Misuse
HIV
Sexually Transmitted Infections
Pre-exposure Prophylaxis
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 500 young African American 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: A total of 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: 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

Primary outcomes:
measure: Alcohol (Biological)
timeFrame: Baseline
measure: Alcohol (Biological)
timeFrame: 3-month
measure: Alcohol (Biological)
timeFrame: 6-month
measure: Alcohol (Biological)
timeFrame: Baseline
measure: Alcohol (Biological)
timeFrame: 3-month
measure: Alcohol (Biological)
timeFrame: 6-month
measure: Alcohol (Self-Reported)
timeFrame: Baseline
measure: Alcohol (Self-Reported)
timeFrame: 3-month
measure: Alcohol (Self-Reported)
timeFrame: 6-month
measure: Alcohol (Self-Reported)
timeFrame: Baseline
measure: Alcohol (Self-Reported)
timeFrame: 3-month
measure: Alcohol (Self-Reported)
timeFrame: 6-month
measure: Sexual Risk: HIV (Biological)
timeFrame: Baseline
measure: Sexual Risk: HIV (Biological)
timeFrame: 6-month
measure: Sexual Risk (Self-reported)
timeFrame: Baseline
measure: Sexual Risk (Self-reported)
timeFrame: 3-month
measure: Sexual Risk (Self-reported)
timeFrame: 6-month
measure: PrEP Utilization (Biological)
timeFrame: 3-month
measure: PrEP Utilization (Biological)
timeFrame: 6-month
measure: PrEP Utilization (Self-Reported)
timeFrame: Baseline
measure: PrEP Utilization (Self-Reported)
timeFrame: 3-month
measure: PrEP Utilization (Self-Reported)
timeFrame: 6-month
Secondary outcomes:
measure: Drug Use (Biological)
timeFrame: Baseline
measure: Drug Use (Biological)
timeFrame: 3-month
measure: Drug Use (Biological)
timeFrame: 6-month
measure: Drug Use (Self-Reported)
timeFrame: Baseline
measure: Drug Use (Self-Reported)
timeFrame: 3-month
measure: Drug Use (Self-Reported)
timeFrame: 6-month
measure: Perceived social support
timeFrame: Baseline
measure: Perceived social support
timeFrame: 3-month
measure: Perceived social support
timeFrame: 6-month
measure: Violence
timeFrame: Baseline
measure: Violence
timeFrame: 3-month
measure: Violence
timeFrame: 6-month
Other outcomes:
Locations:
city: Durham
country: United States
facility: RTI International
state: North Carolina
Study officials:
affiliation: RTI International
name: Felicia A Browne, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: