Gathering Online for Dialogue and Discussion to Enhance Social Support (GODDESS)

RTI International

Status: Enrolling

Conditions: Pre-exposure Prophylaxis; Sexually Transmitted Infections; Alcohol Misuse; HIV

Treatments: Behavioral: mHealth-Women's CoOp; Behavioral: Virtual Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05753683

0218271

R01AA030452 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

Standard: mHealth-Women's CoOp

Active Comparator group

Description:

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American women. The app will be installed on each participant's smartphone by study staff after randomization.

Treatment:

Behavioral: mHealth-Women's CoOp

Enhanced: mHealth-Women's CoOp+Group

Experimental group

Description:

Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young African American 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.

Treatment:

Behavioral: Virtual Group

Behavioral: mHealth-Women's CoOp