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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alcohol Misuse
- Sponsor
- RTI International
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Alcohol (Biological)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Felicia A. Browne, ScD, MPH
Senior Research Social Epidemiologist
RTI International
Eligibility Criteria
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
Exclusion Criteria
- •test positive for HIV
- •participated in the previous study activities of the current study or previous related studies
Outcomes
Primary Outcomes
Alcohol (Biological)
Time Frame: 6-month
Phosphatidylethanol (PEth) in dried blood spots (DBS) with concentration equal to or greater than 8 ng/mL is an indication of alcohol exposure in the last 2-4 weeks (approximately). Higher concentrations of PEth indicates higher recent alcohol consumption.
Alcohol (Self-Reported)
Time Frame: 6-month
World Health Organization's Alcohol, Smoking \& Substance Use Involvement Scale (ASSIST) assesses risk for alcohol consumption problems via 8 items. Scores range from 0 to 39, and this score indicates level of risk for alcohol consumption problems. Scores from 0 to 10 indicate lower risk for alcohol problems, scores from 11 to 26 indicate moderate risk, and scores from 27 to 39 indicate high risk.
Sexual Risk: HIV (Biological)
Time Frame: 6-month
Number of participants living with HIV as assessed by OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test with oral fluid, with an approximate 99.3% sensitivity \& 99.8% specificity, which detects antibodies to HIV-1 and HIV-2.
Sexual Risk (Self-reported)
Time Frame: 6-month
Revised Risk Behavior Assessment (RRBA): Condomless vaginal or anal sex, impaired sex (AOD use prior to or during sex), casual partners, sex trading, \& concurrent partners (≥2 partners), other contraceptive use, \& perception of risk, HIV, recent STIs
PrEP Utilization (Biological)
Time Frame: 6-month
Dried blood spot (DBS) samples will be analyzed by quantification of drug concentrations by liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology using assays validated at the study laboratory.
PrEP Utilization (Self-Reported)
Time Frame: 6-month
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Secondary Outcomes
- Drug Use (Biological)(6-month)
- Drug Use (Self-Reported)(6-month)
- Perceived social support(6-month)
- Violence(6-month)