Gathering Online for Dialogue and Discussion to Enhance Social Support

Not Applicable

Recruiting

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

• Registration Number: NCT05753683
• Lead Sponsor: RTI International

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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-03
• Study Start: 2025-04-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alcohol (Biological)	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)	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)	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)	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)	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)	6-month	Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use

Secondary Outcome Measures

Name	Time	Method
Drug Use (Biological)	6-month	Easy@Home Multi-Drug Screen Test: Rapid urine-based drug screen to detect metabolites of recent drug use (\>99% correlation to gas chromatography at 95% confidence level) 10-panel-amphetamine, benzodiazepines, barbiturates, cocaine, opiates, methamphetamine, ecstasy, methadone, phencyclidine, and marijuana. Each test has a control line region to serve as a procedural control and a test line region; results with only a line in the control region and without a line in the test region are classified as positive. Concentrations at or above the following cutoff concentrations indicate a positive result for the following substances: amphetamine (1000 ng/mL), benzodiazepines (300 ng/mL), barbiturates (300 ng/mL), cocaine (300 ng/mL), opiates (2000 ng/mL), methamphetamine (1000 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).
Drug Use (Self-Reported)	6-month	The World Health Organization's Alcohol, Smoking \& Substance Use Involvement Scale (ASSIST) assesses risk for problems with drugs-such as marijuana, cocaine, amphetamine, and opioids-via 8 items. Scores range from 0 to 39, and this score indicates level of risk for drug use problems. Scores from 0 to 3 indicate lower risk for drug use problems, scores from 4 to 26 indicate moderate risk, and scores from 27 to 39 indicate high risk.
Perceived social support	6-month	Multidimensional Scale of Perceived Social Support assesses perceived social support from family, friends, and others across a 12-item scale. Each item uses a 7-point scale (1 = very strongly disagree, 7 = very strongly agree). Items are summed and the total score is divided by the number of items. Scores range from 0 to 7. Higher scores indicate higher levels of social support.
Violence	6-month	Adaptation of the World Health Organization (WHO) violence scale: Self-reported occurrence of emotional, physical, and sexual violence with an additional financial abuse query, all combined into a 16-item scale. Each item uses a 3-point response scale (1 = Never, 2 = Sometimes, 3 = Frequently). Items are summed, and scores range from 16 to 48. Higher scores indicate more frequent occurrences of violence.

Trial Locations

Locations (1)

RTI International; 🇺🇸 Durham, North Carolina, United States