Gathering Online for Dialogue and Discussion to Enhance Social Support

NCT05753683 | Recruiting DMC

• 2 other identifiers: 0218271R01AA030452
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (22)

• Alcohol (Biological)

  Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. The One Step Ethyl Glucuronide (EtG) Test Dip Card is a lateral flow chromatographic immunoassay. 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. Urine EtG ≥300 ng/mL indicates a positive result.

  Baseline

• Alcohol (Biological)

  Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. The One Step Ethyl Glucuronide (EtG) Test Dip Card is a lateral flow chromatographic immunoassay. 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. Urine EtG ≥300 ng/mL indicates a positive result.

  3-month

• Alcohol (Biological)

  Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. The One Step Ethyl Glucuronide (EtG) Test Dip Card is a lateral flow chromatographic immunoassay. 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. Urine EtG ≥300 ng/mL indicates a positive result.

  6-month

• Alcohol (Biological)

  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.

  Baseline

• Alcohol (Biological)

  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.

  3-month

• Alcohol (Biological)

  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.

  6-month

• Alcohol (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Volume (grams of ethanol, accounting for different standard drink size), frequency of use, frequency of binge, heavy episodic drinking (4+ drinks/day).

  Baseline

• Alcohol (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Volume (grams of ethanol, accounting for different standard drink size), frequency of use, frequency of binge, heavy episodic drinking (4+ drinks/day).

  3-month

• Alcohol (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Volume (grams of ethanol, accounting for different standard drink size), frequency of use, frequency of binge, heavy episodic drinking (4+ drinks/day).

  6-month

• Alcohol (Self-Reported)

  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.

  Baseline

• Alcohol (Self-Reported)

  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.

  3-month

• Alcohol (Self-Reported)

  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.

  6-month

• Sexual Risk: HIV (Biological)

  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.

  Baseline

• Sexual Risk: HIV (Biological)

  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.

  6-month

• Sexual Risk (Self-reported)

  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

  Baseline

• Sexual Risk (Self-reported)

  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

  3-month

• Sexual Risk (Self-reported)

  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

  6-month

• PrEP Utilization (Biological)

  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.

  3-month

• PrEP Utilization (Biological)

  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.

  6-month

• PrEP Utilization (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use

  Baseline

• PrEP Utilization (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use

  3-month

• PrEP Utilization (Self-Reported)

  Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use

  6-month

Secondary Outcomes (12)

• Drug Use (Biological)

  Baseline

• Drug Use (Biological)

  3-month

• Drug Use (Biological)

  6-month

• Drug Use (Self-Reported)

  Baseline

• Drug Use (Self-Reported)

  3-month

Study Arms (2)

Standard: mHealth-Women's CoOp

ACTIVE COMPARATOR

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.

Behavioral: mHealth-Women's CoOp

Enhanced: mHealth-Women's CoOp+Group

EXPERIMENTAL

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.

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

Interventions

mHealth-Women's CoOp BEHAVIORAL

The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and violence through education, skills-building, and role-play and rehearsal via a mobile app. The mHealth-Women's CoOp app is also used to help participants monitor progress toward their goals throughout the study period. Specifically, the app is programmed to prompt the user, to visit the app and participate in several activities, including health and behavior check-in and revisiting aspects of the mHealth-Women's CoOp educational content to sustain risk reduction.

Enhanced: mHealth-Women's CoOp+Group; Standard: mHealth-Women's CoOp

Virtual Group BEHAVIORAL

The enhanced online group component will be available to be accessed using the mHealth-Women's CoOp platform for participants in the enhanced arm. The purpose of this component is to allow for young women who use alcohol to interact with young women like them and also discuss issues related to substance use and sexual risk-taking via a guided conversation to allow for motivational and informational support. The virtual group component will include online live discussions moderated and monitored by a trained online facilitator.

Enhanced: mHealth-Women's CoOp+Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Identify as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• test positive for HIV
• participated in the previous study activities of the current study or previous related studies

Sponsors & Collaborators

• RTI International: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

RTI International

Durham, North Carolina, 27707, United States

RECRUITING

Related Publications (1)

• van der Drift IM, Browne FA, Nyamaizi AM, Wechsberg WM. "A lot of the answers come from within you as well": benefits and limitations to utilizing and adapting a virtual platform to enhance social interaction and group learning. BMC Digit Health. 2025;3(1):64. doi: 10.1186/s44247-025-00204-1. Epub 2025 Sep 22.

  PMID: 40989241 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felicia A Browne, ScD, MPH

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felicia A Browne, ScD, MPH

CONTACT

9195416596; fbrowne@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Social Epidemiologist

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: March 3, 2023
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)