Gathering Online for Dialogue and Discussion to Enhance Social Support

BEHAVIORAL

mHealth-Women's CoOp

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.

BEHAVIORAL

Virtual Group

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.

Alcohol (Biological)

Time frame: Baseline

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.

Alcohol (Biological)

Time frame: 3-month

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.

Alcohol (Biological)

Time frame: 6-month

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.

Alcohol (Biological)

Time frame: Baseline

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 (Biological)

Time frame: 3-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 (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: Baseline

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).

Alcohol (Self-Reported)

Time frame: 3-month

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).

Alcohol (Self-Reported)

Time frame: 6-month

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).

Alcohol (Self-Reported)

Time frame: Baseline

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.

Alcohol (Self-Reported)

Time frame: 3-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.

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: Baseline

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: 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: Baseline

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

Sexual Risk (Self-reported)

Time frame: 3-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

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: 3-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 (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: Baseline

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

PrEP Utilization (Self-Reported)

Time frame: 3-month

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

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.