Gathering Online for Dialogue and Discussion to Enhance Social Support
This study is testing a mobile health (mHealth) program called mHealth-Women's CoOp, which helps reduce risks related to substance use, sexual health, and violence. It also includes an optional online group component where young women can connect and discuss shared experiences. The goal is to see if adding this virtual group helps reduce alcohol use and risky sexual behaviors, and increases the use of PrEP (pre-exposure prophylaxis, a medication to prevent HIV). You might be able to join if you are a Black/African American woman between 18 and 30, use substances, are HIV-negative and not currently on PrEP, and have a smartphone. The study aims to enroll up to 500 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study that will randomly assign up to 500 participants to either receive the mHealth-Women's CoOp app alone or the app plus the virtual group component.
- What's involved
- Participants will be followed up at 3 and 6 months after joining the study to assess alcohol use, PrEP uptake, and sexual risk.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gathering Online for Dialogue and Discussion to Enhance Social Support
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Felicia A Browne, ScD, MPH · PRINCIPAL_INVESTIGATOR · RTI International
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Alcohol (Biological)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)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)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)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)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)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)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)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)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)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)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)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)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)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)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)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)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)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)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)Baseline
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
- PrEP Utilization (Self-Reported)3-month
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
- PrEP Utilization (Self-Reported)6-month
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use