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NCT Number: NCT05753683

Gathering Online for Dialogue and Discussion to Enhance Social Support

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 up to 500 young 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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RTI International

Durham, North Carolina, 27707, United States

Location status: Recruiting

Location contact

Felicia A Browne, ScD, MPH

CONTACT

[email protected]

919-541-6596

About this study

Up to 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Selected 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. PrEP Utilization (Self-Reported)

    Time frame: Baseline

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

  21. 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

  22. 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

  1. Drug Use (Biological)

    Time frame: Baseline

    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).

  2. Drug Use (Biological)

    Time frame: 3-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).

  3. Drug Use (Biological)

    Time frame: 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).

  4. Drug Use (Self-Reported)

    Time frame: Baseline

    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.

  5. Drug Use (Self-Reported)

    Time frame: 3-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.

  6. Drug Use (Self-Reported)

    Time frame: 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.

  7. Perceived social support

    Time frame: Baseline

    Multidimensional Scale of Perceived Social Support assesses perceived social support 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.

  8. Perceived social support

    Time frame: 3-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.

  9. Perceived social support

    Time frame: 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.

  10. Violence

    Time frame: Baseline

    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.

  11. Violence

    Time frame: 3-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.

  12. Violence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Felicia A Browne, ScD, MPH

CONTACT

[email protected]

9195416596

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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)

Acronym: GODDESS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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