Gathering Online for Dialogue and Discussion to Enhance Social Support (GODDESS)

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)

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-, 6-, 9-, and 12-months post-enrollment.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Sexually Transmitted Infections; Alcohol Misuse; Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: mHealth-Women's CoOp; Behavioral: Virtual Group

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/sexually transmitted infections [STIs]) at 3-, 6-, 9-, and 12-month follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felicia A Browne, ScD, MPH; Phone Number: 9195416596; Email: fbrowne@rti.org

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • RTI International
      • Contact: Felicia A Browne, ScD, MPH; Phone Number: 919-541-6596; Email: fbrowne@rti.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard: mHealth-Women's CoOp; 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; The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a gender-specific human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and gender-based 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.
Experimental: Enhanced: mHealth-Women's CoOp+Group; 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; The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a gender-specific human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and gender-based 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	9-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.	12-month
Alcohol (Biological)	Phosphatidylethanol (PEth) in dried blood spots (DBS) with concentration greater than 20 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 greater than 20 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 greater than 20 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 (Biological)	Phosphatidylethanol (PEth) in dried blood spots (DBS) with concentration greater than 20 ng/mL is an indication of alcohol exposure in the last 2-4 weeks (approximately). Higher concentrations of PEth indicates higher recent alcohol consumption.	9-month
Alcohol (Biological)	Phosphatidylethanol (PEth) in dried blood spots (DBS) with concentration greater than 20 ng/mL is an indication of alcohol exposure in the last 2-4 weeks (approximately). Higher concentrations of PEth indicates higher recent alcohol consumption.	12-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)	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-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).	12-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
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.	9-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.	12-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.	12-month
Sexual Risk: Sexually Transmitted Infections (Biological)	Number of participants testing positive for Chlamydia trachomatis as assessed by a polymerase chain reaction (PCR) test (Positive Percent Agreement [PPA]: 97.4%; Negative Percent Agreement [NPA]: 97.8%); number of participants testing positive for Neisseria Gonorrhoeae as assessed by a PCR test (PPA: 97.8%; NPA: 99.1%). PCR testing will return a positive result when presence of the sexually transmitted infection's genetic code is detected. Other possible results include negative or indeterminate.	Baseline
Sexual Risk: Sexually Transmitted Infections (Biological)	Number of participants testing positive for Chlamydia trachomatis as assessed by a polymerase chain reaction (PCR) test (Positive Percent Agreement [PPA]: 97.4%; Negative Percent Agreement [NPA]: 97.8%); number of participants testing positive for Neisseria Gonorrhoeae as assessed by a PCR test (PPA: 97.8%; NPA: 99.1%). PCR testing will return a positive result when presence of the sexually transmitted infection's genetic code is detected. Other possible results include negative or indeterminate.	3-month
Sexual Risk: Sexually Transmitted Infections (Biological)	Number of participants testing positive for Chlamydia trachomatis as assessed by a polymerase chain reaction (PCR) test (Positive Percent Agreement [PPA]: 97.4%; Negative Percent Agreement [NPA]: 97.8%); number of participants testing positive for Neisseria Gonorrhoeae as assessed by a PCR test (PPA: 97.8%; NPA: 99.1%). PCR testing will return a positive result when presence of the sexually transmitted infection's genetic code is detected. Other possible results include negative or indeterminate.	6-month
Sexual Risk: Sexually Transmitted Infections (Biological)	Number of participants testing positive for Chlamydia trachomatis as assessed by a polymerase chain reaction (PCR) test (Positive Percent Agreement [PPA]: 97.4%; Negative Percent Agreement [NPA]: 97.8%); number of participants testing positive for Neisseria Gonorrhoeae as assessed by a PCR test (PPA: 97.8%; NPA: 99.1%). PCR testing will return a positive result when presence of the sexually transmitted infection's genetic code is detected. Other possible results include negative or indeterminate.	9-month
Sexual Risk: Sexually Transmitted Infections (Biological)	Number of participants testing positive for Chlamydia trachomatis as assessed by a polymerase chain reaction (PCR) test (Positive Percent Agreement [PPA]: 97.4%; Negative Percent Agreement [NPA]: 97.8%); number of participants testing positive for Neisseria Gonorrhoeae as assessed by a PCR test (PPA: 97.8%; NPA: 99.1%). PCR testing will return a positive result when presence of the sexually transmitted infection's genetic code is detected. Other possible results include negative or indeterminate.	12-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
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	9-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	12-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 (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.	9-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.	12-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
PrEP Utilization (Self-Reported)	Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use	9-month
PrEP Utilization (Self-Reported)	Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Use (Biological)	Alere iScreen®DX Multi-Drugs of Abuse Dip Test (Toxicology/TDM) 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 (300 ng/mL), methamphetamine (500 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).	Baseline
Drug Use (Biological)	Alere iScreen®DX Multi-Drugs of Abuse Dip Test (Toxicology/TDM) 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 (300 ng/mL), methamphetamine (500 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).	3-month
Drug Use (Biological)	Alere iScreen®DX Multi-Drugs of Abuse Dip Test (Toxicology/TDM) 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 (300 ng/mL), methamphetamine (500 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).	6-month
Drug Use (Biological)	Alere iScreen®DX Multi-Drugs of Abuse Dip Test (Toxicology/TDM) 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 (300 ng/mL), methamphetamine (500 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).	9-month
Drug Use (Biological)	Alere iScreen®DX Multi-Drugs of Abuse Dip Test (Toxicology/TDM) 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 (300 ng/mL), methamphetamine (500 ng/mL), ecstasy (500 ng/mL), methadone (300 ng/mL), phencyclidine (25 ng/mL), marijuana (50 ng/mL).	12-month
Drug Use (Self-Reported)	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.	Baseline
Drug Use (Self-Reported)	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.	3-month
Drug Use (Self-Reported)	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-month
Drug Use (Self-Reported)	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.	9-month
Drug Use (Self-Reported)	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.	12-month
Perceived social support	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.	Baseline
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.	3-month
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.	6-month
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.	9-month
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.	12-month
Gender-based Violence	World Health Organization (WHO) gender-based violence scale: Self-reported occurrence of emotional, physical, and sexual violence across a 13-item scale. Each item uses a 3-point response scale (1 = one, 3 = many). Items are summed, and scores range from 13 to 39. Higher scores indicate more frequent occurrences of gender-based violence.	Baseline
Gender-based Violence	World Health Organization (WHO) gender-based violence scale: Self-reported occurrence of emotional, physical, and sexual violence across a 13-item scale. Each item uses a 3-point response scale (1 = one, 3 = many). Items are summed, and scores range from 13 to 39. Higher scores indicate more frequent occurrences of gender-based violence.	3-month
Gender-based Violence	World Health Organization (WHO) gender-based violence scale: Self-reported occurrence of emotional, physical, and sexual violence across a 13-item scale. Each item uses a 3-point response scale (1 = one, 3 = many). Items are summed, and scores range from 13 to 39. Higher scores indicate more frequent occurrences of gender-based violence.	6-month
Gender-based Violence	World Health Organization (WHO) gender-based violence scale: Self-reported occurrence of emotional, physical, and sexual violence across a 13-item scale. Each item uses a 3-point response scale (1 = one, 3 = many). Items are summed, and scores range from 13 to 39. Higher scores indicate more frequent occurrences of gender-based violence.	9-month
Gender-based Violence	World Health Organization (WHO) gender-based violence scale: Self-reported occurrence of emotional, physical, and sexual violence across a 13-item scale. Each item uses a 3-point response scale (1 = one, 3 = many). Items are summed, and scores range from 13 to 39. Higher scores indicate more frequent occurrences of gender-based violence.	12-month

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Felicia A Browne, ScD, MPH, RTI International

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 0218271; R01AA030452 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No