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

Primary Purpose

Alcohol Misuse, HIV, Sexually Transmitted Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth-Women's CoOp
Virtual Group
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Misuse

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RTI International

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard: mHealth-Women's CoOp

Enhanced: mHealth-Women's CoOp+Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 6, 2023
Last Updated
May 18, 2023
Sponsor
RTI International
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05753683
Brief Title
Gathering Online for Dialogue and Discussion to Enhance Social Support
Acronym
GODDESS
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard: mHealth-Women's CoOp
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced: mHealth-Women's CoOp+Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mHealth-Women's CoOp
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Group
Intervention Description
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 Outcome Measure Information:
Title
Alcohol (Biological)
Description
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.
Time Frame
Baseline
Title
Alcohol (Biological)
Description
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.
Time Frame
3-month
Title
Alcohol (Biological)
Description
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.
Time Frame
6-month
Title
Alcohol (Biological)
Description
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.
Time Frame
9-month
Title
Alcohol (Biological)
Description
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.
Time Frame
12-month
Title
Alcohol (Biological)
Description
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.
Time Frame
Baseline
Title
Alcohol (Biological)
Description
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.
Time Frame
3-month
Title
Alcohol (Biological)
Description
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.
Time Frame
6-month
Title
Alcohol (Biological)
Description
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.
Time Frame
9-month
Title
Alcohol (Biological)
Description
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.
Time Frame
12-month
Title
Alcohol (Self-Reported)
Description
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).
Time Frame
Baseline
Title
Alcohol (Self-Reported)
Description
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).
Time Frame
3-month
Title
Alcohol (Self-Reported)
Description
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).
Time Frame
6-month
Title
Alcohol (Self-Reported)
Description
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).
Time Frame
9-month
Title
Alcohol (Self-Reported)
Description
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).
Time Frame
12-month
Title
Alcohol (Self-Reported)
Description
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.
Time Frame
Baseline
Title
Alcohol (Self-Reported)
Description
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.
Time Frame
3-month
Title
Alcohol (Self-Reported)
Description
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.
Time Frame
6-month
Title
Alcohol (Self-Reported)
Description
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.
Time Frame
9-month
Title
Alcohol (Self-Reported)
Description
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.
Time Frame
12-month
Title
Sexual Risk: HIV (Biological)
Description
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.
Time Frame
Baseline
Title
Sexual Risk: HIV (Biological)
Description
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.
Time Frame
12-month
Title
Sexual Risk: Sexually Transmitted Infections (Biological)
Description
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.
Time Frame
Baseline
Title
Sexual Risk: Sexually Transmitted Infections (Biological)
Description
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.
Time Frame
3-month
Title
Sexual Risk: Sexually Transmitted Infections (Biological)
Description
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.
Time Frame
6-month
Title
Sexual Risk: Sexually Transmitted Infections (Biological)
Description
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.
Time Frame
9-month
Title
Sexual Risk: Sexually Transmitted Infections (Biological)
Description
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.
Time Frame
12-month
Title
Sexual Risk (Self-reported)
Description
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
Time Frame
Baseline
Title
Sexual Risk (Self-reported)
Description
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
Time Frame
3-month
Title
Sexual Risk (Self-reported)
Description
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
Time Frame
6-month
Title
Sexual Risk (Self-reported)
Description
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
Time Frame
9-month
Title
Sexual Risk (Self-reported)
Description
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
Time Frame
12-month
Title
PrEP Utilization (Biological)
Description
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.
Time Frame
3-month
Title
PrEP Utilization (Biological)
Description
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.
Time Frame
6-month
Title
PrEP Utilization (Biological)
Description
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.
Time Frame
9-month
Title
PrEP Utilization (Biological)
Description
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.
Time Frame
12-month
Title
PrEP Utilization (Self-Reported)
Description
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Time Frame
Baseline
Title
PrEP Utilization (Self-Reported)
Description
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Time Frame
3-month
Title
PrEP Utilization (Self-Reported)
Description
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Time Frame
6-month
Title
PrEP Utilization (Self-Reported)
Description
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Time Frame
9-month
Title
PrEP Utilization (Self-Reported)
Description
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Drug Use (Biological)
Description
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).
Time Frame
Baseline
Title
Drug Use (Biological)
Description
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).
Time Frame
3-month
Title
Drug Use (Biological)
Description
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).
Time Frame
6-month
Title
Drug Use (Biological)
Description
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).
Time Frame
9-month
Title
Drug Use (Biological)
Description
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).
Time Frame
12-month
Title
Drug Use (Self-Reported)
Description
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.
Time Frame
Baseline
Title
Drug Use (Self-Reported)
Description
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.
Time Frame
3-month
Title
Drug Use (Self-Reported)
Description
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.
Time Frame
6-month
Title
Drug Use (Self-Reported)
Description
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.
Time Frame
9-month
Title
Drug Use (Self-Reported)
Description
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.
Time Frame
12-month
Title
Perceived social support
Description
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.
Time Frame
Baseline
Title
Perceived social support
Description
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.
Time Frame
3-month
Title
Perceived social support
Description
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.
Time Frame
6-month
Title
Perceived social support
Description
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.
Time Frame
9-month
Title
Perceived social support
Description
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.
Time Frame
12-month
Title
Gender-based Violence
Description
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.
Time Frame
Baseline
Title
Gender-based Violence
Description
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.
Time Frame
3-month
Title
Gender-based Violence
Description
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.
Time Frame
6-month
Title
Gender-based Violence
Description
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.
Time Frame
9-month
Title
Gender-based Violence
Description
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.
Time Frame
12-month

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Identify as female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia A Browne, ScD, MPH
Phone
9195416596
Email
fbrowne@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicia A Browne, ScD, MPH
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI International
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicia A Browne, ScD, MPH
Phone
919-541-6596
Email
fbrowne@rti.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

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