A Phase 3 interventional study of AWARE in Alcohol Consumption, Alcohol Use Disorder (AUD) and Substance Use (Drugs, Alcohol), sponsored by RAND. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by RAND · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to learn if AWARE-a brief, 4-session group program based on motivational interviewing-reduces alcohol and other drug use and sexual risk behavior among young adults experiencing homelessness (ages 18-25). The study will also learn how well AWARE can be delivered in real-world drop-in center settings and what it would take to keep the program running long-term.
The main questions it aims to answer are:
Researchers will compare AWARE to services as usual at three drop-in centers in Los Angeles and Pittsburgh to see if AWARE works to better.
Participants will:
Young adults experiencing homelessness (YAEH) are disproportionately affected by alcohol and other drug (AOD) use and sexual risk behavior, yet drop-in centers serving this population have limited access to brief, evidence-based programs that address both. AWARE is a 4-session group intervention grounded in motivational interviewing (MI) that targets AOD use and sexual risk behavior among 18-25 year olds experiencing homelessness. The program integrates education, skills building, and normative feedback in an interactive group format, incorporating components shown to be effective with homeless youth and other at-risk populations: enhancing protective factors, targeting multiple risk behaviors together, using active learning techniques, reinforcing skills, and delivering information in a non-judgmental manner. Sessions address HIV/STI knowledge and partner risk evaluation (Session 1), identifying and managing triggers for sexual risk behavior (Session 2), weighing the pros and cons of substance use and building strategies to reduce harm (Session 3), and understanding how AOD use affects brain functioning and behavior (Session 4). The brief format and group delivery model were designed to fit the service realities of drop-in centers, where YAEH may engage sporadically and staff capacity is limited.
The study design is a hybrid type 1 effectiveness-implementation study in which we will test the effectiveness of AWARE on young adult health outcomes, while collecting contextual data on implementation and sustainability of the intervention. The effectiveness study will follow a group-randomized design in which young adults receiving services at three drop-in centers will either be in the intervention condition (N = 180) or a services as usual control condition (N = 180). Young adult participants will complete surveys measuring primary and secondary outcomes at baseline, and follow-up surveys at 3- and 6-months post-baseline. The group-randomized trial will have crossover conditions and groups to avoid problems of power reduction and contamination associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on where they receive services at a given time. The field period in each condition will be divided into four 22-week phases. The three drop-in centers will alternate serving as the "intervention site" or the "control site," with each center having two intervention phases and two control phases. The first 16 weeks of each phase involves delivering AWARE (intervention sites) or surveying participants at the control sites. Sixteen weeks was chosen to repeat the four-session AWARE program four times, allowing YAEH several opportunities to attend all sessions. The remaining six weeks of each phase is an inactive "wash out" period to allow for the recruitment of a new cohort and reduce the likelihood of contamination across conditions.
In addition to testing effectiveness, this study will assess how consistently and with what quality AWARE is delivered across sites and phases (implementation outcomes), and what organizational and fiscal conditions would support long-term sustainment. Fidelity to the AWARE protocol and MI will be assessed by audio recording sessions and rating them using an adherence checklist. Participant perspectives on intervention quality will be captured at the 3-month follow-up via item measuring therapeutic alliance and MI-consistent facilitator behaviors. Sustainment will be examined through interviews with policy actors and site leaders to identify barriers and facilitators to continued adoption beyond the study period.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 360 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →RAND is the lead sponsor of 115 studies on the registry; 7 are open to participants now.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback. Participants will have access to all usual care services while receiving AWARE.
Behavioral: AWARE
Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.
AWARE is a brief (four-session) group counseling intervention that uses motivational interviewing and psychoeducation to address hazardous alcohol use and sexual risk behaviors. AWARE was developed with input from young adults experiencing homelessness and service providers and has shown to be feasible, acceptable, and efficacious when delivered in young adult homeless service settings. AWARE sessions are 45-minutes in length and delivered by one to two facilitators who receive training on the AWARE protocol and motivational interviewing. AWARE sessions provide normative feedback about alcohol use, and education about sexual risk behaviors and sexually transmitted infections. AWARE is designed to be collaborative and strengths-based, helping young adults identify and plan for high-risk situations and develop effective coping strategies to reduce the likelihood of alcohol-related negative consequences and sexual risk behaviors.
Alcohol use frequency
The number of alcohol use days (any alcohol use) and the number of binge drinking days (5+ drinks) in the past 30 days
Time frame: Baseline, 3 months, and 6 months follow-up
Alcohol use quantity
The typical number of drinks consumed on drinking days, and the maximum number of drinks consumed on drinking days in the past 30 days
Time frame: Baseline, 3 months, and 6 months follow-up
Alcohol use consequences
Number of alcohol consequences in the past 30 days, assessed by the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time frame: Baseline, 3 months, and 6 months follow-up
Other drug use frequency
Number of days of other drug use besides alcohol (cannabis, stimulants, opioids, sedatives/barbiturates, hallucinogens, cigarette and vape use) in the past 30 days.
Time frame: Baseline, 3 months, and 6 months follow-up
Cannabis use quantity
Amount of flower/bud consumed (in grams) on a typical cannabis use day
Time frame: Baseline, 3 months, and 6 months follow-up
Cannabis use consequences
Number of cannabis use consequences in the past 30 days, measured by the Brief-Marijuana Consequences Questionnaire (B-MACQ)
Time frame: Baseline, 3 months, and 6 months follow-up
Substance use disorder
Probable substance use disorder, measured with the Global Appraisal of Individual Needs Short Screener (GAIN-SS)
Time frame: Baseline, 3 months, and 6 months follow-up
Number of sexual partners
Number of oral, vaginal and anal sex partners in the past 3 months. Primary and casual sex partners will be reported separately.
Time frame: Baseline, 3 months, and 6 months follow-up
Condom use
Percentage of oral, vaginal, and anal sex events in which a condom was used in the past 3 months, assessed separately for primary and casual partners
Time frame: Baseline, 3 months, and 6 months follow-up
Alcohol or other drug use during sexual activity
Frequency of alcohol or other drug use before or during sex in the past 3 months (0=Never to 4=Every time), with primary and casual partners
Time frame: Baseline, 3 months, and 6 months follow-up
Perceived importance of condom use
Importance of increasing condom use during sex, or remaining a consistent condom user, measured on a scale from 0 (not at all important) to 10 (extremely important).
Time frame: Baseline, 3 months, and 6 months follow-up
Condom use self-efficacy
Self-efficacy to use a condom correctly and consistently and to discuss condom use with partners (from "not at all sure" to "very sure"), assessed using 8-items from a scale by Brafford and Beck (1991)
Time frame: Baseline, 3 months, and 6 months follow-up
Plan to share: Yes — Qualitative data to be shared include de-identified transcripts generated from staff focus groups and interviews with policy actors. Data will be made available to researchers for secondary analysis or replication of study findings. Transcripts will be de-identified, and sites will be referred to as Site 1, Site 2, and Site 3. Quantitative data to be shared include de-identified, aggregate survey data to be made available for secondary analysis or replication of study findings. A separate ASCII (csv) data file will be created for young adult demographic and health outcomes (Aim 1), cost and cost-effectiveness data (Aim 1), participant reach and acceptability (Aim 2), AWARE fidelity ratings (Aim 2), and implementation outcomes (Aim 2).
Supporting information: Study protocol, Statistical analysis plan
Time frame: We will deposit study data in the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) repository starting 12 months after the award begins. Study protocols, metadata, and de-identified data sets that are ready for public use will be submitted semi-annually (twice per year). Clinical trial data will be shared after the clinical trial is completed. Final project data will be made available at time of manuscript publication, or within 12 months following the project end date, whichever comes first.
Access criteria: Data will be findable for the research community through the NIAAADA. The study will be findable and identifiable using unique URL links. Links to public access files will be shared in all peer-reviewed publications.
Start is estimated for Apr 2027; primary completion for Sep 2029, 29 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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