AWARE Program for Alcohol Consumption and Unsafe Sex

Not yet recruiting at 2 trial locations
MG
Overseen ByMarylou Gilbert
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: RAND
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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:

* Does AWARE reduce the frequency, quantity, and consequences of alcohol use more than services as usual?

* Does AWARE reduce sexual risk behavior (condomless sex with primary and casual partners, number of sexual partners, and alcohol or other drug use during sexual activity)?

* How consistently and well can AWARE be delivered at community drop-in centers?

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:

* Attend up to 4 group sessions of AWARE or continue receiving usual services at their drop-in center

* Complete surveys about their alcohol and drug use, sexual behavior, and health at study enrollment, and 3 and 6 month follow-ups.

Who Is on the Research Team?

GD

Graham DiGuiseppi

Principal Investigator

RAND

AK

Ariella Korn

Principal Investigator

RAND

Are You a Good Fit for This Trial?

This trial is for young adults ages 18-25 who are experiencing homelessness and use drop-in centers in Los Angeles or Pittsburgh. Participants may have issues with alcohol, drug use, or risky sexual behaviors.

Inclusion Criteria

I am between 18 and 25 years old.
Receiving services at the drop-in center
Plans to stay in the geographic area for the next month
See 1 more

Exclusion Criteria

Observed cognitive impairment during enrollment

What Are the Treatments Tested in This Trial?

Interventions

  • AWARE

Trial Overview

The study tests AWARE, a brief group program using motivational interviewing to reduce drinking, drug use, and risky sex. Participants get either AWARE (4 sessions) or usual services at their center. Progress is tracked over 6 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: AWARE conditionExperimental Treatment1 Intervention
Group II: Standard care conditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials
145
Recruited
617,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+