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Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03735784
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 5, 2020
Information provided by (Responsible Party):
Joan Tucker, RAND

Brief Summary:
This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.

Condition or disease Intervention/treatment Phase
Substance Use Unprotected Sex Behavioral: AWARE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AWARE condition
AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.
Behavioral: AWARE
AWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies.

No Intervention: Standard Care condition
Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.

Primary Outcome Measures :
  1. Substance use [ Time Frame: 12 months ]
    frequency and quantity of alcohol and drug use

  2. Unprotected sex [ Time Frame: 12 months ]
    proportion of condom-unprotected sexual events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03735784

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United States, California
My Friend's Place Recruiting
Hollywood, California, United States, 90028
Contact: Heather Carmichael    323-908-0011   
Youth Center on Highland Recruiting
Los Angeles, California, United States, 90038
Contact: Simon Costello    323-860-2280   
Safe Place for Youth Recruiting
Venice Beach, California, United States, 90291
Contact: Alison Hurst    562-230-0540   
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joan Tucker, Senior Behavioral Scientist, RAND Identifier: NCT03735784    
Other Study ID Numbers: R01AA025641 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No