Back to resultsIntervention for Substance Use and Sexual Risk Behavior in Homeless Youth
Primary Purpose
Substance Use, Unprotected Sex
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWARE
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use
Eligibility Criteria
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:
-
Sites / Locations
- My Friend's Place
- Youth Center on Highland
- Safe Place for Youth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AWARE condition
Standard Care condition
Arm Description
AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.
Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.
Outcomes
Primary Outcome Measures
Substance use
frequency and quantity of alcohol and drug use
Unprotected sex
proportion of condom-unprotected sexual events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03735784
Brief Title
Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth
Official Title
Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Unprotected Sex
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AWARE condition
Arm Type
Experimental
Arm Description
AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.
Arm Title
Standard Care condition
Arm Type
No Intervention
Arm Description
Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.
Intervention Type
Behavioral
Intervention Name(s)
AWARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance use
Description
frequency and quantity of alcohol and drug use
Time Frame
12 months
Title
Unprotected sex
Description
proportion of condom-unprotected sexual events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Facility Information:
Facility Name
My Friend's Place
City
Hollywood
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Youth Center on Highland
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Facility Name
Safe Place for Youth
City
Venice Beach
State/Province
California
ZIP/Postal Code
90291
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32723349
Citation
Tucker JS, D'Amico EJ, Pedersen ER, Rodriguez A, Garvey R. Study protocol for a group-based motivational interviewing brief intervention to reduce substance use and sexual risk behavior among young adults experiencing homelessness. Addict Sci Clin Pract. 2020 Jul 28;15(1):26. doi: 10.1186/s13722-020-00201-x.
Results Reference
derived
Learn more about this trial
Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth
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