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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735784
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Joan Tucker, RAND

Tracking Information
First Submitted Date  ICMJE November 7, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE November 16, 2018
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • Substance use [ Time Frame: 12 months ]
    frequency and quantity of alcohol and drug use
  • Unprotected sex [ Time Frame: 12 months ]
    proportion of condom-unprotected sexual events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth
Official Title  ICMJE Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Substance Use
  • Unprotected Sex
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: AWARE condition
    AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.
    Intervention: Behavioral: AWARE
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2021)
276
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
400
Actual Study Completion Date  ICMJE March 23, 2021
Actual Primary Completion Date March 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03735784
Other Study ID Numbers  ICMJE R01AA025641( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Joan Tucker, RAND
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RAND
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RAND
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP