Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth

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

Tracking Information

• First Submitted Date: November 7, 2018
• First Posted Date: November 8, 2018
• Last Update Posted Date: June 21, 2021
• Actual Study Start Date: November 16, 2018
• Actual Primary Completion Date: March 23, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention

Condition

• Substance Use
• Unprotected Sex

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2021): 276
• Original Estimated Enrollment (submitted: November 7, 2018): 400
• Actual Study Completion Date: March 23, 2021
• Actual Primary Completion Date: March 23, 2021 (Final data collection date for primary outcome measure)

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:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03735784
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Joan Tucker, RAND
• Original Responsible Party: Same as current
• Current Study Sponsor: RAND
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RAND
• Verification Date: June 2021