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Substance Use and Sexual Risk Reduction Intervention for 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: NCT02188797
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
RAND

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date April 19, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Change in substance use [ Time Frame: baseline, 3 months ]
    past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse
  • Change in substance use intentions [ Time Frame: baseline, 3 months ]
    Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
  • Change in negative consequences from drinking [ Time Frame: baseline, 3 months ]
  • Change in use of drinking protective strategies [ Time Frame: baseline, 3 months ]
  • Change in number of different sex partners [ Time Frame: baseline, 3 months ]
  • Change in condom use [ Time Frame: baseline, 3 months ]
  • Change in substance use before or during sex [ Time Frame: baseline, 3 months ]
  • Change in HIV knowledge [ Time Frame: baseline, 3 months ]
  • Change in sex-related protective strategies [ Time Frame: baseline, 3 months ]
  • Change in sexual intentions [ Time Frame: baseline, 3 months ]
    Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested
  • Change in HIV testing [ Time Frame: baseline, 3 months ]
    Self-report of being tested in lifetime, past 3 months
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 Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Official Title  ICMJE Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Brief Summary The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered risk reduction program for homeless young adults. It is hypothesized that youth who participate in the program will show greater reductions in substance use intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not participate in the program.
Detailed Description

This study addresses an important gap in prevention services for homeless youth by conducting a pilot test of an innovative 4-session integrated substance use and sexual risk reduction program for this population that is feasible to deliver in settings where these youth seek services. The study has 2 specific aims:

Aim 1: Investigate whether homeless youth who participate in the program show reductions in substance use and intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not receive the program.

Aim 2: Gain a better understanding of intervention effects by exploring whether improvements in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance use and offers serve as explanatory mechanisms for reductions in substance use- and sexual activity- related intentions and risk behaviors among youth who participate in the program.

The program will be evaluated using a form of group-randomized design, although with crossover of conditions and groups to avoid the problems of power reduction associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on the agency where they are seeking services. Youth at two drop-in centers serving homeless youth will either be in the intervention condition or a "usual care" control condition. The field period will be divided into four phases. The two agencies will alternate across phases in serving as the "intervention site" or "control site," with each agency having a total of two intervention phases and two control phases.

Intervention Condition: This condition involves a four-session voluntary intervention that is delivered within a drop-in center setting and is based on the investigator's previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and substance use. Although some sessions focus more heavily on sexual risk and others on substance use, each session includes content that emphasizes the interrelated nature of these two risk behaviors. In all sessions, participants will receive a personalized feedback sheet that specifically addresses a topic being discussed during that particular session. An motivational interviewing approach will be used to present material during the group sessions.

"Usual Care" Condition: The "usual care" condition reflects the resources typically available in settings that serve homeless youth: an HIV informational brochure that discusses the connection between substance use and HIV risk, and a Community Resource Guide that lists free or low-cost substance use and HIV-related services.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Substance Use
  • Sexual Risk Behavior
Intervention  ICMJE Behavioral: Group MI risk reduction program
Study Arms  ICMJE
  • Experimental: Group MI risk reduction program
    Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior. They also receive an HIV information brochure and Community Resource Guide.
    Intervention: Behavioral: Group MI risk reduction program
  • No Intervention: Usual care control
    Participant receive HIV information brochure and Community Resource Guide.
Publications * Not Provided

*   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: May 5, 2015)
200
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
168
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • between 18-24 years, receiving services at one of the participating drop-in centers, planning to be in the study area for the next month

Exclusion Criteria:

  • obvious cognitive impairment observed during screening process; non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 24 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 NCT02188797
Other Study ID Numbers  ICMJE R34DA034813( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RAND
Verification Date April 2016

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