- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188797
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Hollywood, California, United States
- My Friend's Place
-
Venice Beach, California, United States, 90291
- Safe Place for Youth
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
No Intervention: Usual care control
Participant receive HIV information brochure and Community Resource Guide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, 3 months
|
Change in substance use intentions
Time Frame: baseline, 3 months
|
Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
|
baseline, 3 months
|
Change in negative consequences from drinking
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in use of drinking protective strategies
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in number of different sex partners
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in condom use
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in substance use before or during sex
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in HIV knowledge
Time Frame: baseline, 3 months
|
baseline, 3 months
|
|
Change in sex-related protective strategies
Time Frame: baseline, 3 months
|
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
|
baseline, 3 months
|
Change in HIV testing
Time Frame: baseline, 3 months
|
Self-report of being tested in lifetime, past 3 months
|
baseline, 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34DA034813 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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