Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Primary Purpose
Substance Use, Sexual Risk Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group MI risk reduction program
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use focused on measuring homeless, young adults, substance use, HIV risk, sexual risk behavior, group motivational interviewing
Eligibility Criteria
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
Sites / Locations
- My Friend's Place
- Safe Place for Youth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group MI risk reduction program
Usual care control
Arm Description
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.
Participant receive HIV information brochure and Community Resource Guide.
Outcomes
Primary Outcome Measures
Change in substance use
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
Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
Change in negative consequences from drinking
Change in use of drinking protective strategies
Change in number of different sex partners
Change in condom use
Change in substance use before or during sex
Change in HIV knowledge
Change in sex-related protective strategies
Change in sexual intentions
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
Self-report of being tested in lifetime, past 3 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02188797
Brief Title
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Official Title
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Sexual Risk Behavior
Keywords
homeless, young adults, substance use, HIV risk, sexual risk behavior, group motivational interviewing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group MI risk reduction program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care control
Arm Type
No Intervention
Arm Description
Participant receive HIV information brochure and Community Resource Guide.
Intervention Type
Behavioral
Intervention Name(s)
Group MI risk reduction program
Primary Outcome Measure Information:
Title
Change in substance use
Description
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
Time Frame
baseline, 3 months
Title
Change in substance use intentions
Description
Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
Time Frame
baseline, 3 months
Title
Change in negative consequences from drinking
Time Frame
baseline, 3 months
Title
Change in use of drinking protective strategies
Time Frame
baseline, 3 months
Title
Change in number of different sex partners
Time Frame
baseline, 3 months
Title
Change in condom use
Time Frame
baseline, 3 months
Title
Change in substance use before or during sex
Time Frame
baseline, 3 months
Title
Change in HIV knowledge
Time Frame
baseline, 3 months
Title
Change in sex-related protective strategies
Time Frame
baseline, 3 months
Title
Change in sexual intentions
Description
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
Time Frame
baseline, 3 months
Title
Change in HIV testing
Description
Self-report of being tested in lifetime, past 3 months
Time Frame
baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
My Friend's Place
City
Hollywood
State/Province
California
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
Learn more about this trial
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
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