Clinical trial NCT02188797: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Sexual Risk Behavior
Keywords: homeless
young adults
substance use
HIV risk
sexual risk behavior
group motivational interviewing
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in substance use
timeFrame: baseline, 3 months
measure: Change in substance use intentions
timeFrame: baseline, 3 months
measure: Change in negative consequences from drinking
timeFrame: baseline, 3 months
measure: Change in use of drinking protective strategies
timeFrame: baseline, 3 months
measure: Change in number of different sex partners
timeFrame: baseline, 3 months
measure: Change in condom use
timeFrame: baseline, 3 months
measure: Change in substance use before or during sex
timeFrame: baseline, 3 months
measure: Change in HIV knowledge
timeFrame: baseline, 3 months
measure: Change in sex-related protective strategies
timeFrame: baseline, 3 months
measure: Change in sexual intentions
timeFrame: baseline, 3 months
measure: Change in HIV testing
timeFrame: baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: My Friend's Place
state: California
city: Venice Beach
country: United States
facility: Safe Place for Youth
state: California
Study officials:
References: