NCT02188797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

July 10, 2014

Last Update Submit

April 15, 2016

Conditions

Keywords

homelessyoung adultssubstance useHIV risksexual risk behaviorgroup motivational interviewing

Outcome Measures

Primary Outcomes (11)

  • 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

    baseline, 3 months

  • Change in substance use intentions

    Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs

    baseline, 3 months

  • Change in negative consequences from drinking

    baseline, 3 months

  • Change in use of drinking protective strategies

    baseline, 3 months

  • Change in number of different sex partners

    baseline, 3 months

  • Change in condom use

    baseline, 3 months

  • Change in substance use before or during sex

    baseline, 3 months

  • Change in HIV knowledge

    baseline, 3 months

  • Change in sex-related protective strategies

    baseline, 3 months

  • 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

    baseline, 3 months

  • Change in HIV testing

    Self-report of being tested in lifetime, past 3 months

    baseline, 3 months

Study Arms (2)

Group MI risk reduction program

EXPERIMENTAL

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.

Behavioral: Group MI risk reduction program

Usual care control

NO INTERVENTION

Participant receive HIV information brochure and Community Resource Guide.

Interventions

Group MI risk reduction program

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • obvious cognitive impairment observed during screening process; non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

My Friend's Place

Hollywood, California, United States

Location

Safe Place for Youth

Venice Beach, California, 90291, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 14, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations