- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977092
Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is based on the premise that probationers and parolees must have access to stable, drug-free housing to reduce HIV risk, access needed services and avoid rearrests and reincarceration. Drug-free housing at the Sober Living Network (SLN) in California are being studied as a way to provide a positive living environment for probationers and parolees. The houses use a sober living house (SLH) model of recovery that includes a communal recovery environment, abstinence from drugs and alcohol, peer support, and encouragement to attend self-help groups such as Alcoholics Anonymous.
The proposed study will improve SLHs for offenders by adding a Motivational Interviewing Case Management (MICM) intervention specifically targeted to the problems presented by each offender. The list of potential problems that MICM can address is extensive: 1) adapting to the SLH environment, 2) complying with parole and probation, 3) finding and maintain work, 4) successfully accessing and maintaining retention in services, 5) addressing HIV risk, testing and treatment, 6) mobilizing personal and informal resources, and 7) managing setbacks (e.g., relapse, loss of housing, loss of work).
Men and women involved with the criminal justice system (N=330) entering SLHs will be assigned to a condition consisting of a provision of a resources manual where residents can seek help for a variety of problems (a control group) or the MICM (intervention).To avoid mixing individuals who receive the intervention with individuals who do not within the same house, houses are randomized at the house level. Once a house is randomized to a study condition, all of the individuals recruited from that house receive the same intervention, MICM or SLH as usual. To avoid contamination of study conditions by gender, randomization procedures are stratified by houses for men, women, and both genders. Research interviews are conducted at baseline (within one month of entering the houses), 6 months, and 12 months. Follow-up interviews are conducted whether or not the participant leaves the SLH and at a site that is the most comfortable for the participant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Emeryville, California, United States, 94608
- Alcohol Research Group
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 18 years or older
- Speak English
- Entered the sober living house in the last month
- Able to provide contact info for followups
- Willing to attend MICM sessions
- On probation or parole
- ONE of the following: tested positive for HIV, injected drugs, sex work history, men who have sex with men (MSM), or women who have had unprotected sex in the last month with multiple partners
Exclusion Criteria:
- serious mental health disorder that would hinder their ability to provide informed consent or otherwise participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational interviewing case management
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems.
Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study.
Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
|
|
Other: Resource referrals
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Criminal Justice Outcomes
Time Frame: Baseline, 6 months, and 12 months
|
Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56
follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison.
See participant flow for number of participants in prison.
|
Baseline, 6 months, and 12 months
|
Change in Alcohol and Drug Use (Timeline Follow Back)
Time Frame: Baseline, 6 months, and 12 months
|
Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB).
|
Baseline, 6 months, and 12 months
|
Change in Worries About HIV in Past 6 Months.
Time Frame: Baseline, 6 months, and 12 months
|
Measured by whether or not the participant was worried about HIV in past 6 months.
|
Baseline, 6 months, and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Doug Polcin, Ed.D, Alcohol Research Group / Public Health Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
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
- 1R01DA034973-01A1 (U.S. NIH Grant/Contract)
- R01DA034973-01A1 (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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