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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01977092
Other study ID # 1R01DA034973-01A1
Secondary ID R01DA034973-01A1
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date July 2017

Study information

Verified date June 2018
Source Public Health Institute, California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to see if a Motivational Interviewing Case Management (MICM) intervention will improve outcomes for respondents who are on probation or parole, at risk for HIV and have recently entered a Sober Living House. The MICM will help respondents access needed services, adapt to their new living environment, find and maintain work, address HIV risk and treatment, and manage setbacks. The risk for HIV infection among criminal justice offenders is significant, as is the need for stable, drug free housing in this population. Our aim is to see if the MICM intervention in the context of drug free housing will improve health outcomes and reduce recidivism.


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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interviewing case management

Resource referrals


Locations

Country Name City State
United States Alcohol Research Group Emeryville California

Sponsors (2)

Lead Sponsor Collaborator
Public Health Institute, California National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Criminal Justice Outcomes 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
Primary Change in Alcohol and Drug Use (Timeline Follow Back) 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
Primary Change in Worries About HIV in Past 6 Months. Measured by whether or not the participant was worried about HIV in past 6 months. Baseline, 6 months, and 12 months

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