Alcohol and Drug AbuseNCT01977092
Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing
A study testing Motivational interviewing case management and Resource referrals in people with Alcohol and Drug Abuse, run by Public Health Institute, California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol and Drug Abuse
- What is being tested?
- Motivational interviewing case management and Resource referrals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- serious mental health disorder that would hinder their ability to provide informed consent or otherwise participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcohol Research Group
Emeryville, California, 94608
About this study
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.
Read the 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.
- Conditions
- Alcohol and Drug Abuse
- Being tested
- Motivational interviewing case management, Resource referrals
- Keywords
- sober living houses, HIV, alcohol and drugs
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing case managementBehavioural
Resource referralsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing case management | Experimental | 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). Receives: Behavioral: Motivational interviewing case management |
| Resource referrals | Other | Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. Receives: Behavioral: Resource referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and 12 months
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).
Measured: Baseline, 6 months, and 12 months
Change in Worries About HIV in Past 6 Months.
Measured by whether or not the participant was worried about HIV in past 6 months.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol and Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Institute, California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Doug Polcin, Ed.D, Principal investigator, Alcohol Research Group / Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977092
- Sponsor's protocol ID
- 1R01DA034973-01A1
- Other IDs
- R01DA034973-01A1
- Status last verified
- Jun 2018
- First submitted
- 25 Sep 2013
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing
- ClinicalTrials.gov ID
- NCT01977092
- Acronym / sponsor ID
- 1R01DA034973-01A1
- Conditions
- Alcohol and Drug Abuse
- Keywords
- sober living houses, HIV, alcohol and drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Public Health Institute, CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing case management | Experimental | Behavioral: Motivational interviewing case managementMICM 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). |
| Resource referrals | Other | Behavioral: Resource referralsRespondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- serious mental health disorder that would hinder their ability to provide informed consent or otherwise participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing case management | Behavioural | Motivational interviewing case management |
| Resource referrals | Behavioural | Resource referrals |
Primary outcome
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.
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Polcin, Ed.D principal investigator
Alcohol Research Group / Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing case management and Resource referrals in people with Alcohol and Drug Abuse, run by Public Health Institute, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Criminal Justice Outcomes (time frame: Baseline, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.