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Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing

Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977092
Enrollment
330
Registered
2013-11-06
Start date
2014-01-31
Completion date
2017-07-31
Last updated
2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol and Drug Abuse

Keywords

sober living houses, HIV, alcohol and drugs

Brief 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.

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.

Interventions

BEHAVIORALMotivational interviewing case management
BEHAVIORALResource referrals

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Public Health Institute, California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Criminal Justice OutcomesBaseline, 6 months, and 12 monthsMeasured 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)Baseline, 6 months, and 12 monthsMeasured 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.Baseline, 6 months, and 12 monthsMeasured by whether or not the participant was worried about HIV in past 6 months.

Countries

United States

Participant flow

Recruitment details

The recruitment of 330 study participants followed a two-step process: first we recruited the house, and then we recruited residents that moved in to those houses. The approximately 50 SLHs participating in the study were located in the Los Angeles area and all were members of the Sober Living Network.

Pre-assignment details

To avoid mixing individuals who received the intervention with individuals who did not within the same house, we randomized at the house level. Once a house was randomized to a study condition, all of the individuals recruited from that house received the same intervention.

Participants by arm

ArmCount
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). Motivational interviewing case management
149
Control - Resource Referrals
Respondents will receive sober living house services as usual along with a list of resources that can be used to address a variety of problems. control - Resource referrals
181
Total330

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath34
Overall StudyIn prison311
Overall StudyLost to Follow-up2314
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicMotivational Interviewing Case ManagementControl - Resource ReferralsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants4 Participants
Age, Categorical
Between 18 and 65 years
147 Participants179 Participants326 Participants
Age, Continuous38.1 years
STANDARD_DEVIATION 11.9
39.3 years
STANDARD_DEVIATION 11.6
38.1 years
STANDARD_DEVIATION 11.7
Ethnicity (NIH/OMB)
Hispanic or Latino
23 Participants44 Participants67 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
126 Participants137 Participants263 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Legal status
Parole
20 Participants49 Participants69 Participants
Legal status
Probation(including drug court)
129 Participants132 Participants261 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants3 Participants7 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
46 Participants34 Participants80 Participants
Race (NIH/OMB)
More than one race
7 Participants13 Participants20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
91 Participants126 Participants217 Participants
Region of Enrollment
United States
149 Participants181 Participants330 Participants
Sex: Female, Male
Female
44 Participants41 Participants85 Participants
Sex: Female, Male
Male
105 Participants140 Participants245 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1494 / 181
other
Total, other adverse events
0 / 1490 / 181
serious
Total, serious adverse events
12 / 14930 / 181

Outcome results

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).

Time frame: Baseline, 6 months, and 12 months

Population: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)BaselineNot abstinent100 Participants
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)BaselineAbstinent49 Participants
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)6 monthsNot abstinent55 Participants
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)6 monthsAbstinent53 Participants
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)12 monthsNot abstinent62 Participants
Motivational Interviewing Case ManagementChange in Alcohol and Drug Use (Timeline Follow Back)12 monthsAbstinent56 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)12 monthsNot abstinent80 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)BaselineNot abstinent126 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)6 monthsAbstinent63 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)BaselineAbstinent55 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)12 monthsAbstinent71 Participants
Control/Resource ReferralsChange in Alcohol and Drug Use (Timeline Follow Back)6 monthsNot abstinent82 Participants
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.

Time frame: Baseline, 6 months, and 12 months

Population: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Motivational Interviewing Case ManagementChange in Criminal Justice OutcomesBaselineNot incarcerated in past 6 months66 Participants
Motivational Interviewing Case ManagementChange in Criminal Justice OutcomesBaselineIncarcerated in past 6 months83 Participants
Motivational Interviewing Case ManagementChange in Criminal Justice Outcomes6 monthsNot incarcerated in past 6 months94 Participants
Motivational Interviewing Case ManagementChange in Criminal Justice Outcomes6 monthsIncarcerated in past 6 months14 Participants
Motivational Interviewing Case ManagementChange in Criminal Justice Outcomes12 monthsNot incarcerated in past 6 months94 Participants
Motivational Interviewing Case ManagementChange in Criminal Justice Outcomes12 monthsIncarcerated in past 6 months24 Participants
Control/Resource ReferralsChange in Criminal Justice Outcomes12 monthsNot incarcerated in past 6 months105 Participants
Control/Resource ReferralsChange in Criminal Justice OutcomesBaselineNot incarcerated in past 6 months70 Participants
Control/Resource ReferralsChange in Criminal Justice Outcomes6 monthsIncarcerated in past 6 months37 Participants
Control/Resource ReferralsChange in Criminal Justice OutcomesBaselineIncarcerated in past 6 months111 Participants
Control/Resource ReferralsChange in Criminal Justice Outcomes12 monthsIncarcerated in past 6 months45 Participants
Control/Resource ReferralsChange in Criminal Justice Outcomes6 monthsNot incarcerated in past 6 months108 Participants
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.

Time frame: Baseline, 6 months, and 12 months

Population: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.BaselineDidn't have HIV worry25 Participants
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.BaselineHad HIV worry124 Participants
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.6 monthsDidn't have HIV worry41 Participants
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.6 monthsHad HIV worry67 Participants
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.12 monthsDidn't have HIV worry73 Participants
Motivational Interviewing Case ManagementChange in Worries About HIV in Past 6 Months.12 monthsHad HIV worry45 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.12 monthsDidn't have HIV worry98 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.BaselineDidn't have HIV worry48 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.6 monthsHad HIV worry63 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.BaselineHad HIV worry133 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.12 monthsHad HIV worry53 Participants
Control/Resource ReferralsChange in Worries About HIV in Past 6 Months.6 monthsDidn't have HIV worry82 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026