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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Public Health Institute, California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Public Health Institute, California
ClinicalTrials.gov Identifier:
NCT01977092
First received: September 25, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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, reduce recidivism, and increase service utilization for this population.


Condition Intervention
Alcohol and Drug Abuse
Behavioral: Motivational interviewing case management
Behavioral: Resource referrals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing

Resource links provided by NLM:


Further study details as provided by Public Health Institute, California:

Primary Outcome Measures:
  • Change in criminal justice outcomes [ Time Frame: Baseline, 6-mo, 12-mo ] [ Designated as safety issue: No ]
    Measured by number of arrests, convictions, and length of time incarcerated.

  • Change in Alcohol and Drug Use (Alcohol Severity Index & Timeline Follow Back) [ Time Frame: Baseline, 6-mo, 12-mo ] [ Designated as safety issue: No ]
    Measured by number of days of use for specific drugs in last 30 days and last 6 months.

  • Change in needle use and injection, sexual risk behaviors, and HIV status and testing. [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how often needles were used, shared and cleaned; frequency of high risk sexual behaviors; how recently HIV testing was completed and level of concern about exposure to HIV.


Secondary Outcome Measures:
  • Change in Alcohol Severity Index (ASI) Scales [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured utilizing the standard ASI scales.

  • Change in housing stability [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by recent housing situation, how stable the situation is, ability to pay for housing, and how many days living in controlled environments.

  • Change in work and income history [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by level of income and how many days worked in the last 30 days and last 6 months.


Other Outcome Measures:
  • Change in social support [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how frequently the respondent either received or offered support from/to family and friends in the last 12 months.

  • Changes in Alcoholics Anonymous (AA)/ Narcotics Anonymous (NA) involvement [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how many AA/NA meetings were attended in the last 6 months, and measures of identification with AA/NA programs.

  • Changes in services received [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how often common services, such as medical and counseling services, were accessed in the prior 2 months.

  • Changes in support and confrontations with family, friends and professionals about drug and alcohol use [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how often significant people in their lives confronted the respondents about making changes to alcohol and drug use.

  • Changes in occurrence and impact from trauma, post-traumatic stress disorder (PTSD), and abuse history [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by how much past traumatic events are causing bothersome feelings and experiences, whether past physical or sexual abuse has occurred and how recently it has happened.

  • Changes in motivation to change based on the Alcohol and Drug Consequences Questionnaire (ADCQ) [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by two scales that assess motivation to change substance abuse, based on consequences and benefits significant to the respondents.

  • Changes in results from urine screens for drugs [ Time Frame: Baseline, 6-mo and 12-mo ] [ Designated as safety issue: No ]
    Measured by positive or negative drug rest results.


Estimated Enrollment: 330
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 receive 3 individual sessions within the first 2 weeks of entering the SLH. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Behavioral: Motivational interviewing case management
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.
Behavioral: Resource referrals

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 18 years or older
  • Speak English
  • Entered the sober living house in the last 7 days
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977092

Contacts
Contact: Doug Polcin, Ed.D 510-597-3440 dpolcin@arg.org

Locations
United States, California
Alcohol Research Group Not yet recruiting
Emeryville, California, United States, 94608
Principal Investigator: Doug Polcin, Ed.D         
Sponsors and Collaborators
Public Health Institute, California
Investigators
Principal Investigator: Doug Polcin, Ed.D Alcohol Research Group / Public Health Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Public Health Institute, California
ClinicalTrials.gov Identifier: NCT01977092     History of Changes
Other Study ID Numbers: 1R01 DA034973-01A1, R01DA034973-01A1
Study First Received: September 25, 2013
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Public Health Institute, California:
sober living houses
HIV
alcohol and drugs

ClinicalTrials.gov processed this record on October 01, 2014