Reducing High Risk Behavior in Drug Court

This study is currently recruiting participants.
Verified December 2012 by Treatment Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01481428
First received: November 18, 2011
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in drug courts.


Condition Intervention Phase
Substance Abuse
HIV
Behavioral: Computer-facilitated HIV intervention
Behavioral: Attention Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Delivering HIV Risk Reduction Services in Drug Court

Resource links provided by NLM:


Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • engagement in high risk behaviors [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    Measured by the Risk Assessment Battery (RAB)


Secondary Outcome Measures:
  • rate of HIV testing [ Time Frame: 15 month follow-up ] [ Designated as safety issue: Yes ]
  • Condom Procurement [ Time Frame: 15 month follow-up ] [ Designated as safety issue: Yes ]
  • Self-reported Condom Use [ Time Frame: 15 month follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Attention Control Behavioral: Attention Control
Life skills training DVDs that match the duration of the anticipated experimental condition. The DVDs address topics such as positive listening skills, anger management, and stress reduction.
Experimental: Computer-facilitated HIV intervention Behavioral: Computer-facilitated HIV intervention
Individuals assigned to the experimental condition will complete the self-directed CARE HIV intervention during each of their first three sessions. The 20 minute intervention sessions involve several components including a brief risk assessment, review of identified risks, structured skill building videos, and the development of a risk prevention action plan. Because of the adaptive nature of the CARE program, the content of each session will be tailored to address the current risks of the participant. While the main focus of the intervention is on risk, individuals who report being HIV infected will receive a referral to treatment if they are not currently receiving medical care and their session will address, among other things, adherence to HIV care.

Detailed Description:

Four hundred consenting felony drug court participants will be randomly assigned to either an HIV intervention group (n = 200) or an attention control group. All clients will attend their regularly scheduled status hearings which are scheduled approximately every six weeks. Clients in the HIV intervention group will receive a brief computerized, self-administered HIV risk reduction intervention following each of their first three status hearings. Clients in the attention control condition will view a series of educational life-skill videos of matched length following each of their first three status hearings. The primary outcome will be engagement in high risk behaviors as measured by the Risk Assessment Battery (RAB). Secondary HIV-related outcomes will include: (1) rate of HIV testing, (2) condom procurement, and (3) self-reported condom use. Tertiary outcomes related to drug court compliance will include: (1) drug court graduation, (2) urinalysis-confirmed drug abstinence, (3) case management attendance, and (4) satisfaction with case management. In addition, we will conduct preliminary cost and cost-effectiveness analyses on the delivery of the brief computerized HIV intervention. Assessments will be conducted at baseline and 9- and 15-months post admission.

  Eligibility

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

Inclusion Criteria:

  1. be at least 18 years of age;
  2. be charged with a non-violent felony offense
  3. have no more than two prior non-violent convictions or diversionary opportunities
  4. be willing to participate in the drug court program for at least 12 months
  5. be in need of treatment for drug abuse or dependence as assessed by case management.

Exclusion Criteria:

  • Elderly subjects and those with medical problems will be included in the research as long as they do not have any physical or psychiatric condition that would impede their ability to give competent consent to research participation or to understand the research instruments.
  • Those individuals who are intoxicated, cognitively impaired, or psychiatrically unstable when approached will not be included; however, such individuals may subsequently be included if the disqualifying condition subsides.
  • Spanish speaking only individuals.
  • Client remanded to jail or residential treatment facilities at the time of Treatment Court enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481428

Contacts
Contact: David S Festinger, Ph.D. 215-399-0980 ext 126 dfestinger@tresearch.org
Contact: Karen Dugosh, Ph.D. 215-399-0980 ext 104 kdugosh@tresearch.org

Locations
United States, Pennsylvania
Philadelphia Treatment Court Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: David S Festinger, Ph.D.     215-399-0980 ext 126     dfestinger@tresearch.org    
Contact: Caitlin Ryan, BA     2153990980 ext 121     cryan@tresearch.com    
Principal Investigator: David S Festinger, Ph.D.            
Sub-Investigator: Karen Dugosh, Ph.D.            
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: David S Festinger, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01481428     History of Changes
Other Study ID Numbers: #1002, R01DA030257
Study First Received: November 18, 2011
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
High risk behavior
Drug court clients
Substance abuse
HIV intervention

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 14, 2013