- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481428
Reducing High Risk Behavior in Treatment Court
March 27, 2023 updated by: Treatment Research Institute
Delivering HIV Risk Reduction Services in Treatment Court
This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment courts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Four hundred consenting treatment 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 treatment 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.
Study Type
Interventional
Enrollment (Actual)
371
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Philadelphia Treatment Court
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be at least 18 years of age;
- be charged with a non-violent felony offense
- have no more than two prior non-violent convictions or diversionary opportunities
- be willing to participate in the treatment court program for at least 12 months
- be in need of treatment for substance 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement in high risk behaviors
Time Frame: 15 month follow-up
|
Measured by the Risk Assessment Battery (RAB)
|
15 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of HIV testing
Time Frame: 15 month follow-up
|
15 month follow-up
|
Condom Procurement
Time Frame: 15 month follow-up
|
15 month follow-up
|
Self-reported Condom Use
Time Frame: 15 month follow-up
|
15 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David S Festinger, Ph.D., Treatment Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
November 18, 2011
First Submitted That Met QC Criteria
November 28, 2011
First Posted (Estimate)
November 29, 2011
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #1002
- R01DA030257 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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