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Reducing High Risk Behavior in Treatment Court

Primary Purpose

Substance Abuse, HIV

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-facilitated HIV intervention
Attention Control
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring High risk behavior, Drug court clients, Substance abuse, HIV intervention, Treatment Court Clients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 treatment court program for at least 12 months
  5. 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.

Sites / Locations

  • Philadelphia Treatment Court

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Attention Control

Computer-facilitated HIV intervention

Arm Description

Outcomes

Primary Outcome Measures

Engagement in high risk behaviors
Measured by the Risk Assessment Battery (RAB)

Secondary Outcome Measures

Rate of HIV testing
Condom Procurement
Self-reported Condom Use

Full Information

First Posted
November 18, 2011
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01481428
Brief Title
Reducing High Risk Behavior in Treatment Court
Official Title
Delivering HIV Risk Reduction Services in Treatment Court
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, HIV
Keywords
High risk behavior, Drug court clients, Substance abuse, HIV intervention, Treatment Court Clients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
Active Comparator
Arm Title
Computer-facilitated HIV intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Computer-facilitated HIV intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Engagement in high risk behaviors
Description
Measured by the Risk Assessment Battery (RAB)
Time Frame
15 month follow-up
Secondary Outcome Measure Information:
Title
Rate of HIV testing
Time Frame
15 month follow-up
Title
Condom Procurement
Time Frame
15 month follow-up
Title
Self-reported Condom Use
Time Frame
15 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Festinger, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Treatment Court
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Reducing High Risk Behavior in Treatment Court

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