Reducing High Risk Behavior in Treatment Court

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Treatment Research Institute

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Treatment Research Institute

ClinicalTrials.gov Identifier:

NCT01481428

First received: November 18, 2011

Last updated: February 2, 2015

Last verified: February 2015

History of Changes

Purpose

This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment 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 Treatment Court

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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:	March 2016
Estimated Primary Completion Date:	February 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.

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 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.

Eligibility


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

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.

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: 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

National Institute on Drug Abuse (NIDA)

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:	February 2, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Treatment Research Institute:


High risk behavior Drug court clients Substance abuse HIV intervention Treatment Court Clients

ClinicalTrials.gov processed this record on February 27, 2015

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