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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01481428
Other study ID # #1002
Secondary ID R01DA030257
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2012
Est. completion date December 2016

Study information

Verified date March 2023
Source Public Health Management Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 371
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States Philadelphia Treatment Court Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Treatment Research Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Engagement in high risk behaviors Measured by the Risk Assessment Battery (RAB) 15 month follow-up
Secondary Rate of HIV testing 15 month follow-up
Secondary Condom Procurement 15 month follow-up
Secondary Self-reported Condom Use 15 month follow-up
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