NCT01481428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

November 18, 2011

Last Update Submit

March 27, 2023

Conditions

Substance AbuseHIV

Keywords

High risk behaviorDrug court clientsSubstance abuseHIV interventionTreatment Court Clients

Outcome Measures

Primary Outcomes (1)

  • Engagement in high risk behaviors

    Measured by the Risk Assessment Battery (RAB)

    15 month follow-up

Secondary Outcomes (3)

  • Rate of HIV testing

    15 month follow-up

  • Condom Procurement

    15 month follow-up

  • Self-reported Condom Use

    15 month follow-up

Study Arms (2)

Attention Control

ACTIVE COMPARATOR
Behavioral: Attention Control

Computer-facilitated HIV intervention

EXPERIMENTAL
Behavioral: Computer-facilitated HIV intervention

Interventions

Computer-facilitated HIV interventionBEHAVIORAL

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.

Computer-facilitated HIV intervention
Attention ControlBEHAVIORAL

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.

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia Treatment Court

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • David S Festinger, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 29, 2011

Study Start

September 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

US(1)