Clinical trial NCT02777086: Sustainable HIV Risk Reduction Strategies for Probationers
Official title: Sustainable HIV Risk Reduction Strategies for Criminal Justice (CJ) Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: HIV
Risk Behaviors
Decision-making
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is to develop and test a self-administered tablet computer app, StaySafe, for probationers under community supervision that is designed to improve decision-making skills around health risk behaviors, especially involving HIV and hepatitis B \& C risks. StaySafe utilizes materials and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to increase positive decision-making skills for offenders in the last phase of their prison-based substance abuse treatment before transitioning back to the community.

Detailed description: The purpose of the TCU DRR2 project is to adapt ideas and concepts from an in-prison, group-based curriculum designed to improved decision-making skills around health risk behaviors for incarcerated offenders in the last phase of substance abuse treatment for a self-administered computer app that targets probationers under community supervision. Programming for HIV in probation settings is limited and this project aims to address needs with an easy to use computer app that is designed to improve decision-making about health risks among probationers in the community. The computer app utilizes an evidence-based schema called WORKIT and is based on a dual processing model of judgment and decision-making that includes vicarious and virtual learning approaches and repetition in order to learn and practice the schema and move it from slower analytical processing to faster experiential processing.

StaySafe includes 12 brief sessions, each of which takes about 10 minutes to complete. Nine of the sessions utilize the WORKIT model and three session use a participant choice activity in which probationers can choose from among several informational activities designed to reinforce lessons learned and provide some variation to completing WORKIT sessions. The first session includes an introduction to using the app on the tablet and guides the participant through a WORKIT session. In each subsequent WORKIT session, the participant chooses a relevant problem to work on during that session from a list of problems. A brief video is then shown in which two people are having a conversation around the problem and make a decision. The participant rates the decision before working through the WORKIT process around the chosen problem. This involves determining what the problem is, who is affected by the problem and who can help with the problem, then identifying options to address the problem, rating the options, knowing what option to choose, imagining the steps to carry out the option, and then testing the results. Sessions are typically scheduled about every two weeks.

Participants are recruited by research staff for the study from probation offices where substance abuse groups are conducted. All assessment and StaySafe sessions are administered by research staff at the probation facility when probationers otherwise report for meetings or groups. Compensation for time involved in the study is provided in terms of payments toward probation fees. After an Institutional Review Board (IRB)-approved consent procedure, participants are scheduled for a baseline survey that takes about 30 minutes to complete. After the baseline survey is completed, participants are randomly assigned to either the StaySafe condition or a comparison condition. Participants in the StaySafe condition are then scheduled for their first StaySafe session typically within a week and are asked to complete twelve sessions within the next 6 months, followed by 6-month and 12-month follow-up surveys. Participants randomly assigned to a comparison condition are informed that they will be contacted in about 6 months to schedule a 6-month survey and again for a 12-month survey.

Eligibility criteria: Inclusion Criteria:

* On probation
* Has received prior drug treatment from an in-prison, residential, or intensive outpatient program
* Can read at the 4th grade level

Exclusion Criteria:

* Does not have 6 months of probation left
* Is not a sex offender
* Does not have a serious mental health diagnosis

Primary outcomes:
measure: HIV Knowledge Confidence
timeFrame: 3-months
measure: Avoiding Risky Sex
timeFrame: 3-months
measure: HIV Services & Testing
timeFrame: 3-months
measure: Risk Reduction Skills
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas County CSCD
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County CSCD
state: Texas
city: Houston
country: United States
facility: Harris County CSCD
state: Texas
Study officials:
affiliation: Institute of Behavioral Research, Texas Christian University
name: Wayne E Lehman, PhD
role: PRINCIPAL_INVESTIGATOR
References: