Sustainable HIV Risk Reduction Strategies for Probationers (DRR2)

Sustainable HIV Risk Reduction Strategies for Criminal Justice (CJ) Systems

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: StaySafe

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.

• Study Type: Interventional
• Enrollment (Actual): 511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 76129
      • Dallas County CSCD
    • Fort Worth, Texas, United States, 76119
      • Tarrant County CSCD
    • Houston, Texas, United States, 77093
      • Harris County CSCD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StaySafe; Participants are asked to complete 12 brief, self-administered tablet computer sessions designed to improve decision-making around health risk behaviors. Sessions typically take about 10 minutes each to complete and are scheduled prior to or after probationer group or individual appointments at their probation facility. Sessions are scheduled about once per week.	Behavioral: StaySafe; StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.
No Intervention: Comparison; Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Knowledge Confidence	Questionnaire measure of knowledge, confidence & motivation around HIV knowledge. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.	3-months
Avoiding Risky Sex	Questionnaire measure of knowledge, confidence, and motivation in avoiding risky sex behaviors. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.	3-months
HIV Services & Testing	Questionnaire measure of knowledge, and motivation around getting tested for HIV and obtaining HIV services. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.	3-months
Risk Reduction Skills	Questionnaire measure of knowledge, confidence and motivation around risk reduction skills. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.	3-months

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Wayne E Lehman, PhD, Institute of Behavioral Research, Texas Christian University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2015
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Decision-making; Risk Behaviors
• Other Study ID Numbers: DA25885-1506-060-1508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data files will be prepared at the conclusion of the study to be embargoed for two years after the end of grant funding for archiving in the National Addiction and HIV Data Archives (NAHDAP) funded by the National Institute on Drug Abuse (NIDA) and hosted by the Inter-university Consortium for Political and Social Research, which is part of the University of Michigan's Institute for Social Research. NAHDAP archives and preserves data produced by research grants to support secondary data analysis by other researchers.
• IPD Sharing Time Frame: two years after conclusion of the study
• IPD Sharing Access Criteria: no restrictions
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF