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Completed

NCT Number: NCT02777086

Sustainable HIV Risk Reduction Strategies for Probationers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dallas County CSCD, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StaySafe

Behavioral

StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.

Primary outcomes

  1. HIV Knowledge Confidence

    Time frame: 3-months

    Questionnaire measure of knowledge, confidence & motivation around HIV knowledge. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.

  2. Avoiding Risky Sex

    Time frame: 3-months

    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. HIV Services & Testing

    Time frame: 3-months

    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.

  4. Risk Reduction Skills

    Time frame: 3-months

    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.

Sponsors and collaborators

Lead sponsor

Texas Christian University

Other

Registry information

Official study title

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

Acronym: DRR2

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 19, 2016
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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