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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StaySafe | Experimental | 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. |
|
| Comparison | No Intervention | Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StaySafe | Behavioral | StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne E Lehman, PhD | Institute of Behavioral Research, Texas Christian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas County CSCD | Dallas | Texas | 76129 | United States | ||
| Tarrant County CSCD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37956984 | Derived | Joe GW, Lehman WEK, Yang Y, Knight K. The Effectiveness of the StaySafe Intervention Using a Paradigm for Predicting Missing Outcome Data. Eval Health Prof. 2025 Sep;48(3):374-383. doi: 10.1177/01632787231212462. Epub 2023 Nov 13. | |
| 37184071 | Derived | Joe GW, Lehman WEK, Pankow J, Wiese A, Knight K. Decision-Making Styles as a Moderator on the Efficacy of the StaySafe Tablet Intervention. Subst Use Misuse. 2023;58(9):1132-1142. doi: 10.1080/10826084.2023.2212301. Epub 2023 May 15. |
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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.
two years after conclusion of the study
no restrictions
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Recruiting for the study began in September, 2015 and extended through February, 2019. Recruitment occurred in probation offices in two large counties in Texas and two residential substance abuse treatment centers for people on probation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Outcome analyses were computed on participants in the StaySafe and Comparison groups who had a baseline and a 3-month follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
|
6 months
No adverse events were observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. StaySafe: StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors. |
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Samples were recruited from community probation and residential probation substance abuse treatment centers. Attrition in both samples due to absconding (higher in community sample) and loss of contact with the participants in community sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wayne E.K. Lehman, Ph.D. | Texas Christian University | 18172577226 | w.lehman@tcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Fort Worth |
| Texas |
| 76119 |
| United States |
| Harris County CSCD | Houston | Texas | 77093 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
|
|
|
| 0 |
| 261 |
| 0 |
| 261 |
| 0 |
| 261 |
| EG001 | 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. | 0 | 250 | 0 | 250 | 0 | 250 |
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