Sustainable HIV Risk Reduction Strategies for Probationers
DRR2
1 other identifier
interventional
511
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
3 active sites
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
Study Start
First participant enrolled
September 30, 2015
CompletedFirst Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
October 1, 2020
3.9 years
April 20, 2016
September 23, 2020
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
StaySafe
EXPERIMENTALParticipants 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 INTERVENTIONParticipants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
Interventions
StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.
Eligibility Criteria
You may qualify if:
- On probation
- Has received prior drug treatment from an in-prison, residential, or intensive outpatient program
- Can read at the 4th grade level
You may not qualify if:
- Does not have 6 months of probation left
- Is not a sex offender
- Does not have a serious mental health diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dallas County CSCD
Dallas, Texas, 76129, United States
Tarrant County CSCD
Fort Worth, Texas, 76119, United States
Harris County CSCD
Houston, Texas, 77093, United States
Related Publications (2)
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.
PMID: 37956984DERIVEDJoe 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.
PMID: 37184071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Wayne E.K. Lehman, Ph.D.
- Organization
- Texas Christian University
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne E Lehman, PhD
Institute of Behavioral Research, Texas Christian University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
May 19, 2016
Study Start
September 30, 2015
Primary Completion
August 6, 2019
Study Completion
March 31, 2020
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- two years after conclusion of the study
- Access Criteria
- no restrictions
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.