Health BehaviorDRR2NCT02777086
Sustainable HIV Risk Reduction Strategies for Probationers
A study testing StaySafe in people with Health Behavior, run by Texas Christian University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- StaySafe
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2015to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On probation
- Has received prior drug treatment from an in-prison, residential, or intensive outpatient program
- Can read at the 4th grade level
Who cannot join
- Does not have 6 months of probation left
- Is not a sex offender
- Does not have a serious mental health diagnosis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dallas County CSCD
Dallas, Texas, 76129
Tarrant County CSCD
Fort Worth, Texas, 76119
Harris County CSCD
Houston, Texas, 77093
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- StaySafe
- Keywords
- HIV, Risk Behaviors, Decision-making
- Medical subject headings
- Health Behavior, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaySafeBehavioural
StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: StaySafe |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start30 Sep 2015
- Primary completion6 Aug 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne E Lehman, PhD, Principal investigator, Institute of Behavioral Research, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777086
- Sponsor's protocol ID
- DA25885-1506-060-1508
- Acronym
- DRR2
- Status last verified
- Oct 2020
- First submitted
- 20 Apr 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37956984Joe 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.
PubMed 37184071
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable HIV Risk Reduction Strategies for Criminal Justice (CJ) Systems
- ClinicalTrials.gov ID
- NCT02777086
- Acronym / sponsor ID
- DRR2 / DA25885-1506-060-1508
- Conditions
- Health Behavior
- Keywords
- HIV, Risk Behaviors, Decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StaySafe | Experimental | Behavioral: StaySafeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On probation
- Has received prior drug treatment from an in-prison, residential, or intensive outpatient program
- Can read at the 4th grade level
Key exclusion criteria (3 listed)
- Does not have 6 months of probation left
- Is not a sex offender
- Does not have a serious mental health diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StaySafeStaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors. | Behavioural | StaySafe |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37956984Joe 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.
- Derived from this study: PubMed 37184071Joe 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne E Lehman, PhD principal investigator
Institute of Behavioral Research, Texas Christian University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StaySafe in people with Health Behavior, run by Texas Christian University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Knowledge Confidence (time frame: 3-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777086, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.