Health Behavior
Conditions
Keywords
HIV, Risk Behaviors, Decision-making
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.
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.
Interventions
StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Knowledge Confidence | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 261 |
| 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. | 250 |
| Total | 511 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 96 | 99 |
Baseline characteristics
| Characteristic | StaySafe | Comparison | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 261 Participants | 250 Participants | 511 Participants |
| Avoiding risky sex | 41.1 units on a scale STANDARD_DEVIATION 7.3 | 40.6 units on a scale STANDARD_DEVIATION 7.4 | 40.8 units on a scale STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants | 80 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 170 Participants | 349 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| HIV Knowledge Confidence | 40.2 units on a scale STANDARD_DEVIATION 7.2 | 40.0 units on a scale STANDARD_DEVIATION 7.4 | 40.1 units on a scale STANDARD_DEVIATION 7.3 |
| HIV Services & Testing | 41.7 units on a scale STANDARD_DEVIATION 6.4 | 41.8 units on a scale STANDARD_DEVIATION 6.5 | 41.8 units on a scale STANDARD_DEVIATION 6.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 87 Participants | 77 Participants | 164 Participants |
| Race (NIH/OMB) More than one race | 29 Participants | 14 Participants | 43 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 138 Participants | 153 Participants | 291 Participants |
| Region of Enrollment United States | 261 participants | 250 participants | 511 participants |
| Risk Reduction Skills | 42.7 units on a scale STANDARD_DEVIATION 5.8 | 42.4 units on a scale STANDARD_DEVIATION 6 | 42.5 units on a scale STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 136 Participants | 113 Participants | 249 Participants |
| Sex: Female, Male Male | 125 Participants | 137 Participants | 262 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 261 | 0 / 250 |
| other Total, other adverse events | 0 / 261 | 0 / 250 |
| serious Total, serious adverse events | 0 / 261 | 0 / 250 |
Outcome results
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.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StaySafe | Avoiding Risky Sex | 43.1 units on a scale | Standard Deviation 5.6 |
| Comparison | Avoiding Risky Sex | 41.3 units on a scale | Standard Deviation 7.1 |
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.
Time frame: 3-months
Population: Outcome analyses were computed on participants in the StaySafe and Comparison groups who had a baseline and a 3-month follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StaySafe | HIV Knowledge Confidence | 42.9 units on a scale | Standard Deviation 5.4 |
| Comparison | HIV Knowledge Confidence | 40.5 units on a scale | Standard Deviation 7.1 |
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.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StaySafe | HIV Services & Testing | 44.3 units on a scale | Standard Deviation 5.3 |
| Comparison | HIV Services & Testing | 42.1 units on a scale | Standard Deviation 5.9 |
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.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| StaySafe | Risk Reduction Skills | 44.3 units on a scale | Standard Deviation 4.7 |
| Comparison | Risk Reduction Skills | 43.0 units on a scale | Standard Deviation 5.6 |