Skip to content

Sustainable HIV Risk Reduction Strategies for Probationers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02777086
Acronym
DRR2
Enrollment
511
Registered
2016-05-19
Start date
2015-09-30
Completion date
2020-03-31
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

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

BEHAVIORALStaySafe

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

Sponsors

Texas Christian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
HIV Knowledge Confidence3-monthsQuestionnaire measure of knowledge, confidence & motivation around HIV knowledge. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence & motivation.
Avoiding Risky Sex3-monthsQuestionnaire 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 & Testing3-monthsQuestionnaire 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 Skills3-monthsQuestionnaire 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

ArmCount
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
Total511

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up9699

Baseline characteristics

CharacteristicStaySafeComparisonTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
261 Participants250 Participants511 Participants
Avoiding risky sex41.1 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 Participants80 Participants160 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
179 Participants170 Participants349 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants
HIV Knowledge Confidence40.2 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 & Testing41.7 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 Participants4 Participants7 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
87 Participants77 Participants164 Participants
Race (NIH/OMB)
More than one race
29 Participants14 Participants43 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
138 Participants153 Participants291 Participants
Region of Enrollment
United States
261 participants250 participants511 participants
Risk Reduction Skills42.7 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 Participants113 Participants249 Participants
Sex: Female, Male
Male
125 Participants137 Participants262 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2610 / 250
other
Total, other adverse events
0 / 2610 / 250
serious
Total, serious adverse events
0 / 2610 / 250

Outcome results

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.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
StaySafeAvoiding Risky Sex43.1 units on a scaleStandard Deviation 5.6
ComparisonAvoiding Risky Sex41.3 units on a scaleStandard Deviation 7.1
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.

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.

ArmMeasureValue (MEAN)Dispersion
StaySafeHIV Knowledge Confidence42.9 units on a scaleStandard Deviation 5.4
ComparisonHIV Knowledge Confidence40.5 units on a scaleStandard Deviation 7.1
Comparison: 3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.p-value: <0.001ANCOVA
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.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
StaySafeHIV Services & Testing44.3 units on a scaleStandard Deviation 5.3
ComparisonHIV Services & Testing42.1 units on a scaleStandard Deviation 5.9
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.

Time frame: 3-months

ArmMeasureValue (MEAN)Dispersion
StaySafeRisk Reduction Skills44.3 units on a scaleStandard Deviation 4.7
ComparisonRisk Reduction Skills43.0 units on a scaleStandard Deviation 5.6

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026