NCT02777086: DRR2

Sustainable HIV Risk Reduction Strategies for Probationers

Completed NA Results posted Last updated 19 October 2020

What this trial tests

NA trial testing StaySafe in Health Behavior in 511 participants. Completed in 31 March 2020.

Timeline

30 September 2015

Primary endpoint
6 August 2019

31 March 2020

Quick facts

Lead sponsor	Texas Christian University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	511
Start date	30 September 2015
Primary completion	6 August 2019
Estimated completion	31 March 2020
Sites	3 locations across United States

Drugs / interventions tested

• StaySafe

Conditions studied

• Health Behavior — all drugs for Health Behavior →

Sponsor

Texas Christian University

Who can join

18 and older, any sex, with Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HIV Knowledge Confidence Primary · 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.

Group	Value	95% CI
StaySafe	42.9	± 5.4
Comparison	40.5	± 7.1

Avoiding Risky Sex Primary · 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.

Group	Value	95% CI
StaySafe	43.1	± 5.6
Comparison	41.3	± 7.1

HIV Services & Testing Primary · 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.

Group	Value	95% CI
StaySafe	44.3	± 5.3
Comparison	42.1	± 5.9

Risk Reduction Skills Primary · 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.

Group	Value	95% CI
StaySafe	44.3	± 4.7
Comparison	43.0	± 5.6

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An evaluation of StaySafe, a tablet app to improve health risk decision-making among people under community supervision.
   Lehman WEK, Pankow J, Muiruri R, Joe GW, et al · · 2021 · cited 3× · PMID 34118712 · DOI 10.1016/j.jsat.2021.108480
2. The Effectiveness of the <i>StaySafe</i> Intervention Using a Paradigm for Predicting Missing Outcome Data.
   Joe GW, Lehman WEK, Yang Y, Knight K. · · 2025 · PMID 37956984 · DOI 10.1177/01632787231212462
3. Decision-Making Styles as a Moderator on the Efficacy of the <i>StaySafe</i> Tablet Intervention.
   Joe GW, Lehman WEK, Pankow J, Wiese A, et al · · 2023 · PMID 37184071 · DOI 10.1080/10826084.2023.2212301