Trial Outcomes & Findings for Sustainable HIV Risk Reduction Strategies for Probationers (NCT NCT02777086)
NCT ID: NCT02777086
Last Updated: 2020-10-19
Results Overview
Questionnaire measure of knowledge, confidence \& motivation around HIV knowledge. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence \& motivation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
3-months
Results posted on
2020-10-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
250
|
|
Overall Study
COMPLETED
|
165
|
151
|
|
Overall Study
NOT COMPLETED
|
96
|
99
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
96
|
99
|
Baseline Characteristics
Sustainable HIV Risk Reduction Strategies for Probationers
Baseline characteristics by cohort
| Measure |
StaySafe
n=261 Participants
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.
|
Comparison
n=250 Participants
Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
261 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
511 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
249 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
349 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=99 Participants
|
153 Participants
n=107 Participants
|
291 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
261 participants
n=99 Participants
|
250 participants
n=107 Participants
|
511 participants
n=206 Participants
|
|
HIV Knowledge Confidence
|
40.2 units on a scale
STANDARD_DEVIATION 7.2 • n=99 Participants
|
40.0 units on a scale
STANDARD_DEVIATION 7.4 • n=107 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Avoiding risky sex
|
41.1 units on a scale
STANDARD_DEVIATION 7.3 • n=99 Participants
|
40.6 units on a scale
STANDARD_DEVIATION 7.4 • n=107 Participants
|
40.8 units on a scale
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
HIV Services & Testing
|
41.7 units on a scale
STANDARD_DEVIATION 6.4 • n=99 Participants
|
41.8 units on a scale
STANDARD_DEVIATION 6.5 • n=107 Participants
|
41.8 units on a scale
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Risk Reduction Skills
|
42.7 units on a scale
STANDARD_DEVIATION 5.8 • n=99 Participants
|
42.4 units on a scale
STANDARD_DEVIATION 6.0 • n=107 Participants
|
42.5 units on a scale
STANDARD_DEVIATION 5.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3-monthsPopulation: Outcome analyses were computed on participants in the StaySafe and Comparison groups who had a baseline and a 3-month follow-up survey.
Questionnaire measure of knowledge, confidence \& motivation around HIV knowledge. Values range from 10 to 50 with higher scores indicating higher knowledge, confidence \& motivation.
Outcome measures
| Measure |
StaySafe
n=165 Participants
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.
|
Comparison
n=151 Participants
Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
|
|---|---|---|
|
HIV Knowledge Confidence
|
42.9 units on a scale
Standard Deviation 5.4
|
40.5 units on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: 3-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.
Outcome measures
| Measure |
StaySafe
n=165 Participants
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.
|
Comparison
n=151 Participants
Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
|
|---|---|---|
|
Avoiding Risky Sex
|
43.1 units on a scale
Standard Deviation 5.6
|
41.3 units on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: 3-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.
Outcome measures
| Measure |
StaySafe
n=165 Participants
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.
|
Comparison
n=151 Participants
Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
|
|---|---|---|
|
HIV Services & Testing
|
44.3 units on a scale
Standard Deviation 5.3
|
42.1 units on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 3-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.
Outcome measures
| Measure |
StaySafe
n=165 Participants
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.
|
Comparison
n=151 Participants
Participants are asked to complete baseline, 3-month and 6-month surveys but are not asked to complete StaySafe sessions or other alternate activities.
|
|---|---|---|
|
Risk Reduction Skills
|
44.3 units on a scale
Standard Deviation 4.7
|
43.0 units on a scale
Standard Deviation 5.6
|
Adverse Events
StaySafe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place