Trial Outcomes & Findings for A Pilot Gaming Adherence Program for Youth Living With HIV (NCT NCT01887210)
NCT ID: NCT01887210
Last Updated: 2018-09-26
Results Overview
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Pilot Gaming Adherence Program for Youth Living With HIV
Baseline characteristics by cohort
| Measure |
IMB Gaming Adherence Intervention
n=32 Participants
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
n=29 Participants
Smart pill bottle cap and mobile phone but no game
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
22.3 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
22.4 years
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Started ARV in past 3 months
Yes
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Started ARV in past 3 months
No
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Gaming Status
Daily or almost daily
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Gaming Status
Not everyday
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Gaming Status
Unknown or not reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sexual Orientation
Heterosexual
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sexual Orientation
Homosexual
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sexual Orientation
Bisexual
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sexual Orientation
Undecided
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Unable to extract viral load data from chart for 9 participants in IMB intervention and 1 in TAU+.
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
Outcome measures
| Measure |
IMB Gaming Adherence Intervention
n=23 Participants
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
n=28 Participants
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Log10 HIV-1 Viral Load
|
1.48 Log10 copies/ml
Standard Deviation 2.07
|
1.82 Log10 copies/ml
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing data for n=1 from TAU+
Past 7 day medication adherence as measured by electronic medication monitoring device.
Outcome measures
| Measure |
IMB Gaming Adherence Intervention
n=32 Participants
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
n=28 Participants
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Electronically Measured Past 7-day Adherence
|
0.29 proportion of adherence
Standard Deviation 0.36
|
0.32 proportion of adherence
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Unable to pull information from chart for 9 participants in the IMB intervention and 6 in the TAU+ groups.
Number of kept medical appointments since baseline.
Outcome measures
| Measure |
IMB Gaming Adherence Intervention
n=23 Participants
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
n=23 Participants
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Number of Kept Medical Appointments
|
1.78 appointments kept since baseline
Standard Deviation 1.24
|
1.74 appointments kept since baseline
Standard Deviation 1.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: Missing data for n=2 from IMB intervention, n=2 from TAU+
Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale. This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment. Five items were summed to get a total Behavioral Skills subscale score. Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment.
Outcome measures
| Measure |
IMB Gaming Adherence Intervention
n=30 Participants
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
|
Enhanced Treatment as Usual
n=27 Participants
Smart pill bottle cap and mobile phone but no game
|
|---|---|---|
|
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
|
19.83 units on a scale
Standard Deviation 4.68
|
19.48 units on a scale
Standard Deviation 5.12
|
Adverse Events
IMB Gaming Adherence Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual
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