Trial Outcomes & Findings for Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (NCT NCT01957865)
NCT ID: NCT01957865
Last Updated: 2017-05-03
Results Overview
ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
real time (for 9 months)
Results posted on
2017-05-03
Participant Flow
Participant milestones
| Measure |
Fixed SMS, Real-time Monitoring
SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Triggered SMS, Real-time Monitoring
SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Control
Real-time adherence monitoring only (no SMS)
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
|
Overall Study
COMPLETED
|
21
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Fixed SMS, Real-time Monitoring
SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Triggered SMS, Real-time Monitoring
SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Control
Real-time adherence monitoring only (no SMS)
|
|---|---|---|---|
|
Overall Study
Found HIV negative
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
Baseline Characteristics
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Baseline characteristics by cohort
| Measure |
Fixed SMS, Real-time Monitoring
n=21 Participants
SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Triggered SMS, Real-time Monitoring
n=20 Participants
SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
|
Control
n=22 Participants
Real-time adherence monitoring only (no SMS)
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
33 years
n=7 Participants
|
27 years
n=5 Participants
|
30 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
Uganda
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
22 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Median CD4 count
|
309 cells/mm^3
n=5 Participants
|
291 cells/mm^3
n=7 Participants
|
382 cells/mm^3
n=5 Participants
|
309 cells/mm^3
n=4 Participants
|
PRIMARY outcome
Timeframe: real time (for 9 months)Population: The participant found to be HIV negative was not included in the analysis.
ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.
Outcome measures
| Measure |
Fixed SMS, Real-time Monitoring
n=21 Participants
Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence.
|
Triggered SMS, Real-time Monitoring
n=20 Participants
Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence.
|
Control
n=21 Participants
Real-time adherence monitoring only (no SMS)
|
|---|---|---|---|
|
Antiretroviral Therapy (ART) Adherence Levels
|
91 Percent adherence
Standard Deviation 9
|
79 Percent adherence
Standard Deviation 18
|
79 Percent adherence
Standard Deviation 22
|
SECONDARY outcome
Timeframe: After month 9Population: Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis.
HIV RNA suppression (\<100 copies/ml) in each study arm
Outcome measures
| Measure |
Fixed SMS, Real-time Monitoring
n=21 Participants
Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence.
|
Triggered SMS, Real-time Monitoring
n=20 Participants
Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence.
|
Control
n=21 Participants
Real-time adherence monitoring only (no SMS)
|
|---|---|---|---|
|
HIV RNA Suppression
|
20 number of participants
|
15 number of participants
|
19 number of participants
|
Adverse Events
Fixed SMS, Real-time Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triggered SMS, Real-time Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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