Trial Outcomes & Findings for The Wise App Trial for Improving Health Outcomes in PLWH (NCT NCT03205982)
NCT ID: NCT03205982
Last Updated: 2024-03-12
Results Overview
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).
COMPLETED
NA
200 participants
Up to 6 months
2024-03-12
Participant Flow
Participant milestones
| Measure |
Control
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
77
|
76
|
|
Overall Study
NOT COMPLETED
|
24
|
23
|
Reasons for withdrawal
| Measure |
Control
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
19
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Withdrawal by PI
|
0
|
1
|
Baseline Characteristics
One participant in control group did not provide baseline data for this measure.
Baseline characteristics by cohort
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.34 years
STANDARD_DEVIATION 10.2 • n=101 Participants
|
49.19 years
STANDARD_DEVIATION 10.9 • n=97 Participants
|
49.26 years
STANDARD_DEVIATION 10.5 • n=198 Participants
|
|
Sex/Gender, Customized
Male
|
67 Participants
n=101 Participants
|
39 Participants
n=97 Participants
|
106 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Female
|
28 Participants
n=101 Participants
|
55 Participants
n=97 Participants
|
83 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Transgender Male
|
2 Participants
n=101 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
4 Participants
n=101 Participants
|
2 Participants
n=97 Participants
|
6 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Other (Unspecified)
|
0 Participants
n=101 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=101 Participants
|
24 Participants
n=97 Participants
|
51 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=101 Participants
|
73 Participants
n=97 Participants
|
147 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=101 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=198 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=101 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=101 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=101 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=101 Participants
|
75 Participants
n=97 Participants
|
146 Participants
n=198 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=101 Participants
|
5 Participants
n=97 Participants
|
13 Participants
n=198 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=101 Participants
|
5 Participants
n=97 Participants
|
7 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=101 Participants
|
12 Participants
n=97 Participants
|
29 Participants
n=198 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=101 Participants
|
97 Participants
n=97 Participants
|
198 Participants
n=198 Participants
|
|
Antiretroviral (ART) Adherence Visual Analog Scale
|
71.76 units on a scale
STANDARD_DEVIATION 26.14 • n=100 Participants • One participant in control group did not provide baseline data for this measure.
|
66.84 units on a scale
STANDARD_DEVIATION 26.63 • n=97 Participants • One participant in control group did not provide baseline data for this measure.
|
69.37 units on a scale
STANDARD_DEVIATION 26.43 • n=197 Participants • One participant in control group did not provide baseline data for this measure.
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants.
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).
Outcome measures
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in ART Adherence - Clever Cap
|
0.385 Times taking medication/day
Standard Deviation 0.487
|
0.445 Times taking medication/day
Standard Deviation 0.497
|
SECONDARY outcome
Timeframe: Baseline, 3 month follow up, and 6 month follow upPopulation: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were corona virus disease (COVID-19) restrictions in place.
The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings. Items are scored such that higher values indicate better adherence, minimum score is 3 and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79).
Outcome measures
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
Baseline
|
9.099 score on a scale
Standard Deviation 3.129
|
8.557 score on a scale
Standard Deviation 2.926
|
|
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
3-Month Follow-up
|
10.667 score on a scale
Standard Deviation 3.458
|
10.099 score on a scale
Standard Deviation 3.345
|
|
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
6-Month Follow-up
|
10.714 score on a scale
Standard Deviation 3.268
|
10.197 score on a scale
Standard Deviation 3.533
|
SECONDARY outcome
Timeframe: Baseline, 3 month follow up, and 6 month follow upPopulation: The number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place.
Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence
Outcome measures
| Measure |
Control
n=84 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=89 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Cluster of Differentiation 4 (CD4) Count
Baseline
|
5.972 cells/mm^3
Standard Deviation 1.102
|
6.060 cells/mm^3
Standard Deviation 0.806
|
|
Change in Cluster of Differentiation 4 (CD4) Count
3-Month Follow-up
|
5.811 cells/mm^3
Standard Deviation 1.389
|
6.102 cells/mm^3
Standard Deviation 0.838
|
|
Change in Cluster of Differentiation 4 (CD4) Count
6-Month Follow-up
|
5.772 cells/mm^3
Standard Deviation 1.341
|
5.974 cells/mm^3
Standard Deviation 0.941
|
SECONDARY outcome
Timeframe: Baseline, 3 month follow up, and 6 month follow upPopulation: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place.
Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.
Outcome measures
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Viral Load
Baseline
|
0.634 copies/ml
Standard Deviation 0.484
|
0.567 copies/ml
Standard Deviation 0.498
|
|
Change in Viral Load
3-Month Follow-up
|
0.536 copies/ml
Standard Deviation 0.502
|
0.444 copies/ml
Standard Deviation 0.5
|
|
Change in Viral Load
6-Month Follow-up
|
0.558 copies/ml
Standard Deviation 0.5
|
0.5 copies/ml
Standard Deviation 0.503
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: The number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place.
This will be measured by the self-reported number of primary care visits.
Outcome measures
| Measure |
Control
n=98 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=95 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Number of Primary Care Visits
Baseline
|
1.153 primary care appointments
Standard Deviation 0.484
|
1.084 primary care appointments
Standard Deviation 0.315
|
|
Change in Number of Primary Care Visits
3-Month Follow-up
|
1.207 primary care appointments
Standard Deviation 0.561
|
1.111 primary care appointments
Standard Deviation 0.316
|
|
Change in Number of Primary Care Visits
6-Month Follow-up
|
1.208 primary care appointments
Standard Deviation 0.592
|
1.24 primary care appointments
Standard Deviation 0.612
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place.
The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider. The minimum total score is 13 and the maximum total score is 52.
Outcome measures
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Score on the Engagement With Health Care Provider Scale
Baseline
|
17.386 score on a scale
Standard Deviation 8.158
|
18.186 score on a scale
Standard Deviation 8.121
|
|
Change in Score on the Engagement With Health Care Provider Scale
3-Month Follow-up
|
16.607 score on a scale
Standard Deviation 6.429
|
18.038 score on a scale
Standard Deviation 8.528
|
|
Change in Score on the Engagement With Health Care Provider Scale
6-Month Follow-up
|
18.221 score on a scale
Standard Deviation 7.918
|
18.039 score on a scale
Standard Deviation 8.589
|
SECONDARY outcome
Timeframe: Baseline, 3 month follow up and 6 month follow upPopulation: Only 198 out of 200 participants were included in the analysis. Valid data was not collected for 2 intervention group participants. In addition, the number of participants analyzed at each timepoint and for each group varied due to study attrition; participants missed visits, were lost to follow-up, and there were COVID-19 restrictions in place.
Technology Acceptance: Perceived Ease of Use and Potential Usefulness 14-item Questionnaire provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception. The minimum total score is 0 and the maximum total score is 70.
Outcome measures
| Measure |
Control
n=101 Participants
WiseApp that delivers fitness reminders
Wise app with fitness reminders: The control group will receive the Wise app with fitness reminders
|
Intervention
n=97 Participants
WiseApp that delivers medication adherence reminders
Wise app with medication adherence reminders: The Intervention group will receive the Wise app that delivers medication adherence reminders.
|
|---|---|---|
|
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
Baseline
|
2.053 score on a scale
Standard Deviation 0.871
|
2.044 score on a scale
Standard Deviation 0.950
|
|
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
3-Month Follow-up
|
1.807 score on a scale
Standard Deviation 0.734
|
1.762 score on a scale
Standard Deviation 0.826
|
|
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
6-Month Follow-up
|
1.861 score on a scale
Standard Deviation 0.959
|
1.692 score on a scale
Standard Deviation 0.733
|
Adverse Events
Control
Intervention
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