Trial Outcomes & Findings for Community Health Worker And MHealth to ImProve Viral Suppression (NCT NCT04562649)
NCT ID: NCT04562649
Last Updated: 2025-02-17
Results Overview
The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
6 month follow up, 12 month follow up
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Intervention
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
113
|
122
|
|
Overall Study
NOT COMPLETED
|
37
|
28
|
Reasons for withdrawal
| Measure |
Intervention
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
Standard of care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
|
Overall Study
Lost to Follow-up
|
26
|
20
|
Baseline Characteristics
Community Health Worker And MHealth to ImProve Viral Suppression
Baseline characteristics by cohort
| Measure |
Intervention
n=150 Participants
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
n=150 Participants
Standard of care
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
104 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
150 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Education Level
Less than high school
|
45 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Education Level
High school education/(General Education Development (GED)
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Education Level
Greater than high school
|
58 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Education Level
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Homosexual
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sexual Orientation
Heterosexual
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sexual Orientation
Other
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sexual Orientation
Unknown
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Viral Suppression
Yes
|
104 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Viral Suppression
No
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Viral Suppression
Unknown
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 month follow up, 12 month follow upPopulation: N=123 intervention (CHAMPS) participants completed the 6 month visit. Of the 123 samples collected, four samples could not be processed by the laboratory, resulting in 119 analyzed. N=113 intervention participants completed the 12 month visit. Of the 113 completers, seven samples could not be processed by the laboratory, resulting in 106 analyzed in the intervention arm. N=116 analyzed in the control arm at month 12, as six samples could not be processed by the laboratory.
The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.
Outcome measures
| Measure |
Intervention
n=119 Participants
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
n=122 Participants
Standard of care
|
|---|---|---|
|
Number of Virally Suppressed Participants
6 months
|
97 Participants
|
94 Participants
|
|
Number of Virally Suppressed Participants
12 months
|
79 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 141 participants analyzed as 141 participants used the CleverCap device and app. Nine participants never used the CleverCap device and app.
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 12 months) and report the number of days used.
Outcome measures
| Measure |
Intervention
n=141 Participants
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
Standard of care
|
|---|---|---|
|
Antiretroviral Therapy (ART) Adherence - CleverCap
|
244 Days
Standard Deviation 124
|
—
|
SECONDARY outcome
Timeframe: 6 month follow up and 12 month follow upThe Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent).
Outcome measures
| Measure |
Intervention
n=113 Participants
Wise App that delivers medication adherence reminders and community health worker sessions
Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW).
|
Control
n=122 Participants
Standard of care
|
|---|---|---|
|
Change in Score on the Self-Rating Scale Item (SRSI)
|
0.04 score on a scale
Standard Error 0.13
|
-0.08 score on a scale
Standard Error 0.13
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 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