Trial Outcomes & Findings for Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot) (NCT NCT05938413)
NCT ID: NCT05938413
Last Updated: 2025-03-07
Results Overview
Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (\>= 200 copies/mL in EHR; \>= 500 copies/mL in DBS) and not detectable viral load (\<200 copies/mL in EHR, \<500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Control
Standard of care
|
Intervention or CHAMPS
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).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Control
Standard of care
|
Intervention or CHAMPS
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
Baseline characteristics by cohort
| Measure |
Control
n=20 Participants
Standard of care
|
Intervention or CHAMPS
n=20 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).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 13.52 • n=99 Participants
|
46.5 years
STANDARD_DEVIATION 11.89 • n=107 Participants
|
47.85 years
STANDARD_DEVIATION 12.64 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Something Else
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 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
|
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
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Relationship Status
Single
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Relationship Status
In a relationship with a man
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Relationship Status
In a relationship with a woman
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Relationship Status
Divorced/separated from a man
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Relationship Status
Divorced/separated from a woman
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Relationship Status
Widowed
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Relationship Status
Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Children
No
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Children
Yes
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Highest Level of Education
None
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Highest Level of Education
Elementary School
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Highest Level of Education
Some high school, no diploma
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Highest Level of Education
High school diploma or equivalent
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Highest Level of Education
Some college
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Highest Level of Education
Associate degree or technical degree
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Highest Level of Education
Bachelor/college degree
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Highest Level of Education
Professional or graduate degree
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Viral Load
Viral Load Not Detectable
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Viral Load
Viral Load Detectable
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Score on the Self-Rating Scale Item
|
4.80 units on a scale
STANDARD_DEVIATION 1.34 • n=99 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.35 • n=107 Participants
|
4.85 units on a scale
STANDARD_DEVIATION 1.33 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 17 analyzed as an insufficient sample was provided by n=1 (did not yield a result)
Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (\>= 200 copies/mL in EHR; \>= 500 copies/mL in DBS) and not detectable viral load (\<200 copies/mL in EHR, \<500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline.
Outcome measures
| Measure |
Control
n=17 Participants
Standard of care
|
Intervention or CHAMPS
n=12 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).
|
|---|---|---|
|
Viral Load
Viral Load Not Detectable
|
15 Participants
|
11 Participants
|
|
Viral Load
Viral Load Detectable
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This outcome measures ART adherence using CleverCap. The control group is not reported in this outcome as they were not exposed to the intervention and therefore did not receive the CleverCap device.
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 3 months), and it is a count response (number of times taking medication each day). The percentage of their prescribed doses taken will be reported.
Outcome measures
| Measure |
Control
n=12 Participants
Standard of care
|
Intervention or CHAMPS
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).
|
|---|---|---|
|
Antiretroviral Therapy (ART) Adherence - CleverCap
|
60.08 percentage of prescribed doses
Standard Deviation 19.15
|
—
|
SECONDARY outcome
Timeframe: 3 monthsThe Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent).
Outcome measures
| Measure |
Control
n=18 Participants
Standard of care
|
Intervention or CHAMPS
n=12 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).
|
|---|---|---|
|
Score on the Self-Rating Scale Item (SRSI)
|
5.27 score on a scale
Standard Deviation 1.23
|
5.25 score on a scale
Standard Deviation 1.17
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention or CHAMPS
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