Trial Outcomes & Findings for Mopati: A Pilot Hiv Treatment Partner Intervention In Botswana (NCT NCT04796610)
NCT ID: NCT04796610
Last Updated: 2023-11-01
Results Overview
Viral suppression will be defined as viral load \< 400 cp/ml
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
6 months
Results posted on
2023-11-01
Participant Flow
Note that both patients and treatment partners were recruited and participated in the intervention. However, results are only reported for patients (and not treatment partners) as the primary and secondary trial outcomes apply to patients only.
COVID-19 was a large challenge to recruitment and study implementation as a whole
Participant milestones
| Measure |
Intervention Patients
Unsuppressed patients with HIV at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Patients
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
Intervention Treatment Partners
Unsuppressed patients with HIV at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Treatment Partners
Treatment partners of patients at the control clinic who will receive standard of care at the clinic during the intervention assessment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
17
|
28
|
|
Overall Study
COMPLETED
|
27
|
30
|
16
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Intervention Patients
Unsuppressed patients with HIV at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Patients
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
Intervention Treatment Partners
Unsuppressed patients with HIV at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Treatment Partners
Treatment partners of patients at the control clinic who will receive standard of care at the clinic during the intervention assessment period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
1
|
Baseline Characteristics
2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
Baseline characteristics by cohort
| Measure |
Intervention Patients
n=30 Participants
Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
The Mopati intervention provides (1) training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners and (2) education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.
Note that both patients and treatment partners were recruited and participated in the intervention. However, counts, baseline characteristics, and results are only reported for patients (and not treatment partners) as the primary and secondary trial outcomes apply to patients only.
|
Control Patients
n=30 Participants
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
Intervention Treatment Partners
n=17 Participants
Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Treatment Partners
n=28 Participants
Treatment partners will not receive any intervention; treatment partners' patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 10.4 • n=30 Participants
|
43.8 years
STANDARD_DEVIATION 11.6 • n=30 Participants
|
40.8 years
STANDARD_DEVIATION 11.2 • n=17 Participants
|
40.1 years
STANDARD_DEVIATION 9.5 • n=28 Participants
|
40.5 years
STANDARD_DEVIATION 10.8 • n=105 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
12 Participants
n=17 Participants
|
22 Participants
n=28 Participants
|
71 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=28 Participants
|
34 Participants
n=105 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
17 Participants
n=17 Participants
|
28 Participants
n=28 Participants
|
105 Participants
n=105 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=105 Participants
|
|
Region of Enrollment
Botswana
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
17 participants
n=17 Participants
|
28 participants
n=28 Participants
|
105 participants
n=105 Participants
|
|
Non-Directive Support
|
4.4 units on a scale
STANDARD_DEVIATION 1.0 • n=25 Participants • 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
|
4.6 units on a scale
STANDARD_DEVIATION 0.7 • n=30 Participants • 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
|
4.8 units on a scale
STANDARD_DEVIATION 0.3 • n=3 Participants • 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=12 Participants • 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
|
4.6 units on a scale
STANDARD_DEVIATION 0.8 • n=70 Participants • 2 intervention patients did not complete baseline survey and could not be reached after multiple attempts. An additional 3 intervention patients declined to respond to this item. Treatment partner non-directive support was only asked of the N=15 treatment partners who were (a) HIV-positive and (b) reported that the patient is also their treatment partner.
|
|
Viral Suppression
|
0 Participants
n=30 Participants • Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible.
|
0 Participants
n=30 Participants • Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible.
|
0 Participants
Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible.
|
0 Participants
Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible.
|
0 Participants
n=60 Participants • Patients were not virally suppressed at baseline per eligibility criteria. Treatment partner viral suppression data was not collected from medical records as was done for patients. Note that treatment partners did not have to be HIV-positive to be eligible.
|
|
Self-reported Adherence
|
18 Participants
n=28 Participants • 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item.
|
23 Participants
n=29 Participants • 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item.
|
6 Participants
n=7 Participants • 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item.
|
10 Participants
n=11 Participants • 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item.
|
57 Participants
n=75 Participants • 2 intervention patients did not complete the baseline survey and could not be reached after multiple attempts. One control patient declined to respond to this item. Treatment partner adherence was asked only of treatment partners who were HIV-positive (treatment partners did not have to be HIV-positive to be eligible.) One HIV-positive control treatment partner and one HIV-positive intervention treatment partner declined to respond to this item.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Viral load was collected from medical records of previous clinic visits. Viral load was only used in analysis if the participant had a viral load measurement between 90 and 180 days after the baseline survey and, if an intervention participant, after the last intervention session. Because medical records often did not include a viral load measurement in the required date range, viral suppression was not available for all participants.
Viral suppression will be defined as viral load \< 400 cp/ml
Outcome measures
| Measure |
Intervention Patients
n=18 Participants
Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
Mopati: The intervention will provide training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners. The Mopati program will provide education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Patients
n=16 Participants
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
|---|---|---|
|
Viral Suppression of Patient Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 3-months post-baselineParticipants self-reported the percentage of doses taken in the past month; we defined treatment adherence as having taken at least 95% of prescribed doses
Outcome measures
| Measure |
Intervention Patients
n=27 Participants
Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
Mopati: The intervention will provide training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners. The Mopati program will provide education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Patients
n=30 Participants
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
|---|---|---|
|
Number of Patient Participants Self-Reported as Treatment Adherent
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 3-months post-baselinePopulation: Some participants skipped the scale on the survey assessment
Continuous scores on Nondirective Support scale (0-5); higher = more nondirective support, rated by patient participants
Outcome measures
| Measure |
Intervention Patients
n=21 Participants
Unsuppressed HIV patients at the intervention clinic will receive guidance from their health care provider on the selection of a treatment partner. The patient and treatment partner will receive education on HIV treatment and how treatment partners can support patients in treatment adherence.
Mopati: The intervention will provide training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners. The Mopati program will provide education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.
|
Control Patients
n=30 Participants
Patients at the control clinic will receive standard of care at the clinic during the intervention assessment period.
|
|---|---|---|
|
Perceived Treatment Partner Support
|
4.9 units on a scale
Standard Deviation 0.2
|
4.5 units on a scale
Standard Deviation 1.0
|
Adverse Events
Intervention
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
Intervention - Treatment Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Treatment Partners
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