Trial Outcomes & Findings for Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers (NCT NCT05938621)
NCT ID: NCT05938621
Last Updated: 2025-09-22
Results Overview
We assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28448 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-22
Participant Flow
We recruited 25 health care workers from each of four health facilities. Health care workers consented to participate and interacted with the study team. All eligible patients who they treated during the subsequent 6 months were included in the clinical outcome data.
Unit of analysis: Clinics
Participant milestones
| Measure |
Standard of Care
Health care providers in this arm will receive no intervention
|
Resilience Intervention
Providers in this arm will receive training to improve their resilience and well-being
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Resilience and Stigma Group
Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Anti-stigma Group
Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25 1
|
25 1
|
25 1
|
25 1
|
|
Overall Study
Number of Patients Receiving Care
|
4597 1
|
12904 1
|
6324 1
|
4523 1
|
|
Overall Study
COMPLETED
|
24 1
|
20 1
|
23 1
|
23 1
|
|
Overall Study
NOT COMPLETED
|
1 0
|
5 0
|
2 0
|
2 0
|
Reasons for withdrawal
| Measure |
Standard of Care
Health care providers in this arm will receive no intervention
|
Resilience Intervention
Providers in this arm will receive training to improve their resilience and well-being
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Resilience and Stigma Group
Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Anti-stigma Group
Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
2
|
2
|
Baseline Characteristics
These data are from the 100 providers that were enrolled in the study
Baseline characteristics by cohort
| Measure |
Standard of Care
n=4622 Participants
Health care providers in this arm will receive no intervention
|
Resilience Intervention
n=12929 Participants
Providers in this arm will receive training to improve their resilience and well-being
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Resilience and Stigma Group
n=6349 Participants
Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Anti-stigma Group
n=4548 Participants
Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Total
n=28448 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 10.60 • n=4597 Participants • This is the data from patients only.
|
29.7 years
STANDARD_DEVIATION 18.86 • n=12904 Participants • This is the data from patients only.
|
32.11 years
STANDARD_DEVIATION 10.49 • n=6324 Participants • This is the data from patients only.
|
30.6 years
STANDARD_DEVIATION 10.11 • n=4523 Participants • This is the data from patients only.
|
30.8 years
STANDARD_DEVIATION 14.91 • n=28348 Participants • This is the data from patients only.
|
|
Sex: Female, Male
Female
|
3044 Participants
n=4597 Participants • These data only include patients seen at the study clinics
|
9058 Participants
n=12904 Participants • These data only include patients seen at the study clinics
|
4379 Participants
n=6324 Participants • These data only include patients seen at the study clinics
|
2926 Participants
n=4523 Participants • These data only include patients seen at the study clinics
|
19407 Participants
n=28348 Participants • These data only include patients seen at the study clinics
|
|
Sex: Female, Male
Male
|
1553 Participants
n=4597 Participants • These data only include patients seen at the study clinics
|
3846 Participants
n=12904 Participants • These data only include patients seen at the study clinics
|
1945 Participants
n=6324 Participants • These data only include patients seen at the study clinics
|
1597 Participants
n=4523 Participants • These data only include patients seen at the study clinics
|
8941 Participants
n=28348 Participants • These data only include patients seen at the study clinics
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4622 Participants
n=4622 Participants
|
12929 Participants
n=12929 Participants
|
6349 Participants
n=6349 Participants
|
4548 Participants
n=4548 Participants
|
28448 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4622 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Region of Enrollment
Mozambique
|
4622 participants
n=4622 Participants
|
12929 participants
n=12929 Participants
|
6349 participants
n=6349 Participants
|
4548 participants
n=4548 Participants
|
28448 participants
n=28448 Participants
|
|
Number of Years Working in this Health Facility
|
3.4 years
STANDARD_DEVIATION 1.95 • n=25 Participants • This only includes provider data
|
6.1 years
STANDARD_DEVIATION 6.05 • n=25 Participants • This only includes provider data
|
5.5 years
STANDARD_DEVIATION 3.70 • n=25 Participants • This only includes provider data
|
4.2 years
STANDARD_DEVIATION 3.09 • n=25 Participants • This only includes provider data
|
4.8 years
STANDARD_DEVIATION 4.07 • n=100 Participants • This only includes provider data
|
PRIMARY outcome
Timeframe: 6 monthsWe assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative.
Outcome measures
| Measure |
Standard of Care
n=24 Participants
Health care providers in this arm will receive no intervention
|
Resilience Intervention
n=20 Participants
Providers in this arm will receive training to improve their resilience and well-being
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Resilience and Stigma Group
n=23 Participants
Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
Anti-stigma Group
n=23 Participants
Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed.
Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
|
|---|---|---|---|---|
|
Burnout
|
-2.0 units on a scale
Interval -10.9 to 9.5
|
-5.9 units on a scale
Interval -8.2 to -2.0
|
-5.3 units on a scale
Interval -13.8 to 2.0
|
-3.9 units on a scale
Interval -13.8 to 2.0
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resilience Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resilience and Stigma Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anti-stigma Group
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