Trial Outcomes & Findings for A Clinical Risk Score for Early Management of TB in Uganda (NCT NCT05122624)
NCT ID: NCT05122624
Last Updated: 2024-07-23
Results Overview
The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during post-implementation 'minus' The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during pre-implementation
COMPLETED
NA
3332 participants
Up to 12 months post intervention
2024-07-23
Participant Flow
The study was initially conducted in eight primary health clinics (four clinics in the intervention arm and the other four clinics in the control arm). During the study, a total of three clinics (two in the intervention arm and one in the control arm) were replaced with other facilities of similar size and location for the remainder of the study period, resulting in 11 participating clinics.
Unit of analysis: Clinics
Participant milestones
| Measure |
Score Intervention Arm
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Overall Study
STARTED
|
1826 6
|
1506 5
|
|
Overall Study
COMPLETED
|
1826 6
|
1506 5
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One missing in sex at control arm
Baseline characteristics by cohort
| Measure |
Score Intervention Arm
n=6 Clinics
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
n=5 Clinics
The standard of care will be conducted in this arm.
|
Total
n=11 Clinics
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=1826 Participants
|
35 years
n=1506 Participants
|
36 years
n=3332 Participants
|
|
Sex: Female, Male
Female
|
1077 Participants
n=1826 Participants • One missing in sex at control arm
|
834 Participants
n=1505 Participants • One missing in sex at control arm
|
1911 Participants
n=3331 Participants • One missing in sex at control arm
|
|
Sex: Female, Male
Male
|
749 Participants
n=1826 Participants • One missing in sex at control arm
|
671 Participants
n=1505 Participants • One missing in sex at control arm
|
1420 Participants
n=3331 Participants • One missing in sex at control arm
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Uganda
|
1826 Participants
n=1826 Participants
|
1506 Participants
n=1506 Participants
|
3332 Participants
n=3332 Participants
|
|
HIV status
Positive
|
857 Participants
n=1826 Participants
|
684 Participants
n=1506 Participants
|
1541 Participants
n=3332 Participants
|
|
HIV status
Negative
|
760 Participants
n=1826 Participants
|
741 Participants
n=1506 Participants
|
1501 Participants
n=3332 Participants
|
|
HIV status
Unknown/Missing
|
209 Participants
n=1826 Participants
|
81 Participants
n=1506 Participants
|
290 Participants
n=3332 Participants
|
|
Sputum specimen submitted
|
1348 Participants
n=1826 Participants
|
1007 Participants
n=1506 Participants
|
2355 Participants
n=3332 Participants
|
|
Microbiologically confirmed TB
|
173 Participants
n=1826 Participants
|
138 Participants
n=1506 Participants
|
311 Participants
n=3332 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post interventionPopulation: This outcome includes individuals who were diagnosed with tuberculosis.
The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during post-implementation 'minus' The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during pre-implementation
Outcome measures
| Measure |
Score Intervention Arm
n=1036 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
n=574 Participants
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Difference in 7-day Treatment Initiation From Pre-implementation to Post-implementation
|
1 percentage of participants
Interval -6.0 to 8.0
|
-13 percentage of participants
Interval -22.0 to -5.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: This outcome includes individuals who presented TB symptoms. This outcome is relevant to intervention arm only.
Percentage of patients who initiated same-day treatment divided by the number of patients who had a higher PredicTB score than the clinic-specific score of treatment threshold in the post-implementation period in intervention arm
Outcome measures
| Measure |
Score Intervention Arm
n=229 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Implementation: Percentage of Encountered Patients at Intervention Arm Who Initiated the Same-day Treatment Based on PredicTB Score as Indicated
|
46 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Months 0 - 12Population: Data was not collected.
(cost of implementing PredicTB - cost of standard of care)/(projected disability-adjusted life years (DALYs) in standard of care - projected DALYs with PredicTB)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 MonthsPopulation: This outcome includes individuals who were diagnosed with tuberculosis.
The percentage of participants with microbiologically confirmed TB who died of any cause in the post-implementation "minus" The percentage of participants with microbiologically confirmed TB who died of any cause in the pre-implementation
Outcome measures
| Measure |
Score Intervention Arm
n=1036 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
n=574 Participants
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Difference in TB Mortality From Pre-implementation to Post-implementation
|
-1 percentage of participants
Interval -4.0 to 1.0
|
-1 percentage of participants
Interval -6.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: This outcome includes individuals who were diagnosed with tuberculosis.
The percentage of participants with microbiologically confirmed TB who were lost to follow-up in the post-implementation "minus" The percentage of participants with microbiologically confirmed TB who were lost to follow-up in the pre-implementation
Outcome measures
| Measure |
Score Intervention Arm
n=1036 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
n=574 Participants
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Difference in Loss to Care From Pre-implementation To Post-implementation
|
1 percentage of participants
Interval -3.0 to 2.0
|
1 percentage of participants
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 12 months post-implementationPopulation: This outcome includes individuals who were diagnosed with tuberculosis.
Difference in the percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days from post-implementation to pre-implementation at intervention arm "minus" Difference in the percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days from post-implementation to pre-implementation at comparison arm
Outcome measures
| Measure |
Score Intervention Arm
n=1036 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
n=574 Participants
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Difference in Percentage of Participants With Microbiologically Confirmed TB
|
14 percentage of participants
Interval 10.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: This outcome includes individuals who presented TB symptoms. This outcome is relevant to intervention arm only.
Percentage of patients who were administered (or evaluated) by PredicTB score among those who presented presumptive TB symptoms at clinics in the post-implementation period in intervention arm
Outcome measures
| Measure |
Score Intervention Arm
n=1826 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Reach: Percentage of Patients Who Were Administered (or Evaluated) by PredicTB Score
|
66 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 18Population: This outcome analysis is relevant to intervention arm only. Per protocol, healthcare providers were not considered enrolled.
Percentage of providers using PredicTB in over 50% of encounters in which sputum is submitted for pulmonary TB diagnosis among those seeing \>5 patients who submit sputum for diagnosis of pulmonary TB
Outcome measures
| Measure |
Score Intervention Arm
n=17 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Adoption: Percentage of Providers Adopting PredicTB
|
100 percentage of providers
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: This outcome is relevant to intervention arm only
Percentage of participants with microbiologically confirmed TB who initiated treatment within seven days in the post-implementation phase at intervention arm "minus" Percentage of participants with microbiologically confirmed TB who initiated treatment within seven days in the post-implementation phase at intervention arm
Outcome measures
| Measure |
Score Intervention Arm
n=165 Participants
The PredicTB score will be implemented in this arm.
PredicTB score: This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10.
We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.
|
Control Arm
The standard of care will be conducted in this arm.
|
|---|---|---|
|
Maintenance: Change in Effectiveness Over Time in the Post-implementation Phase at Intervention Arm
|
-16 percentage of participants
Interval -31.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: Data was not collected.
Modeled hypothetical, expected changes in mortality at year 5, comparing simulations in which PredicTB is implemented to those in which PredicTB is not implemented, using a Markov state-transition model
Outcome measures
Outcome data not reported
Adverse Events
Score Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yeonsoo Baik
Johns Hopkins Bloomberg School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place