N/A
Completed N=3,332
A Clinical Risk Score for Early Management of TB in Uganda
Tuberculosis, Pulmonary
Source: ClinicalTrials.gov NCT05122624 ↗
Enrolled (actual)
3,332
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Difference in 7-day Treatment Initiation From Pre-implementation to Post-implementation — 1; -13 percentage of participants
Summary
Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in 7-day Treatment Initiation From Pre-implementation to Post-implementation |
1; -13 | — |
| PRIMARY Implementation: Percentage of Encountered Patients at Intervention Arm Who Initiated the Same-day Treatment Based on PredicTB Score as Indicated |
46 | — |
| SECONDARY Incremental Cost-effectiveness of PredicTB |
— | — |
| SECONDARY Difference in TB Mortality From Pre-implementation to Post-implementation |
-1; -1 | — |
| SECONDARY Difference in Loss to Care From Pre-implementation To Post-implementation |
1; 1 | — |
| SECONDARY Difference in Percentage of Participants With Microbiologically Confirmed TB |
14; 0 | — |
| SECONDARY Reach: Percentage of Patients Who Were Administered (or Evaluated) by PredicTB Score |
66 | — |
| SECONDARY Adoption: Percentage of Providers Adopting PredicTB |
100 | — |
| SECONDARY Maintenance: Change in Effectiveness Over Time in the Post-implementation Phase at Intervention Arm |
-16 | — |
| SECONDARY Modeled Changes in 5-year Mortality With PredicTB |
— | — |
Eligibility Criteria
Inclusion Criteria
- All adult patients submitting sputum for a new diagnosis of pulmonary TB in the four study clinics and four comparison clinics between month -6 and month 18 will have their records abstracted by study staff.
- Starting in the 13th month after PredicTB implementation (i.e., after the 12-month post-implementation period has ended), study staff will position themselves in the four study clinics for purposes of recruiting and enrolling adult patients submitting sputum for a new diagnosis of pulmonary TB. No exclusions will be made except for age (as above), and we will seek to enroll all consecutive patients until our target sample size (25 participants per clinic, total n = 100) has been reached.
Exclusion Criteria
- Age < 15 years old
Data sourced from ClinicalTrials.gov (NCT05122624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.