N/A
Completed N=913
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
Tuberculosis · Tuberculosis, Pulmonary
Source: ClinicalTrials.gov NCT05640648 ↗
Enrolled (actual)
913
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Completion of TB Evaluation — 266; 1144 Participants — p=<0.001
Summary
In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade. Drawing on prior experiences, the investigators have recently developed a novel strategy to enhance the implementation of routine contact investigation procedures. This user-centered implementation strategy was created through serial prototyping guided by human-centered design (HCD) and employs communities of practice (CoP) as an adjunctive adaptation and sustainment strategy. The investigators are now conducting a stepped-wedge, cluster-randomized implementation trial in 12 study sites in Uganda to determine if the resulting user-centered implementation strategy enhances the delivery of TB contact investigation and other implementation outcomes, and also improves health outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of TB Evaluation |
266; 1144 | <0.001 sig |
| SECONDARY TB Yield (Diagnosis and Treatment Initiation) |
36; 187 | 0.002 sig |
| SECONDARY Initiation of TB Preventative Therapy |
122; 264 | 0.50 |
| SECONDARY Number of Contacts Diagnosed With Active TB |
45; 201 | — |
| SECONDARY Number of Contacts Initiating TB Preventative Therapy |
122; 264 | — |
| SECONDARY TB Yield (All Contacts) |
45; 201 | <0.001 sig |
Eligibility Criteria
Health centre inclusion criteria:
- Reporting ≥12 index TB cases per month to the national TB program,
- Located outside the borders of but ≤180 km from Kampala District
Health centre exclusion criteria:
- Administrators of the health centre do not agree to participate in the study
Individual inclusion criteria for index persons with TB (also known as index TB patients or TB cases):
- Being an adult or child recorded as a new TB case in the on-site National TB and Leprosy Programme TB treatment register, and
- Residing ≤40 km from the enrolling health centre,
Individual exclusion criteria for index persons with TB :
- Lacking the capacity to consent to contact investigation,
- Lacking close contacts,
- Having possible or confirmed drug-resistant TB,
- Previously received TB contact investigation within the last 2 months, and
- Not agreeing to refer close contacts for contact investigation.
Inclusion criteria for close contacts:
- Being an adult or child reporting ≥12 cumulative hours with the TB patient inside an enclosed space within the previous 3 months,
Exclusion criteria for close contacts:
- Lacking the capacity to consent to contact investigation,
- Currently taking treatment for active TB, and
- Not agreeing to participate in contact investigation.
Data sourced from ClinicalTrials.gov (NCT05640648). 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.