At a glance
ClinicalIndex Comparison Record- ✓Health centre reports ≥12 index TB cases per month to the national TB program
- ✓Health centre located ≤180 km from Kampala District
- ✓Index TB patient is a new TB case recorded in the National TB and Leprosy Programme register
- ✓Index TB patient resides ≤40 km from the enrolling health centre
- ✕Health centre administrators do not agree to participate
- ✕Index TB patient lacks capacity to consent to contact investigation
- ✕Index TB patient has no close contacts
- ✕Index TB patient has possible or confirmed drug-resistant TB
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda
In Brief
A clinical study evaluating User-Centered Implementation Strategy and Standard Implementation Strategy for Tuberculosis and Tuberculosis, Pulmonary. Completed, enrolled 10,477 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
1. 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum. 2. 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. Meetings involve problem solving, review of audit and feedback reports, and didactics on TB care, among other activities. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.