Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

Tuberculosis Clinical Trial

— HCD CoP  

Official title:

Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640648
• Other study ID #: R01AI104824
• Secondary ID: 5R01AI104824R01A
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: October 26, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The trial has 3 major aims: (1) to compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced, "user-centered" implementation strategy versus a standard implementation strategy in a stepped-wedge, cluster-randomized implementation trial; (2) to identify processes and contextual factors that influence the implementation, effectiveness, and public health impact of the enhanced delivery strategy for TB contact investigation; and (3) to compare the costs and epidemiological impact of the enhanced and standard implementation strategies for TB contact investigation. The enhanced, user-centered strategy will employ two major components: a) a branded, participant-centered strategy consisting of implementation facilitation tools previously developed using human-centered design; and b) Communities of Practice, a community-health worker-centered, continuous quality improvement strategy. The goal is to improve the delivery of standard TB contact investigation following Uganda National TB & Leprosy Programme guidelines. The investigators hypothesize that the enhanced, user-centered strategy will result in a greater proportion of close contacts completing TB evaluation than the standard strategy. They further hypothesize that successful implementation will be deemed feasible, acceptable, and appropriate by patients and CHWs and that it will increase self-efficacy and perceived social support among CHWs. Finally, the investigators hypothesize that models evaluating the impact of the user-centered strategy when delivered nationwide will find it cost-effective and able to reduce national TB incidence over a 10-year horizon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10477
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Health centre inclusion criteria:

1. Reporting =12 index TB cases per month to the national TB program,

2. Located outside the borders of but =180 km from Kampala District

Health centre exclusion criteria:

1) 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):

1. Being an adult or child recorded as a new TB case in the on-site National TB and Leprosy Programme TB treatment register, and

2. Residing =40 km from the enrolling health centre,

Individual exclusion criteria for index persons with TB :

1. Lacking the capacity to consent to contact investigation,

2. Lacking close contacts,

3. Having possible or confirmed drug-resistant TB,

4. Previously received TB contact investigation within the last 2 months, and

5. Not agreeing to refer close contacts for contact investigation.

Inclusion criteria for close contacts:

1) 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:

1. Lacking the capacity to consent to contact investigation,

2. Currently taking treatment for active TB, and

3. Not agreeing to participate in contact investigation.

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Behavioral:
• User-Centered Implementation Strategy
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. 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.
• Standard Implementation Strategy
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.

Locations

Country	Name	City	State
Uganda	Uganda Tuberculosis Implementation Research Consortium	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of TB Evaluation	The difference in proportions of close contacts who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date	60 days
Secondary	TB Yield (symptomatic contacts)	The difference between study periods in proportions of contacts diagnosed with active TB and initiated on treatment within 60 days of the TB patient's treatment initiation	60 days
Secondary	Initiation of TB Preventative Therapy	The difference between study periods in proportions of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation	60 days
Secondary	Number of contacts diagnosed with active TB	The difference between study periods in counts of the number of contacts diagnosed with active TB	60 days
Secondary	Number of contacts initiating TB Preventative Therapy	The difference between study periods in counts of the number of contacts initiating TPT	60 days
Secondary	TB Yield (all contacts)	The difference between study periods in proportions of all TB cases among contacts	60 days