TuberculosisHCD-CoPNCT05640648
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
A study testing User-Centered Implementation Strategy and Standard Implementation Strategy in people with Tuberculosis and Tuberculosis, Pulmonary, run by Yale University at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary
- What is being tested?
- User-Centered Implementation Strategy and Standard Implementation Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,477 participants
- Where
- 1 siteUganda
- Study dates
- 7 Mar 2022to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1) Being an adult or child reporting ≥12 cumulative hours with the TB patient inside an enclosed space within the previous 3 months,
Who cannot join
- Lacking the capacity to consent to contact investigation,
- Currently taking treatment for active TB, and
- Not agreeing to participate in contact investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda
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.
Read the detailed 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.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Being tested
- User-Centered Implementation Strategy, Standard Implementation Strategy
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
User-Centered Implementation StrategyBehavioural
Also called Enhanced Contact Investigation 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 StrategyBehavioural
Also called Usual 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation Strategy Period | Active comparator | 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. Receives: Behavioral: Standard Implementation Strategy |
| Enhanced Contact Investigation Intervention Period | Experimental | The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques and will be delivered as a branded package named for an inspirational Luganda phrase that is translated as "We are together with you." Implementation facilitation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application. Receives: Behavioral: User-Centered Implementation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of TB Evaluation
The percentage of participants (close contacts) who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date
Measured: 60 days
Secondary outcomes (5)
TB Yield (Diagnosis and Treatment Initiation)
The difference between study periods in percentage of contacts diagnosed with active TB and initiated on treatment within 60 days of the TB patient's treatment initiation
Measured: 60 days
Initiation of TB Preventative Therapy
The difference between study periods in percentage of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation
Measured: 60 days
Number of Contacts Diagnosed With Active TB
The difference between study periods in counts of the number of contacts diagnosed with active TB
Measured: 60 days
Number of Contacts Initiating TB Preventative Therapy
The difference between study periods in counts of the number of contacts initiating TPT
Measured: 60 days
TB Yield (All Contacts)
The difference between study periods in percentage of all TB cases among contacts
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start7 Mar 2022
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will conduct a stepped-wedge, cluster-randomized implementation trial with nested mixed-methods evaluations of fidelity and context and health economic analyses. The stepped-wedge trial will include six transition steps in a complete (also known as closed) design, providing a 1:1 ratio of time periods allocated to the pre-implementation standard strategy and the post-implementation user-centered strategy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10,477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Lucian Davis, MD, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640648
- Sponsor's protocol ID
- R01AI104824
- Other IDs
- 5R01AI104824, R01AI104824, 2000023199
- Acronym
- HCD-CoP
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2022
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication upon request
Publications
Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: protocol for a stepped-wedge, cluster-randomised trial. BMC Public Health. 2023 Aug 17;23(1):1568. doi: 10.1186/s12889-023-16510-0.
PubMed 37592314Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: Protocol for a stepped-wedge, cluster-randomised trial. Res Sq [Preprint]. 2023 Jul 6:rs.3.rs-3121275. doi: 10.21203/rs.3.rs-3121275/v1.
PubMed 37461631
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda
- ClinicalTrials.gov ID
- NCT05640648
- Acronym / sponsor ID
- HCD-CoP / R01AI104824
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,477 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a stepped-wedge, cluster-randomized implementation trial with nested mixed-methods evaluations of fidelity and context and health economic analyses. The stepped-wedge trial will include six transition steps in a complete (also known as closed) design, providing a 1:1 ratio of time periods allocated to the pre-implementation standard strategy and the post-implementation user-centered strategy.
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation Strategy Period | Active comparator | Behavioral: Standard Implementation StrategyDuring 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. |
| Enhanced Contact Investigation Intervention Period | Experimental | Behavioral: User-Centered Implementation StrategyThe enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques and will be delivered as a branded package named for an inspirational Luganda phrase that is translated as "We are together with you." Implementation facilitation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Being an adult or child reporting ≥12 cumulative hours with the TB patient inside an enclosed space within the previous 3 months,
Key exclusion criteria (3 listed)
- Lacking the capacity to consent to contact investigation,
- Currently taking treatment for active TB, and
- Not agreeing to participate in contact investigation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| User-Centered Implementation StrategyAlso: Enhanced Contact Investigation Implementation Strategy1. 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. | Behavioural | Enhanced Contact Investigation Intervention Period |
| Standard Implementation StrategyAlso: Usual Implementation StrategyOnce 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. | Behavioural | Standard Implementation Strategy Period |
Primary outcome
Completion of TB Evaluation
Time frame: 60 days
The percentage of participants (close contacts) who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date
5 secondary outcomes
TB Yield (Diagnosis and Treatment Initiation)
Time frame: 60 days
Initiation of TB Preventative Therapy
Time frame: 60 days
Number of Contacts Diagnosed With Active TB
Time frame: 60 days
Number of Contacts Initiating TB Preventative Therapy
Time frame: 60 days
TB Yield (All Contacts)
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37592314Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: protocol for a stepped-wedge, cluster-randomised trial. BMC Public Health. 2023 Aug 17;23(1):1568. doi: 10.1186/s12889-023-16510-0.
- Derived from this study: PubMed 37461631Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: Protocol for a stepped-wedge, cluster-randomised trial. Res Sq [Preprint]. 2023 Jul 6:rs.3.rs-3121275. doi: 10.21203/rs.3.rs-3121275/v1.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Lucian Davis, MD principal investigator
Yale School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing User-Centered Implementation Strategy and Standard Implementation Strategy in people with Tuberculosis and Tuberculosis, Pulmonary, run by Yale University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of TB Evaluation (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05640648, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.