Tuberculosis, Tuberculosis, Pulmonary
Conditions
Brief 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.
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.
Interventions
BEHAVIORALUser-Centered Implementation Strategy
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.
BEHAVIORALStandard 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Blinding of the assigned intervention is not feasible with the stepped-wedge cluster randomized implementation trial design, because interventions are implemented at the health-facility level and all health facilities receive the standard strategy followed by the enhanced, user-centered strategy. Community Health Workers will collect all data, and adjudicate all outcomes, except TB diagnoses and treatments initiated which will be collected from on-site National TB and Leprosy Programme registers. Where possible, the investigators and study staff, except for the statistician and data manager, will be blinded to any aggregated analyses of TB outcomes by study period.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of TB Evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Contacts Initiating TB Preventative Therapy | 60 days | The difference between study periods in counts of the number of contacts initiating TPT |
| Initiation of TB Preventative Therapy | 60 days | The difference between study periods in percentage of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation |
| Number of Contacts Diagnosed With Active TB | 60 days | The difference between study periods in counts of the number of contacts diagnosed with active TB |
| TB Yield (Diagnosis and Treatment Initiation) | 60 days | 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 |
| TB Yield (All Contacts) | 60 days | The difference between study periods in percentage of all TB cases among contacts |
Countries
Uganda
Participant flow
Pre-assignment details
In this stepped-wedge, cluster-randomized trial, 12 health facilities progress from Standard Contact Investigation \[Control\] to User-centered Contact Investigation \[Intervention\] in 6 clusters of randomly assigned pairs that cross over one cluster at a time \[Sequences\] at randomly assigned 8-week intervals \[Periods\]. All clusters start in Standard for 8 weeks, then 1 cluster crosses over to User-centered every 8 weeks for 48 weeks, and finally all clusters are in User-centered for 8 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Standard Contact Investigation: Index Participants Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
Standard contact investigation:
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.
Standard Implementation Strategy:
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. | 843 |
| Standard Contact Investigation: Household Contacts Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
Standard contact investigation:
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.
Standard Implementation Strategy:
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. | 2,874 |
| User-centered Contact Investigation: Index Participants User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
Sputum collection video to instruct contacts to expectorate good-quality sputum.
Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
CHW-centered Implementation Strategy: Three components Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
A group-chat application to facilitate peer support among CHWs. | 999 |
| User-centered Contact Investigation: Household Contacts User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
Sputum collection video to instruct contacts to expectorate good-quality sputum.
Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
CHW-centered Implementation Strategy: Three components Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
A group-chat application to facilitate peer support among CHWs. | 5,761 |
| Total | 10,477 |
Baseline characteristics
| Characteristic | Standard Contact Investigation: Index Participants | Total | User-centered Contact Investigation: Household Contacts | User-centered Contact Investigation: Index Participants | Standard Contact Investigation: Household Contacts |
|---|---|---|---|---|---|
| Age, Customized ≥15 years | 711 Participants | 6864 Participants | 3510 Participants | 887 Participants | 1756 Participants |
| Age, Customized 5-14 years | 51 Participants | 2511 Participants | 1603 Participants | 49 Participants | 808 Participants |
| Age, Customized <5 years | 81 Participants | 1102 Participants | 648 Participants | 63 Participants | 310 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 843 Participants | 10477 Participants | 5761 Participants | 999 Participants | 2874 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Person living with HIV | 343 participants | 1181 participants | 235 participants | 461 participants | 142 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 843 Participants | 10477 Participants | 5761 Participants | 999 Participants | 2874 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 843 participants | 10477 participants | 5761 participants | 999 participants | 2874 participants |
| Sex: Female, Male Female | 379 Participants | 5372 Participants | 2987 Participants | 415 Participants | 1591 Participants |
| Sex: Female, Male Male | 464 Participants | 5105 Participants | 2774 Participants | 584 Participants | 1283 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 85 | 0 / 1,516 | 0 / 650 | 0 / 1,983 | 0 / 516 | 0 / 1,663 | 0 / 471 | 0 / 841 | 0 / 669 | 0 / 443 | 0 / 1,326 | 0 / 314 |
| serious Total, serious adverse events | 0 / 85 | 0 / 1,516 | 0 / 650 | 0 / 1,983 | 0 / 516 | 0 / 1,663 | 0 / 471 | 0 / 841 | 0 / 669 | 0 / 443 | 0 / 1,326 | 0 / 314 |
Outcome results
Primary
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
Time frame: 60 days
Population: Only those who screened positive for symptoms of TB are included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | Completion of TB Evaluation | 266 Participants |
| Enhanced Contact Investigation Intervention Period | Completion of TB Evaluation | 1144 Participants |
p-value: <0.00195% CI: [1.62, 2.09]Mixed Models Analysis
Secondary
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
Time frame: 60 days
Population: Only those eligible for TPT are included in this analysis. Those that have been newly diagnosed with TB, regardless of treatment status, are not eligible for TPT and are therefore excluded from this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | Initiation of TB Preventative Therapy | 122 Participants |
| Enhanced Contact Investigation Intervention Period | Initiation of TB Preventative Therapy | 264 Participants |
p-value: 0.595% CI: [0.65, 2.42]Mixed Models Analysis
Secondary
Number of Contacts Diagnosed With Active TB
The difference between study periods in counts of the number of contacts diagnosed with active TB
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | Number of Contacts Diagnosed With Active TB | 45 Participants |
| Enhanced Contact Investigation Intervention Period | Number of Contacts Diagnosed With Active TB | 201 Participants |
Secondary
Number of Contacts Initiating TB Preventative Therapy
The difference between study periods in counts of the number of contacts initiating TPT
Time frame: 60 days
Population: This outcome is only for those eligible to initiate TPT. Those who have been newly diagnosed, regardless of treatment status, are not eligible for TPT and are therefore excluded from this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | Number of Contacts Initiating TB Preventative Therapy | 122 Participants |
| Enhanced Contact Investigation Intervention Period | Number of Contacts Initiating TB Preventative Therapy | 264 Participants |
Secondary
TB Yield (All Contacts)
The difference between study periods in percentage of all TB cases among contacts
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | TB Yield (All Contacts) | 45 Participants |
| Enhanced Contact Investigation Intervention Period | TB Yield (All Contacts) | 201 Participants |
p-value: <0.00195% CI: [2.07, 10.91]Mixed Models Analysis
Secondary
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
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Implementation Strategy Period | TB Yield (Diagnosis and Treatment Initiation) | 36 Participants |
| Enhanced Contact Investigation Intervention Period | TB Yield (Diagnosis and Treatment Initiation) | 187 Participants |
p-value: 0.00295% CI: [2.06, 26.95]Mixed Models Analysis