Introduction
Background and rationale
Objectives
Trial design
Methods: participants, interventions, and outcomes
Study setting
Eligibility criteria
- Pulmonary TB: a cough for more than 2 weeks and at least one general symptom
- Extra-pulmonary TB: presence of symptoms, depending on the location of TB (e.g., enlarged lymph node, swollen backbone, swollen articulation, etc.), and at least one general symptom
- General symptoms: fever, night sweats for more than 2 weeks, or unintentional weight loss (> 5% reduction in usual body weight over the last 6–12 months) [27]
Who will take informed consent?
Additional consent provisions for collection and use of participant data and biological specimens
Interventions
Explanation for the choice of comparators
Intervention description
Criteria for discontinuing or modifying allocated interventions
Strategies to improve adherence to interventions
Relevant concomitant care permitted or prohibited during the trial
Provisions for post-trial care
Outcomes
Participant timeline
Timepoint | Study period | ||||||||
---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | |||||||
2019 | 2019 | 2019 | 2020 | 2020 | 2020 | 2020 | 2021 | 2021 | |
Q3 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | |
Enrollment (cluster level) | |||||||||
Assessment of cluster | X | ||||||||
Randomization of cluster | X | ||||||||
Allocation of intervention | X | ||||||||
Interventions | |||||||||
Active case finding with a seed-and-recruit model | X | X | X | X | X | ||||
Active case finding targeting household and neighborhood contacts | X | X | X | X | X | ||||
Active case finding targeting people aged 55 years and older using mobile screening units | X | X | X | X | X | ||||
Passive case finding | X | X | X | X | X | ||||
Assessments (cluster level) | |||||||||
TB case notification by selected clusters | X | X | X | X | X | ||||
TB cases reported by each arm | X | X | X | X | X | ||||
Individuals screened for TB | X | X | X | X | X | ||||
Treatment outcomes | X | X | X | X | X | ||||
Cost data | X | X | X | X | X | X | X | ||
Assessments (individual level) | |||||||||
Enrollment | X | X | X | X | X | ||||
Baseline survey | X | X | X | X | X | ||||
Follow-up survey | X | X | X | X | X |
Sample size
Recruitment
Assignment of interventions: allocation
Sequence generation
Concealment mechanism
Implementation
Assignment of interventions: blinding
Who will be blinded
Procedure for unblinding if needed
Data collection and management
Plans for assessment and collection of outcomes
Study endpoint | Description | Data source |
---|---|---|
Primary endpoints | ||
Case notification rates (cases notified per 10,000 population per year) | Numerator: number of cases notified by the selected districts | Case notification data from CENAT |
Denominator: total population in the OD | Population statistics (Ministry of Planning/Department of Statistics/CENAT) | |
Additionality (additional number of cases reported compared to historical baseline) | Number of cases notified by the selected districts | Case notification data from CENAT |
Historical data (cases notified in the preceding 3 years) | Historical case notification data from CENAT | |
Cumulative yield (cases diagnosed per 1000 screened) | Numerator: number of cases reported by each arm | Program data In the control arm, data to be collected from the health centers monthly |
Denominator: total number of individuals screened | Program data Provincial health department laboratory data to determine the number of people screened at health centers in the control arm | |
Secondary endpoints | ||
Treatment outcomes | TB treatment outcomes of all new patients 6 months after treatment initiation | Health centers |
Number needed to screen | Numerator: total number of individuals screened | Program data Provincial health department laboratory data to determine the number of people screened at health centers in the control arm |
Denominator: number of cases reported by each arm | Program data Control arm: data to be collected from the health centers monthly | |
Cost per TB case diagnosed/notified | Direct and indirect medical costs while seeking care for TB Staff and intervention costs Diagnostics and medication costs | Health-care-seeking costs: data to be collected in the baseline and follow-up survey Intervention costs: data to be collected from KHANA, CENAT, and CATA DALYs: data to be extracted from WHO global burden of disease studies and other existing literature |
Incremental cost-effectiveness ratio per DALY averted |