Achieving Tuberculosis (TB) Control In Zambia

Study Overview
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Brief Summary
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To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.

Detailed Description
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The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control. The interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.

Official Title
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Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions

Conditions
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Tuberculosis

Intervention / Treatment
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* Diagnostic Test: Screening at community level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Program Implementation: Inclusion criteria: Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats) Ability to produce sputum Verbal consent of parent or guardian if < 18 years old Operations Research: Inclusion criteria Adults (18 years and older) TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats) Ability to provide a sputum sample Willing to provide written informed consent Willing to undergo full clinical evaluation Willing to undergo a CXR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Community level screening; Arm 1<br>use of chest X-ray plus Xpert Ultra for community level TB screening | Diagnostic Test: Screening at community level<br>* comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening<br>|
| Active Comparator: Community level screening: Arm 2<br>use of C-reactive Protein and Xpert Ultra for community level TB screening | Diagnostic Test: Screening at community level<br>* comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase TB case detection | comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection | 6 months |