Achieving Tuberculosis (TB) Control In Zambia

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Diagnostic Test: Screening at community level

• Registration Number: NCT03497195
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18194

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Community level screening; Arm 1	Screening at community level	use of chest X-ray plus Xpert Ultra for community level TB screening
Community level screening: Arm 2	Screening at community level	use of C-reactive Protein and Xpert Ultra for community level TB screening

Primary Outcome Measures

Name	Time	Method
increase TB case detection	6 months	comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection

Trial Locations

Locations (1)

Center for Infectious Disease Research in Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia