Achieving Tuberculosis (TB) Control In Zambia

The University of Alabama at Birmingham

Status: Completed

Conditions: Tuberculosis

Treatments: Diagnostic Test: Screening at community level

Study type: Interventional

Funder types: Other

Identifiers

NCT03497195

IRB-300001132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18,194 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

18,194 participants in 2 patient groups

Community level screening; Arm 1

Active Comparator group

Description:

use of chest X-ray plus Xpert Ultra for community level TB screening

Treatment:

Diagnostic Test: Screening at community level

Community level screening: Arm 2

Active Comparator group

Description:

use of C-reactive Protein and Xpert Ultra for community level TB screening

Treatment:

Diagnostic Test: Screening at community level