Tuberculosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTScreening at community level
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Zambia
Outcome results
None listed