Achieving Tuberculosis (TB) Control In Zambia

Tuberculosis Clinical Trial

— TB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497195
• Other study ID #: IRB-300001132
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18194
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• Screening at community level
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening

Locations

Country	Name	City	State
Zambia	Center for Infectious Disease Research in Zambia (CIDRZ)	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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