Achieving Tuberculosis (TB) Control In Zambia (TB)
Primary Purpose
Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Screening at community level
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility 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
Sites / Locations
- Center for Infectious Disease Research in Zambia (CIDRZ)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Community level screening; Arm 1
Community level screening: Arm 2
Arm Description
use of chest X-ray plus Xpert Ultra for community level TB screening
use of C-reactive Protein and Xpert Ultra for community level TB screening
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03497195
First Posted
April 6, 2018
Last Updated
September 24, 2019
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03497195
Brief Title
Achieving Tuberculosis (TB) Control In Zambia
Acronym
TB
Official Title
Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community level screening; Arm 1
Arm Type
Active Comparator
Arm Description
use of chest X-ray plus Xpert Ultra for community level TB screening
Arm Title
Community level screening: Arm 2
Arm Type
Active Comparator
Arm Description
use of C-reactive Protein and Xpert Ultra for community level TB screening
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening at community level
Intervention Description
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
Primary Outcome Measure Information:
Title
increase TB case detection
Description
comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monde Muyoyeta, MD,PhD
Organizational Affiliation
Center for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Infectious Disease Research in Zambia (CIDRZ)
City
Lusaka
ZIP/Postal Code
10102
Country
Zambia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33616229
Citation
Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2:CD009593. doi: 10.1002/14651858.CD009593.pub5.
Results Reference
derived
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Achieving Tuberculosis (TB) Control In Zambia
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