Achieving Tuberculosis (TB) Control In Zambia
TB
Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
1 other identifier
interventional
18,194
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedSeptember 25, 2019
September 1, 2019
1.5 years
April 6, 2018
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Community level screening; Arm 1
ACTIVE COMPARATORuse of chest X-ray plus Xpert Ultra for community level TB screening
Community level screening: Arm 2
ACTIVE COMPARATORuse of C-reactive Protein and Xpert Ultra for community level TB screening
Interventions
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
Eligibility Criteria
You may qualify if:
- Program Implementation:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, 10102, Zambia
Related Publications (1)
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(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
PMID: 33616229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monde Muyoyeta, MD,PhD
Center for Infectious Disease Research in Zambia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
April 6, 2018
First Posted
April 13, 2018
Study Start
July 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
September 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share