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Achieving Tuberculosis (TB) Control In Zambia (TB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497195
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Stewart Reid, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tuberculosis Diagnostic Test: Screening at community level Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18194 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Community level screening; Arm 1
use of chest X-ray plus Xpert Ultra for community level TB screening
 Diagnostic Test: Screening at community level
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
Active Comparator: Community level screening: Arm 2
use of C-reactive Protein and Xpert Ultra for community level TB screening
 Diagnostic Test: Screening at community level
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening


Outcome Measures
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Primary Outcome Measures :
  1. increase TB case detection [ Time Frame: 6 months ]
    comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497195


Locations
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Zambia
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia, 10102
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Monde Muyoyeta, MD,PhD Center for Infectious Disease Research in Zambia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stewart Reid, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03497195    
Other Study ID Numbers: IRB-300001132
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections