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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Diagnostic test: Screening at community level

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 Type: Interventional
• Enrollment (Actual): 18194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia, 10102
    • Center for Infectious Disease Research in Zambia (CIDRZ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Monde Muyoyeta, MD,PhD, Center for Infectious Disease Research in Zambia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: IRB-300001132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No