Achieving Tuberculosis (TB) Control In Zambia

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT03497195

Collaborator

(none)

18,194

Enrollment

Location

Arms

Actual Duration (Months)

1010.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Diagnostic Test: Screening at community level	N/A

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

Study Type:

Interventional

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 :

Jul 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Primary Outcome Measures

increase TB case detection [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Center for Infectious Disease Research in Zambia (CIDRZ)	Lusaka		Zambia	10102

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Monde Muyoyeta, MD,PhD, Center for Infectious Disease Research in Zambia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stewart Reid, Primary Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03497195

Other Study ID Numbers:

IRB-300001132

First Posted:

Apr 13, 2018

Last Update Posted:

Sep 25, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tuberculosis

Study Results

No Results Posted as of Sep 25, 2019