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OpenTrials
Completed

NCT Number: NCT03497195

Achieving Tuberculosis (TB) Control In Zambia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, 10102, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening at community level

Diagnostic Test

comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions

Acronym: TB

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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