Achieving Tuberculosis (TB) Control In Zambia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia

NCT05139940

Tuberculosis

COMPLETED

Evaluation of PTB Screening in ANC in Lusaka, Zambia

NCT02053129

Pulmonary Tuberculosis

COMPLETED NA

Alternative Diagnoses in Patients About to Start Empiric Tuberculosis Treatment

NCT06737029

Tuberculosis Lung Diseases

ACTIVE_NOT_RECRUITING

The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa

NCT01990274

Tuberculosis

COMPLETED NA

Effect of Xpert MTB/RIF on Patient Outcomes

NCT02729532

Tuberculosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community level screening; Arm 1

use of chest X-ray plus Xpert Ultra for community level TB screening

Group Type ACTIVE_COMPARATOR

Screening at community level

Intervention Type DIAGNOSTIC_TEST

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

Community level screening: Arm 2

use of C-reactive Protein and Xpert Ultra for community level TB screening

Group Type ACTIVE_COMPARATOR

Screening at community level

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Screening at community level

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes