Xpert Active Case-finding Trial 2: Community-based Active Case-finding for Tuberculosis in South Africa

Summary

TB kills most people with HIV in Africa. TB is out of control. Radically different approaches to deal with the disease is therefor needed. It is known that intensified case finding works in high HIV prevalence environments. However, the poor performance of conventional diagnostics makes the strategy costly and unpalatable for policy makers. If it can be shown that a package of new diagnostic technologies significantly enhances ease and speed of diagnosis, and time to treatment initiation when using intensified case finding, this will usher the way for further studies and policy adjustments to tackle TB. Thus, the work, if found to be useful, could have major policy implications

The purpose of this study will be to determine the diagnostic yield, impact and feasibility of community-based intensified TB case finding using symptom screening, point-of-care TB testing (Xpert Omni), point-of-care HIV testing and CD4 count (Alere PIMA), if HIV-infected, together with a clinic-based diagnostic package (sputum smear microscopy, MGIT sputum culture, and digital chest radiograph). Additionally, the study will assess the infectiousness of previously undiagnosed TB cases in the community using cough aerosol sampling technology (CASS) and will determine the genomic, transcriptomic and lipidomic profile of TB isolates from patients undergoing CASS sampling. The cost-effectiveness of using a novel TB diagnostic platform (Xpert Omni) for intensified case finding compared to conventional methods will also be evaluated.

\~6000 people will be screened to enrol 600 participants with suspected TB. It is expected that using the GeneXpert® Omni POC mobile clinic of 2- to 3-person team of healthcare workers in an inexpensive panel van will substantially reduce the time to treatment initiation, and the proportion of individuals initiating and completing TB treatment. Investigators will also review and follow up Household contacts of active TB participants.

As part of the study investigators will also contribute data and specimens to the RePORT consortium (Regional Prospective Observational Research for Tuberculosis), that aims to create a multinational bank with the primary objective of providing specimens and data to RePORT consortia biomarker researchers and their collaborators over the next decade to achieve a better understanding of the prognosis of TB disease; and the pathogenesis of progression from TB exposure to disease.

Conditions

• Tuberculosis

Interventions

OTHER

GeneXpert MTB/RIF

Screening intervention: novel diagnostic for active case finding (GeneXpert MTB/RIF) for TB collected and performed at point-of-contact in a mobile van

OTHER

Smear microscopy

Screening intervention: routine diagnostic test (smear microscopy) for active case finding for TB on sputum collected at point-of-contact in a mobile van but sent to laboratory

Sponsors & Collaborators

• Medical Research Council, South Africa

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• University of Cape Town Lung Institute

  collaborator OTHER

• University of Cape Town

  lead OTHER

Principal Investigators

• Keertan Dheda, MBChB, PhD · Head of Lung Infection and Immunity Unit and Division and Pulmonology

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2020-06-30

Completion

2020-08-31

Countries

• South Africa

Study Locations