XACT-3

ABOUT US

Headed by Professor Keertan Dheda and funded by the Joint Global Health Trust and the European and Developing Countries Clinical Trials Partnership, the team endeavour to change the landscape of TB diagnostics in developing countries.

OUR MISSION

In this study, the investigators will test the hypothesis that community-based active case finding (ACF) using Gene Xpert Edge housed in a low cost scalable mini-mobile clinic and performed at point-of-care is feasible and more effective than Xpert performed in a centralised laboratory.

What We Aim To Do

AIM 1

To conduct a trial to evaluate multi-country feasibility and impact of an ACF intervention using GeneXpert Edge/OMNI at point-of-care

AIM 2

To bio-phenotype microbiologically confirmed but minimally symptomatic TB patients who are detected as part of an ACF strategy

aim 3

To model cost effectiveness of an ACF strategy using Xpert when located at point-of-care versus distant from point-of-care

primary Outcome measure

The proportion with pre-treatment loss to follow up and/or the proportion of infectious TB patients not initiating treatment within 14 days of diagnosis.

secondary outcome measures

Multiple outcome measures including: time to TB treatment initiation, time-specific proportion of patients initiated on TB treatment up to 60 days, transmission impact using modelling based on exposure scores, imaging and CASS, etc.

health economic outcomes

Cost-effectiveness of an ACF strategy using Xpert Ultra when placed at POC versus distant from point-of-care in terms of cost per TB case diagnosed and/or averted based on transmission modelling, and cost per death and disability-associated life years averted.

XACT PROGRESS

The XACT-3 project has been successfully launched at the South African Site and is well underway for launch at the Zambian, Zimbabwean and Mozambican sites.

members of the community screened

participants enrolled

cases of tb diagnosed

Cass assessments completed