NCT04043390

A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV

Completed NA Last updated 2 August 2021

What this trial tests

NA trial testing CRP and Molbio Truenat MTB in Tuberculosis in 1,100 participants. Completed in 31 December 2020.

Timeline

21 January 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Liverpool School of Tropical Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	1,100
Start date	21 January 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Nigeria

Drugs / interventions tested

• CRP and Molbio Truenat MTB
• CRP and Xpert ULTRA MTB/RIF
• standard test Xpert
• Culture as reference standard

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Hiv — all drugs for Hiv →

Sponsor

Liverpool School of Tropical Medicine

Who can join

18 and older, any sex, with Tuberculosis or Hiv. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TB is a major public health problem and the second most common cause of adult death due to infection in many low-income countries. Despite major efforts to de-centralise services, accessibility to diagnosis is still limited, with one third of the 9 million cases occurring each year being missed by national control programmes.

New TB diagnostics suitable for use at the point-of-care are emerging. Some of these are intended for screening purposes, as an initial step to identify individuals who may have TB and should undergo further tests for confirmation. These tests may have high sensitivity, but also give false-positive results (low specificity). Other tests aim to be the confirmatory tests for TB (high specificity), but these tests are often more expensive and complex and are only available in hospital laboratories. As these tests have different purposes, it is likely they would work better in combination in a step fashion to optimise their impact and to develop an efficient diagnostic process. Furthermore, as none of the tests is versatile enough to be used in all settings, test combinations will need to consider the health system context in which they would be used. Our aim is to develop and evaluate rapid and accurate diagnostic approaches for TB that facilitate the initiation of appropriate treatment on the same day of the initial consultation in Africa.

The objectives are to

1. Evaluate new diagnostics for TB (including among HIV co-infected individuals) that are suitable at the point-of-care;
2. Develop diagnostic algorithms that streamline and accelerate the diagnosis of TB, allowing patients to reach clinical management decisions within a single clinic visit;
3. Determine the impact of using novel point-of-care diagnostic combinations on the proportion of patients correctly initiating TB treatment within 24-48 hours of first attendance; their potential cost effectiveness

The investigators conducted studies in 2016-2018 to accomplish the first two objectives and have identified diagnostic tests that are suitable for low and middle income countries.

This document therefore refers to objective 3, which aims to

1. Assess the performance of two diagnostic schemes for the diagnosis of TB when compared to culture.
2. Assess the yield of two diagnostic schemes for the diagnosis of TB when compared to Xpert and
3. Assess the cost of the two diagnostic schemes compared to Xpert.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents.
   Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, et al · · 2025 · cited 5× · PMID 40122135 · DOI 10.1002/14651858.cd015543.pub2