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

Summary

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.

Conditions

• Tuberculosis
• Hiv

Interventions

DIAGNOSTIC_TEST

CRP and Molbio Truenat MTB

A molecular assay to detect M tuberculosis DNA Truenat is currently undergoing the process of endorsement by the WHO.

DIAGNOSTIC_TEST

CRP and Xpert ULTRA MTB/RIF

A molecular assay to detect M tuberculosis DNA ULTRA is already endorsed by the WHO. However the tests are still considered experimental in Nigeria and Ethiopia.

DIAGNOSTIC_TEST

standard test Xpert

The investigators will use Xpert to compare its agreement with scheme 1 (CRP plus Truenat MTB) and scheme 2 (CRP plus ULTRA).

DIAGNOSTIC_TEST

Culture as reference standard

The investigators will use culture to assess the sensitivity of schemes 1 and 2

Sponsors & Collaborators

• REACH Ethiopia

  collaborator UNKNOWN

• Bingham University

  collaborator UNKNOWN

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Luis E Cuevas, Professor · Liverpool School of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-21

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Nigeria