Skip to main content
OpenTrials
Completed

NCT Number: NCT04043390

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zankli Research Centre

Kobape, Nasarawa State, P.M.B 005, Nigeria

About this study

The study will enrol patients in TB clinics based in 4 selected district hospitals (two in Nigeria and two in Ethiopia) and samples will be processed in a single reference laboratory. This diagnostic evaluation trial will comprise two experimental diagnostic schemes which will be compared against the standard of care:

  • One experimental arm (scheme 1) will screen all patients for HIV using two rapid tests routinely used by the clinics and a rapid CRP. Selected patients will be further tested using ULTRA. Individuals with HIV will undergo an HIV VL using Xpert.
  • A second experimental arm (scheme 2): will screen individuals for HIV and CRP (as in scheme 1) and selected patients will be tested using Molbio Truenat MTB. Individuals with HIV will undergo an HIV VL using Molbio Truenat HIV-VL and Truenat RIF.
  • In addition, all patients will be tested using the standard of care consistent of confirmatory HIV and CRP tests, Xpert MTB/RIF and culture.
  • Randomisation All patients will be randomised at a ratio of 1:1 into schemes 1 and 2. Random numbers will be generated in LSTM by a statistician independent to the study. The scheme allocations will be included in study envelopes assigned to individual study numbers. Equal number of participants will be included in Nigeria and Ethiopia.
  • Proposed methods for protecting against source bias

As this is an open trial, the classification of patients will be based on objective quantitative results of laboratory tests. It is expected the test performances will vary according to HIV status. Participants will be classified according to their experimental test results

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult with presumptive TB
  • At least one of the following criteria: Cough > 2-week duration, weight loss, unexplained fever, night sweats or haemoptysis.
  • Willing to participate in the study

Exclusion criteria

  • Age unknown and likely being a minor (looks <18 years old)
  • Known pregnancy
  • Has received or is receiving anti-TB treatment
  • Already diagnosed with TB.

Treatment and study plan

CRP and Molbio Truenat MTB

Diagnostic Test

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

Other names: CRP and Truelab MTB

CRP and Xpert ULTRA MTB/RIF

Diagnostic Test

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.

Other names: CRP and ULTRA

standard test Xpert

Diagnostic Test

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

Culture as reference standard

Diagnostic Test

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

Primary outcomes

  1. Performance of two diagnostic schemes for the diagnosis of TB when compared to culture.

    Time frame: "up to two months", once culture results become available

    Sensitivity, specificity, positive and negative predictive values of schemes 1 and 2 to identify patients with TB. Culture will used as the reference standard.

Secondary outcomes

  1. Agreement of two diagnostic schemes for the diagnosis of TB when compared to Xpert.

    Time frame: "up to two months", once culture results become available

    Assessment of the agreement between the results obtained with schemes 1 and 2 and Xpert MTB/RIF.

    Xpert MTB/RIF is the recommended test for diagnosis and patients are managed according to their Xpert MTB/RIF results and clinical assessment. The investigators will describe whether the use of the schemes would result in a similar yield than the yield obtained by Xpert.

  2. Time required for diagnosis of the two diagnostic schemes compared to Xpert.

    Time frame: 10 months

    The investigators will describe the time required to achieve a diagnosis.

  3. Cost required for diagnosis of the two diagnostic schemes compared to Xpert.

    Time frame: 10 months

    The investigators will describe the costs of the tests in schemes 1 and 2 and compare these costs with the costs of screening all patients with Xpert MTB/RIF.

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Bingham University
  • REACH Ethiopia

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.