A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV
NCT ID: NCT04043390
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1100 participants
INTERVENTIONAL
2019-01-21
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Start Taking Action For TB Diagnosis
NCT05845112
DIAgnostics for Multidrug Resistant Tuberculosis in Africa
NCT03303963
Multidrug Resistance in Newly Diagnosed TB Patient
NCT06700577
Assessing Diagnostics At Point-of-care for Tuberculosis
NCT05941052
Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)
NCT04988984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CRP and Xpert ULTRA MTB/RIF
Scheme 1 will screen all patients for HIV using rapid tests routinely used by the clinics and a rapid CRP. Patients with CRP \>10 will be further tested using Xpert ULTRA. Individuals with HIV will undergo an HIV VL using Xpert HIV-1 VL.
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.
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).
Culture as reference standard
The investigators will use culture to assess the sensitivity of schemes 1 and 2
CRP and Molbio Truenat MTB
Scheme 2 will screen individuals for HIV and CRP (as in scheme 1) and patients with CRP \>10 will be tested using Molbio Truenat MTB. Individuals with HIV will undergo an HIV VL using Molbio Truenat HIV-VL and individuals with Truenat MTB-positive samples wil be tested with Truenat MTB RIF.
CRP and Molbio Truenat MTB
A molecular assay to detect M tuberculosis DNA Truenat is currently undergoing the process of endorsement by the WHO.
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).
Culture as reference standard
The investigators will use culture to assess the sensitivity of schemes 1 and 2
standard test Xpert
All patients receiving in scheme 1 and scheme 2 will be tested using the standard tests used in the study context. These are rapid HIV tests, Xpert MTB/RIF and culture.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRP and Molbio Truenat MTB
A molecular assay to detect M tuberculosis DNA Truenat is currently undergoing the process of endorsement by the WHO.
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.
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).
Culture as reference standard
The investigators will use culture to assess the sensitivity of schemes 1 and 2
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. At least one of the following criteria: Cough \> 2-week duration, weight loss, unexplained fever, night sweats or haemoptysis.
3. Willing to participate in the study
Exclusion Criteria
2. Known pregnancy
3. Has received or is receiving anti-TB treatment
4. Already diagnosed with TB.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
REACH Ethiopia
UNKNOWN
Bingham University
UNKNOWN
Liverpool School of Tropical Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis E Cuevas, Professor
Role: PRINCIPAL_INVESTIGATOR
Liverpool School of Tropical Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zankli Research Centre
Kobape, Nasarawa State, Nigeria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-063
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.