Clinical trial NCT05514886: Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings
Official title: Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: University of Kinshasa, The Democratic Republic of Congo
name: Research Institute for Health Sciences - Burkina Faso
name: Universiteit Antwerpen, Belgium
name: Københavns Universitet
name: Universidad de Valencia, Spain
First posted: 2022-08-25
Enrollment: 3429
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection

Brief summary: This study evaluated the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.

Detailed description: Project Title: Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (RIA2020EF-2990) - EXPERT-CoV-2

Clinical Trial Registration: NCT05514886

Principal Investigator: Dr Daniel T. R Minja, NIMR- Tanga Centre, Korogwe Research Station, Tanzania

Collaborating Partners: University of Kinshasa, DR Congo, Research Institute for Health Sciences, Burkina Faso, University of Copenhagen, Denmark, University of Antwerp, Belgium, University of Valencia, Spain

Funding: This project (RIA2020EF-2990) is part of the EDCTP2 programme supported by the European Union.

Date: 17th July 2024

Background: Rapid diagnostic tests of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implementing early case detection and management to control the spread of the deadly virus. RT-PCR is the gold standard for the detection of SARS-CoV-2 but its availability and usability is impeded by fragmented laboratory infrastructure in LMICs and even when available it's only found in reference labs.

The recent development of the Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test, Cepheid Sunnyvale, CA) for SARS-CoV-2 testing in the clinics with results delivery within hours of sample collection has been vital in resolving the turnaround time (TAT). GeneXpert has been widely rolled out within national tuberculosis (TB) and HIV programmes across Africa. However, evaluation of its diagnostic accuracy and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.

Study objective: This study is envisaged to evaluate the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.

Methods and Results: This study was conducted in Tanzania, Burkina Faso and DR Congo between 21st July 2021 and February 2024. Data analyses are ongoing and further updates will be made available once the final phylogenetic analyses are completed and ready for publication, details of the clades and variants will also be available.

Eligibility criteria: Inclusion Criteria:

* Aged 5 years and above presenting with symptoms as indicated in national COVID-19 standard cases definitions or
* Presence of one or more respiratory symptoms (fever (defined as \>37.5°C), Persistent coughs, headache, myalgia, sore throat ) or One risk factor for COVID-19, including known contact with a patient with COVID-19, underlying comorbidities, smoking.
* Provision of an informed consent/assent (for minors aged 11-17 years) by themselves or parents/guardians to participate

Exclusion Criteria:

* Inability or unwillingness to give written informed consent/assent.

Primary outcomes:
measure: Proportion of patients with SARS-CoV-2 infection
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanga
country: Tanzania
facility: Nimr Korogwe
Study officials:
affiliation: National Institute for Medical Research, Tanzania
name: DANIEL TR MINJA, PhD
role: PRINCIPAL_INVESTIGATOR
References: