Evaluating a novel diagnostic test for the detection of Plasmodium infections at community level in The Gambia and Burkina Faso

ISRCTN	ISRCTN15263932
DOI	https://doi.org/10.1186/ISRCTN15263932
Secondary identifying numbers	29611

Submission date: 18/07/2024
Registration date: 15/08/2024
Last edited: 15/08/2024

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
To advance the goal of malaria elimination, targeting the entire human malaria reservoir, encompassing both symptomatic and asymptomatic infections is imperative. Active detection interventions, involving community-level testing and treatment approaches, could contribute to achieving this objective. A key prerequisite for the success of such interventions is the availability of highly sensitive and field-deployable diagnostic tests capable of detecting all infections, including those of low parasite density in asymptomatic carriers. Conventional diagnostic tests such as Rapid Diagnostic Tests (RDT), microscopy, and Polymerase Chain Reaction (PCR) currently fall short of meeting these criteria. A novel molecular-based test, Dragonfly, exhibit the potential to address the challenge of detecting low parasite-density infections. The study aims to evaluate the diagnostic accuracy of Dragonfly in detecting Plasmodium infection at community level.

Who can participate?
Individuals aged 6 months and above residing in the two study sites

What does the study involve?
Once consent has been obtained, a questionnaire will be introduced to each participant to collect socio-demographic data such as age, sex; preventive measures against malaria that the person is using; symptoms presented by the participant at the time of the interview. A few drops of blood will then be taken from the participant's finger to perform the malaria tests.

What are the possible benefits and risks of participating?
As a direct benefit, all participants will receive malaria screening using RDTs validated by the National Malaria Control Program. Those who test positive will be treated according to the National Malaria Control Program guidelines. Moreover, it is hoped that the information gained from this study will be used to guide the fight against malaria in the two countries and beyond. There is minimal risk associated with the collection of a blood specimen. The participant may experience pain, discomfort when pricked on the finger. Samples will be taken by trained health professionals using sterile and single-use equipment.

Where is the study run from?
MRC Unit The Gambia at LSHTM, Banjul Fajara (The Gambia)
Clinical Research Unit of Nanoro, Nanoro Department (Burkina Faso)

When is the study starting and how long is it expected to run for?
June 2022 to June 2026

Who is funding the study?
The study is funded by the NIHR (NIHR-Global Health Research Group's Digital Diagnostics for African Health Systems, project reference NIHR134694) using UK International Development funding from the UK Government to support global health research. The views expressed are those of the authors and not necessarily those of the NIHR or the UK government.

Who is the main contact?
Dr Dimbintsoa Rakotomalala Robinson, Dimbintsoa.Rakotomalal1@lshtm.ac.uk

Contact information

Prof Umberto D' Alessandro
Scientific, Principal Investigator

MRC Unit The Gambia at LSHTM, Atlantic Boulevard Road, Fajara
Banjul
PO Box 273
Gambia

ORCID ID	0000-0001-6341-5009
Phone	+220 449 5442
Email	umberto.dalessandro@lshtm.ac.uk

Prof Halidou Tinto
Principal Investigator

Clinical Research Unit Nanoro
Nanoro
-
Burkina Faso

ORCID ID	0000-0002-0472-3586
Phone	+226 703 463 54
Email	halidoutinto@gmail.com

Dr Annette Erhart
Public, Scientific

MRC Unit The Gambia at LSHTM, Atlantic Boulevard Road, Fajara
Banjul
PO Box 273
Gambia

ORCID ID	0000-0002-0522-4965
Phone	+220 700 9779
Email	annette.erhart@lshtm.ac.uk

Dr Dimbintsoa Rakotomalala Robinson
Public, Scientific

MRC Unit The Gambia at LSHTM, Atlantic Boulevard Road, Fajara
Banjul
PO Box 273
Gambia

ORCID ID	0009-0001-9772-3533
Phone	+220 72 059 38
Email	Dimbintsoa.Rakotomalala1@lshtm.ac.uk

Study information

Study design	Multicenter cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Community
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Evaluating a novel diagnostic test for the detection of Plasmodium infections at community level in The Gambia and Burkina Faso
Study acronym	DIDA-SP1
Study hypothesis	The novel diagnostic test, Dragonfly, a novel LAMP-based technology, can accurately detect Plasmodium infections, including asymptomatic carriers characterized by low parasite densities
Ethics approval(s)	1. Approved 17/11/2023, London School of Hygiene and Tropical Medicine Ethics Committee (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)20 7636 8636; ethics@lshtm.ac.uk), ref: 29611‑ 1 2. Approved 06/11/2023, The Gambia Government/MRC Joint Ethics Committee (MRC unit The Gambia at LSHTM, Banjul, 273, Gambia; +220 4495919; ethics@mrc.gm), ref: 29611 3. Approved 06/03/2024, Comite d'Ethique pour la Recherche en Sante- Ministere de la Sante et de l'Hygiene Publique Burkina Faso (Ministère de la Santé Building Lamizana, Ouagadougou, -, Burkina Faso; -; noEmail@ddressProvided), ref: 2024-03-61
Condition	Diagnosis of Plasmodium infection
Intervention	Clinical samples will be obtained from participants recruited through community-based cross-sectional surveys. These samples will be tested for Plasmodium infection using Dragonfly, RDT, microscopy, and PCR. The diagnostic performance of the novel test will be assessed by comparing its results with those obtained from PCR.
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dragonfly
Primary outcome measure	Diagnostic accuracy of Dragonfly in detecting Plasmodium infection at the time of recruitment assessed by comparing Dragonfly results against reference standard (PCR).
Secondary outcome measures	1. Diagnostic accuracy of RDT in detecting Plasmodium infection at the time of recruitment by comparing RDT results against reference standard (PCR). 2. Diagnostic accuracy of microscopy in detecting Plasmodium infection at the time of recruitment by comparing microscopy results against reference standard (PCR). 3. Ease of use of Dragonfly assessed using qualitative interview guides within 4 weeks after presentation of Dragonfly technology to the potential users. 4. Factors influencing the uptake of community-based interventions such as mass testing and treatment assessed using qualitative interview guides within 6 months after the cross-sectional surveys.
Overall study start date	01/06/2022
Overall study end date	20/06/2026

Eligibility

Participant type(s)	Population
Age group	All
Lower age limit	6 Months
Sex	Both
Target number of participants	1900
Participant inclusion criteria	1. >6 months of age 2. Present in the household at the time of the interviews 3. Consent to participate in the study (or consent given by an adult caregiver if <18 years old and assent for children ≥12 years old)
Participant exclusion criteria	Does not meet inclusion criteria
Recruitment start date	09/11/2023
Recruitment end date	31/12/2025

Locations

Countries of recruitment

Burkina Faso
Gambia

Study participating centres

MRC Unit The Gambia at LSHTM

Atlantic Boulevard, Fajara
Banjul
PO Box 273
Burkina Faso

Clinical Research Unit Nanoro

Clinical Research Unit Nanoro
Nanoro Department
-
Burkina Faso

Sponsor information

MRC Unit The Gambia at LSHTM
Research council

Atlantic Boulevard Road, Fajara
Banjul
PO Box 273
Gambia

Phone	+220 4495835 / 4495443-6
Email	information@mrc.gm
Website	https://www.lshtm.ac.uk/research/units/mrc-gambia

Clinical Research Unit Nanoro
Research organisation

Nanoro
Nanoro Department
-
Burkina Faso

Phone	+226 25409212
Email	info@crun.bf
Website	https://crun.bf/

Funders

Funder type

Government

NIHR Global Health Research Group on Digital Diagnostics for Africa

No information available

Results and Publications

Intention to publish date	20/06/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Prof. Umberto D'Alessandro (umberto.dalessandro@lshtm.ac.uk)

Editorial Notes

18/07/2024: Trial's existence confirmed by London School of Hygiene and Tropical Medicine Ethics Committee.