Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000426482
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical validation and value proposition of Next Generation Malaria Rapid Diagnostic Test in Lao People's Democratic Republic
Scientific title
Clinical validation and value proposition of Next Generation Malaria Rapid Diagnostic Test (RDT) among individuals suspected of having malaria in Lao People's Democratic Republic (PDR): a diagnostic accuracy study with nested mixed methods
Secondary ID [1] 314207 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 337103 0
Condition category
Condition code
Infection 333523 333523 0 0
Other infectious diseases
Public Health 333524 333524 0 0
Health service research
Public Health 333532 333532 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: a new "Next Generation" rapid diagnostic test (RDT) with a combined HRP2 and LDH line (SD Biosensor P. f/P. v Combo RDT).

Brief Name: NextGen RDT.

WHY: To assess diagnostic accuracy of NextGen RDTs in malaria case detection.

WHAT Materials:
- NextGen RDT usage instructions and information materials, in Lao language
- informed consent form for people requiring malaria testing
- malaria testing and treatment form (N1 form)
- filter paper for dried blood spots
- SD Biosensor P. f/P. v Combo RDT kit, including the test device, buffer, sterile lancet, and alcohol swab.
- zip lock bag and desiccant for shipment of dried blood spots
- unique identifier stickers

WHAT Procedures:
The Community Health Workers (CHWs) who are providing malaria services in the study area will be invited to use the NextGen RDTs in their malaria testing or screening activities, including active, passive and reactive case detections in the community setting. Community members who are identified for malaria testing in routine practice will be invited into the study to be tested by the NextGen RDT, in addition to the current standard (conventional) RDT, and to also have dried blood spots (DBS) collected for polymerase chain reaction (PCR) testing, the reference (gold standard) for detecting malaria parasites. CHWs will provide information on the study and seek informed consent prior to any testing. If the person agrees to participate, they will be enrolled in the study.

After receiving consent from the person to be tested, CHWs will perform malaria testing using the NextGen RDTs and current standard RDT; the RDT results will be read within 15 minutes and recorded at the point of care. the whole process of RDTs testing will take approximately 30 minutes. CHWs will also take two or three drops of whole blood on the filter paper to get the DBS. The blood for both RDTs and the DBS will be taken from the same finger prick, using a single lancet (supplied in the RDT kits). Participant information will be recorded on an ‘N1’ form, including the results of the RDTs and any treatments given. The standard case report form (F1 form) will also be filled in for positive cases as per routine practice. A photo of the RDTs will be taken for quality control purposes. The DBSs will be put in a zip lock bag for shipment to Laos Centre of Malariology, Parasitology and Entomology’s (CMPE) laboratory in Vientiane. The RDTs, DBS, N1 form, and zip lock bag will be deidentified by putting code stickers with unique identifiers. Individuals with a positive result by routine standard RDT will be treated for malaria as per the National Malaria Treatment Guidelines. If the NextGen RDT is positive when the standard RDT is negative (for either species), the CHW will refer the case to the microscopy centre for confirmation; if this is not feasible, the individual will be treated for the NextGen RDT positive result as per the National Malaria Treatment Guidelines.

The DBS will be stored and shipped at the end of each month to the CMPE’s laboratory in Vientiane where the PCR is available per standard operating procedures. The DBS will be tested with PCR for malaria parasites species, their density in blood and hrp2/3 deletions in P. falciparum confirmed infections suspected of hrp2/3 deletion (NextGen RDT positive and standard RDT negative for P.f) and as a result of false negative currently used RDT test results in samples with strong PCR signal (low Ct values).

WHO Provided:
The intervention is being provided by CHWs. CHWs in Lao PDR are trained to perform malaria diagnosis using RDTs and to provide malaria treatment as per the National Malaria Treatment Guidelines if RDT result is positive. Within this study, CHWs will get training of eight hours on the operation of NextGen RDTs, collecting dried blood spot (DBS), data and sample storage, and shipment at least two weeks prior to the start of the intervention. Usage instruction and information materials of NextGen RDT will be translated into Laos and the training will be delivered in local language by national trainers (Health Poverty Action (HPA) [Laos] staff).

HOW & WHERE: NextGen RDTs will be delivered via normal malaria testing and screening activities, within the CHW program. This will include:
• Passive case detection: occurring at the CHWs place of work (usually their home)
• Active case detection: occurring in the field, e.g. screening at check points.
• Reactive case detection: occurring after detecting an index malaria case in the area

WHEN AND HOW MUCH: The NextGen RDT will be used only once, for each suspected malaria episode. Participants can be enrolled more than once across different episodes.

TAILORING: None.

HOW WELL: If the CHW has access to a smart phone, they will be instructed to take a picture of the RDTs labelled with unique identifier stickers for quality assurance purposes (i.e. to check that a valid result has been produced, and that it has been interpreted correctly).
Intervention code [1] 330810 0
Diagnosis / Prognosis
Comparator / control treatment
No control group (diagnostic accuracy study)
Gold standard test: Polymerase chain reaction (PCR) is used as the reference comparator for NextGen RDT and standard malaria RDT for the detection of Plasmodium spp. infection.

Both the intervention test (NextGen RDT) and the current standard malaria RDT will be evaluated for accuracy against PCR.
Control group
Active

Outcomes
Primary outcome [1] 341100 0
NextGen RDT sensitivity
Timepoint [1] 341100 0
At the time of malaria testing (diagnostic study).
Primary outcome [2] 341121 0
NextGen RDT specificity
Timepoint [2] 341121 0
At the time of malaria testing (diagnostic study).
Secondary outcome [1] 446229 0
NextGen RDT negative predictive value (NPV).
Timepoint [1] 446229 0
At the time of malaria testing (diagnostic study).
Secondary outcome [2] 446230 0
Current RDT diagnostic accuracy.
Timepoint [2] 446230 0
At the time of malaria testing (diagnostic study).
Secondary outcome [3] 446354 0
Ability of the NextGen RDT to enhance identification of Plasmodium spp. infections.
Timepoint [3] 446354 0
At the time of malaria testing (diagnostic study).
Secondary outcome [4] 446355 0
Total implementation cost (US$) of switching to NextGen RDTs (start-up costs).
Timepoint [4] 446355 0
Over the duration of the intervention period.
Secondary outcome [5] 446356 0
Themes regarding the acceptability of the NextGen RDTs to the CHWs providing malaria diagnostic services in Lao PDR
Timepoint [5] 446356 0
At the time of the focus group discussion and in-depth interviews, conducted within 3 months of the end of the intervention (last test).
Secondary outcome [6] 446357 0
Themes regarding feasibility to deploy the NextGen RDTs in different case-finding strategies in Lao PDR from the perspective of malaria program staff who oversee and design malaria control and elimination activities in Lao PDR.
Timepoint [6] 446357 0
At the time of the interviews, administered within 3 months of the end of the intervention (last test).
Secondary outcome [7] 446358 0
Proportion of the CHWs who can comprehend the usage instruction (in Laotian) labelled on the package of NextGen RDTs and accurately interpret the results
Timepoint [7] 446358 0
At the time of the survey, administered within 3 months of the end of the intervention (last test).
Secondary outcome [8] 446359 0
Percentage of P. falciparum cases detected by PCR with HRP2/3 deletion
Timepoint [8] 446359 0
At the time of malaria testing (diagnostic study).
Secondary outcome [9] 446360 0
Percentage breakdown by Plasmodium species, amongst cases diagnosed by PCR, NextGen RDT (excluding false positives) and current standard RDT (excluding false positives).
Timepoint [9] 446360 0
At the time of malaria testing (diagnostic study).
Secondary outcome [10] 447022 0
NextGen RDT positive predictive value (PPV).
Timepoint [10] 447022 0
At the time of malaria testing (diagnostic study).
Secondary outcome [11] 447023 0
Incremental cost-effectiveness ratio (ICER) representing the difference in cost per additional case detected
Timepoint [11] 447023 0
Over the duration of the intervention period.

Eligibility
Key inclusion criteria
Community members to be tested for malaria
o Individuals who live in the study villages or seek health services from community health workers (CHWs) (active, passive or reactive case detections). They may have signs and symptoms of malaria or be healthy individuals who carry parasite.

CHWs for focus group discussion and survey
o The workers must provide malaria services in the study area.

Malaria program stakeholder for in-depth interview
o The malaria program stakeholders must be stakeholders responsible for designing and overseeing the malaria control and elimination activities focusing diagnosis.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
CHWs who are not assigned in the study area

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sensitivity, specificity, positive and negative predictive values of NextGen RDT will be estimated with exact binomial 95% CI. Endpoints relating to the epidemiology of Plasmodium spp. and CHW comprehension and interpretation will be analysed descriptively (frequency and percentage). Further detail statistical analysis plan will be developed prior to data analysis.

The lower bound of the exact 95% confidence interval for an estimated sensitivity of 90% was calculated, assuming a total of 36,000 tests with current RDT will be conducted in the study area over 12 months across all testing strategies, a PCR test-positivity of 0.5%, a drop-out rate of 67% assuming only 33% (n=12,000) consent amongst the tested population (36,000) for testing with NextGen RDT and provide DBS for PCR testing, and a design effect of 2 to account for clustering. PCR test-positivity of 0.5% was based on RDT positivity rates in 2023-2024 within the study area (0.63% and declining), and RDT and PCR positivity rates in the Laos sites of the previous trial (0.46% and 1.84%, respectively). Based on these assumptions, 54 PCR-positive cases will be detected during the study amongst consenting participants, and the lower bound of the exact 95% confidence interval for an estimated sensitivity of 90% will be around 70% after accounting for clustering.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
12000
Accrual to date
Final
Recruitment outside Australia
Country [1] 26977 0
Lao People's Democratic Republic
State/province [1] 26977 0
Attapu, Champasak, Khammouan, Savannakhet, Salavan and Xekong,

Funding & Sponsors
Funding source category [1] 318723 0
Government body
Name [1] 318723 0
The Department of Foreign Affairs and Trade
Country [1] 318723 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
PATH
Address
Country
United States of America
Secondary sponsor category [1] 321159 0
Charities/Societies/Foundations
Name [1] 321159 0
Burnet Institute
Address [1] 321159 0
Country [1] 321159 0
Australia
Other collaborator category [1] 283472 0
Government body
Name [1] 283472 0
Centre of Malariology, Parasitology and Entomology
Address [1] 283472 0
Country [1] 283472 0
Lao People's Democratic Republic
Other collaborator category [2] 283473 0
Charities/Societies/Foundations
Name [2] 283473 0
Health Poverty Action Laos
Address [2] 283473 0
Country [2] 283473 0
Lao People's Democratic Republic
Other collaborator category [3] 283474 0
Charities/Societies/Foundations
Name [3] 283474 0
Community Health and Inclusion Association
Address [3] 283474 0
Country [3] 283474 0
Lao People's Democratic Republic
Other collaborator category [4] 283475 0
Charities/Societies/Foundations
Name [4] 283475 0
Population Education and Development Association
Address [4] 283475 0
Country [4] 283475 0
Lao People's Democratic Republic
Other collaborator category [5] 283476 0
University
Name [5] 283476 0
University of Melbourne
Address [5] 283476 0
Country [5] 283476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317335 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317335 0
Ethics committee country [1] 317335 0
Australia
Date submitted for ethics approval [1] 317335 0
17/02/2025
Approval date [1] 317335 0
28/03/2025
Ethics approval number [1] 317335 0
114649 (Local Reference: Project 27/25)
Ethics committee name [2] 317339 0
National Ethic Committee for Health Research
Ethics committee address [2] 317339 0
Ethics committee country [2] 317339 0
Lao People's Democratic Republic
Date submitted for ethics approval [2] 317339 0
02/04/2025
Approval date [2] 317339 0
Ethics approval number [2] 317339 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140722 0
Dr Win Han Oo
Address 140722 0
Level 3, Building 379, 207 Bouverie Street, University of Melbourne, Victoria 3010
Country 140722 0
Australia
Phone 140722 0
+61390355446
Fax 140722 0
Email 140722 0
[email protected]
Contact person for public queries
Name 140723 0
Win Han Oo
Address 140723 0
Level 3, Building 379, 207 Bouverie Street, University of Melbourne, Victoria 3010
Country 140723 0
Australia
Phone 140723 0
+61390355446
Fax 140723 0
Email 140723 0
[email protected]
Contact person for scientific queries
Name 140724 0
Win Han Oo
Address 140724 0
Level 3, Building 379, 207 Bouverie Street, University of Melbourne, Victoria 3010
Country 140724 0
Australia
Phone 140724 0
+61390355446
Fax 140724 0
Email 140724 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24642Ethical approval    27-25 Ethics Approval 28-Mar-2025.pdf



Results publications and other study-related documents

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