Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women in Papua New Guinea

NCT03462615 | Unknown

• 1 other identifier: 7815-2/2
• Study Type: observational
• Target: 930
• Locations: 0 countries
• Sites: N/A

Brief Summary

Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth. The Bill \& Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy. The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea

Conditions

Plasmodium Falciparum Malaria; Pregnancy Malaria; Diagnoses Disease

Keywords

malaria; pregnancy; diagnosis; rapid diagnostic test

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  1.1 Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and LAMP in peripheral blood with qPCR as reference test.

  1 year

Interventions

HS-RDT DIAGNOSTIC_TEST

A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.

Also known as: ultra sensitive RDT

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will test samples from pregnant women aged 16 and older, self-presenting at health centres for antenatal care in this malaria-endemic setting

You may qualify if:

• Pregnant women attending first antenatal care visit at selected health facilities
• Resident in the study area for at least 1 year prior to enrolment
• Age ≥ 16
• Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness)
• Willing to provide finger-prick blood sample

You may not qualify if:

• History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record
• Presence of severe malaria as defined by WHO guidelines at the moment of recruitment.
• Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Burnet Institute: collaborator
• Papua New Guinea Institute of Medical Research: collaborator

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Disease

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share