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

Sponsor

Foundation for Innovative New Diagnostics, Switzerland (Other)

Overall Status

Unknown status

CT.gov ID

NCT03462615

Collaborator

Burnet Institute (Other), Papua New Guinea Institute of Medical Research (Other)

930

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Plasmodium Falciparum Malaria Pregnancy Malaria Diagnoses Disease	Diagnostic Test: HS-RDT

Study Design

Study Type:

Observational

Anticipated Enrollment :

930 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women in Papua New Guinea

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

All women must meet all the following inclusion criteria in order to be eligible to participate in the study:
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

Exclusion Criteria:

Women meeting any of the following exclusion criteria at screening will be excluded from study participation:
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