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

NCT ID: NCT03462615

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 930 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2018-10-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

HS-RDT

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ultra sensitive RDT

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Burnet Institute

OTHER

Sponsor Role: collaborator

Papua New Guinea Institute of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

7815-2/2

Identifier Type: -

Identifier Source: org_study_id