Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women (HSRDT MiP)

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

This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

Study Overview

• Status: Completed
• Conditions: Diagnoses Disease; Plasmodium Falciparum; Pregnancy Malaria
• Intervention / Treatment: Diagnostic test: HS-RDT

Detailed Description

The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.

• Study Type: Observational
• Enrollment (Actual): 880

Contacts and Locations

• Study Contact: Name: Ana Campillo, PhD; Phone Number: +41 (0) 22 749 19 23; Email: ana.campillo@finddx.org
• Study Contact Backup: Name: Iveth González, PhD; Email: Iveth.Gonzalez@finddx.org

Study Locations

• Colombia
  • Quibdó, Colombia
    • Centro de Salud el Reposo
  • Tumaco, Colombia
    • Hospital Divino Nino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Consecutive pregnant women self-presenting at the selected health care facilities and meeting the eligibility criteria will be invited to participate in the study. After study staff provides full information about the study, pregnant women willing to participate will be asked to sign the informed consent form. They will consent to be interviewed and to provide finger-prick blood. For women younger than 18 years old, additional approval from the parent or legal guardian will be needed if required by local Institutional Review Board (IRB). Participants will be invited to participate at any visit at any trimester.

Description

Inclusion Criteria:

• Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
• Resident for at least 1 year in the study site
• Age ≥ 15
• Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age < 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
• Willingness to provide finger-prick blood sample at enrolment

Exclusion Criteria:

• Past history of malaria and/or antimalarial drugs in the last three months
• Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
• Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
• Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.	1 year

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: Universidad de Antioquia

Publications and helpful links

General Publications

• Vasquez AM, Velez G, Medina A, Serra-Casas E, Campillo A, Gonzalez IJ, Murphy SC, Seilie AM, Ding XC, Tobon Castano A. Evaluation of highly sensitive diagnostic tools for the detection of P. falciparum in pregnant women attending antenatal care visits in Colombia. BMC Pregnancy Childbirth. 2020 Jul 31;20(1):440. doi: 10.1186/s12884-020-03114-4.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Plasmodium falciparum; pregnancy; diagnosis; malaria; rapid diagnostic test; low-transmission
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Disease; Malaria
• Other Study ID Numbers: 7815-2/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No