Clinical trial NCT03172221: Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women
Official title: Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Falciparum
Pregnancy Malaria
Diagnoses Disease
Keywords: malaria
pregnancy
diagnosis
low-transmission
Plasmodium falciparum
rapid diagnostic test
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Universidad de Antioquia
First posted: 2017-06-01
Enrollment: 880
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Quibdó
country: Colombia
facility: Centro de Salud el Reposo
city: Tumaco
country: Colombia
facility: Hospital Divino Nino
Study officials:
References:
citation: 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.