Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women (HSRDT MiP)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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.
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.
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Gender Eligibility Description:
The study will include pregnant women
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.
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
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.