Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women (NCT03172221) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women
Colombia880 participantsStarted 2017-07-25
Plain-language 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.
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy
Timeframe: 1 year
Trial details
NCT IDNCT03172221
SponsorFoundation for Innovative New Diagnostics, Switzerland