A total of 664 HIV-infected pregnant women will be enrolled to evaluate the safety and efficacy of monthly dihydroartemisinin-piperaquine compared to placebo.
Monthly courses of dihydroartemisinin-piperaquine could reduce the proportion of malaria infections at delivery compared to standard care.
The primary outcome is the prevalence of maternal malaria infection at the time of delivery.
Secondary outcomes include the rates of malaria-related complications for both mothers and infants.
Participants will be monitored for adverse perinatal outcomes and mother-to-child transmission of HIV.
The trial is designed to ensure a comprehensive evaluation of the treatment's impact across various factors such as location and season.
Simplified
INTRODUCTION: Malaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. (IPTp) with sulphadoxine-pyrimethamine is recommended for malaria prevention in HIV-uninfected women, but it is contraindicated in those HIV-infected on (CTXp) due to potential adverse effects. Dihydroartemisinin-piperaquine (DHA-PPQ) has been shown to improve antimalarial protection, constituting a promising IPTp candidate. This trial's objective is to determine if monthly 3-day IPTp courses of DHA-PPQ added to daily CTXp are safe and superior to CTXp alone in decreasing the proportion of peripheral malaria parasitaemia at the end of pregnancy.
METHODS AND ANALYSIS: This is a multicentre, two-arm, placebo-controlled, individually randomised trial in HIV-infected pregnant women receiving CTXp and antiretroviral treatment. A total of 664 women will be enrolled at the first antenatal care clinic visit in sites from Gabon and Mozambique. Participants will receive an insecticide-treated net, and they will be administered monthly IPTp with DHA-PPQ or placebo (1:1 ratio) as directly observed therapy from the second trimester of pregnancy. Primary study outcome is the prevalence of maternal parasitaemia at delivery. Secondary outcomes include prevalence of malaria-related maternal and infant outcomes and proportion of adverse perinatal outcomes. Participants will be followed until 6 weeks after the end of pregnancy and their infants until 1 year of age to also evaluate the impact of DHA-PPQ on mother-to-child transmission of HIV. The analysis will be done in the intention to treat and according to protocol cohorts, adjusted by gravidity, country, seasonality and other variables associated with malaria.
ETHICS AND DISSEMINATION: The protocol was reviewed and approved by the institutional and national ethics committees of Gabon and Mozambique and the Hospital Clinic of Barcelona. Project results will be presented to all stakeholders and published in open-access journals.
TRIAL REGISTRATION NUMBER: NCT03671109.
Key numbers
664
Target Enrollment
Total number of women planned for recruitment across two countries.
2
Study Arms
Participants will be randomized into two groups: DHA-PPQ or placebo.
80%
Power Calculation
Statistical power to detect a significant decrease in malaria prevalence.
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