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Evaluation of the safety and efficacy of dihydroartemisinin–piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project)
Testing the safety and effectiveness of a malaria prevention treatment in pregnant women with HIV
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Abstract
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.
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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.