Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE-BC1)
This project has the objective to test the hypothesis that IPT with DP will significantly reduce the burden of malaria in pregnancy and infancy and improve the development of naturally acquired antimalarial immunity.
Birth cohort 1 study (BC-1) – This study enrolled 300 HIV uninfected pregnant women and randomized them to 3 different IPTp regimens. The children born to these mothers were then randomized to different IPTi regimens given through 2 years of age and then followed one additional year after chemoprevention was stopped.
ClinicalTrials.gov Identifier: NCT02163447
Study Phase: Phase 3
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of three intermittent preventive therapy in pregnancy (IPTp) treatment arms:
- 3 doses of sulfadoxine-pyrimethamine (SP)
- 3 doses of dihydroartemisinin-piperaquine (DP)
- monthly DP.
All three interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. In the second phase of the study, all children born to mothers enrolled in the study will be followed from birth until they reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding, children who will receive DP every 3 months will be given DP placebo during the months they will not be taking DP. Children will then be followed an additional year between 24-36 months of age following the interventions.