Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 1)
Brief Summary: 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: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of dihydroartemisinin-piperaquine (DP), or 3) 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. We will 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.


Options:
A: Arm Label: Mefloquine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mefloquine | Arm Label: Sulphadoxine-Pyrimethamine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sulphadoxine-Pyrimethamine | Intervention Type: DRUG; Name: Mefloquine; Assigned to Arm(s): Mefloquine | Intervention Type: DRUG; Name: Sulphadoxine-Pyrimethamine; Assigned to Arm(s): Sulphadoxine-Pyrimethamine
B: Arm Label: 3 dose SP pregnancy / 3 monthly DP infancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy, Drug: 3-monthly dihydroartemisinin-piperaquine (DP) for infants | Arm Label: 3 dose DP pregnancy / 3 monthly DP infancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, Drug: 3-monthly dihydroartemisinin-piperaquine (DP) for infants | Arm Label: 3 dose DP pregnancy / monthly DP infancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, Drug: Monthly dihydroartemisinin-piperaquine (DP) for infants | Arm Label: monthly DP pregnancy / 3 monthly DP infancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, Drug: 3-monthly dihydroartemisinin-piperaquine (DP) for infants | Arm Label: monthly DP pregnancy / monthly DP infancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, Drug: Monthly dihydroartemisinin-piperaquine (DP) for infants | Intervention Type: DRUG; Name: Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy; Assigned to Arm(s): monthly DP pregnancy / 3 monthly DP infancy, monthly DP pregnancy / monthly DP infancy | Intervention Type: DRUG; Name: 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy; Assigned to Arm(s): 3 dose DP pregnancy / 3 monthly DP infancy, 3 dose DP pregnancy / monthly DP infancy | Intervention Type: DRUG; Name: 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy; Assigned to Arm(s): 3 dose SP pregnancy / 3 monthly DP infancy | Intervention Type: DRUG; Name: Monthly dihydroartemisinin-piperaquine (DP) for infants; Assigned to Arm(s): 3 dose DP pregnancy / monthly DP infancy, monthly DP pregnancy / monthly DP infancy | Intervention Type: DRUG; Name: 3-monthly dihydroartemisinin-piperaquine (DP) for infants; Assigned to Arm(s): 3 dose DP pregnancy / 3 monthly DP infancy, 3 dose SP pregnancy / 3 monthly DP infancy, monthly DP pregnancy / 3 monthly DP infancy
C: Intervention Type: DRUG; Name: Monthly sulfadoxine/pyrimethamine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: 2-dose sulfadoxine/pyrimethamine; Assigned to Arm(s): N/A
D: Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sulfadoxine-pyrimethamine treatment twice during pregnancy | Arm Label: Monthly SP; Type: EXPERIMENTAL; Interventions: Drug: Sulfadoxine-pyrimethamine at 4-week intervals | Arm Label: AZI-SP; Type: EXPERIMENTAL; Interventions: Drug: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice | Intervention Type: DRUG; Name: Sulfadoxine-pyrimethamine treatment twice during pregnancy; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: Sulfadoxine-pyrimethamine at 4-week intervals; Assigned to Arm(s): Monthly SP | Intervention Type: DRUG; Name: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice; Assigned to Arm(s): AZI-SP

Answer: B