International Health, Johns Hopkins Bloomberg School of Public Health
Evaluation of malaria and HIV burden and pregnancy outcomes
We propose to conduct a clinical study to estimate the burden of malaria in pregnant women in Myanmar, in close collaboration with the Departments of Health, Ministry of Health. The primary objective is to estimate the case load of acute uncomplicated malaria and asymptomatic malaria parasitemia in pregnant women with or without HIV. The secondary objective is to evaluate the feasibility of efficient accrual and recruitment for a subsequent larger clinical trial to assess the efficacy and safety of artemisinin-based combination therapy (ACT) in pregnant women living with HIV. The major goal of the subsequent clinical trial is to systematically evaluate host, parasite and pharmacologic factors influencing the rate of parasite clearance and the overall success or failure of ACT treatment outcomes in pregnant women, with an ultimate goal of developing a pharmacokinetic-based dosing regimen to optimize treatment outcomes in this vulnerable population. A total of up to 2,000 pregnant women will be enrolled from a clinic where antenatal care and/or HIV testing/care services are offered. Baseline clinical and laboratory data will be collected. The numbers of cases of acute uncomplicated malaria and asymptomatic parasitemia in a specified study period will be calculated. Malaria cases will be treated with a standard ACT. Pregnancy outcomes and the presence of placental malaria will be assessed. Study findings will provide the estimate of malaria case load and disease burden in the targeted study population, which is essential to determine for the feasibility of the future clinical trial and for the calculation of an adequate sample size.