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Mashi Study: Mother to Infant Transmission In March of 2001, the BHP initiated a randomized trial in Botswana known as the Mashi Study (Mashi means milk in Setswana). The study was initially designed to 1) evaluate the benefit of adding a single dose of the drug nevirapine (NVP) to the mom and baby to the existing zidovudine (ZDV) based Botswana National PMTCT Program, and 2) evaluate 6 months of exclusive breastfeeding with 6 months of ZDV infant prophylaxis as a safe alternative to formula feeding with 1 month of ZDV infant prophylaxis. In the second half of 2002, the Mashi study underwent several modifications. First, in response to data presented at the XIV International AIDS Conference (Barcelona, July 2002) demonstrating that a combination of NVP and ZDV is superior to ZDV alone for PMTCT, the Mashi study protocol was modified to ensure that all babies participating in the study receive a single dose of NVP. Mothers enrolled in the study continue to receive either a single dose of NVP or NVP placebo at the onset of labor. ZDV administration continues without modification. The amended protocol will evaluate whether the maternal NVP dose is a necessary component of a MTCT prevention regimen that also includes maternal and infant ZDV plus infant NVP. Second, in response to the initiation of free antiretroviral medications through MASA (Botswana's National Pilot Antiretroviral Treatment Program), the government has made the provision of free antiretroviral treatment available to potential Mashi participants (whether or not they chose to participate in the study), based upon national eligibility criteria. For more information about the MASA Program click here. The Mashi study is being conducted in 3 rural sites (Molepolole, Mochudi and Lobatse) and one urban site (Gaborone). At the end of 2002, nearly 800 mother-infant pairs had been enrolled in the study. With a current accrual rate of 50 women per month, the study should reach the enrollment target of 1200 women by the end of September 2003. The outcomes of this study will have important ramifications for MTCT prevention programs in Southern Africa and throughout the developing world.
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