Iron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has found benefits of a multiple micronutrient supplement (MMS) over just IFA alone on several outcomes of perinatal and infant health. The Ministry of Health in Cambodia has proposed a transition from IFA to MMS but to effectively guide this transition requires implementation research on the acceptability and adherence to MMS (over IFA). This noninferiority trial aims to assess the adherence and acceptability of IFA (60mg elemental iron and 400μg folic acid) compared to MMS (standard UNIMMAP formulation including 15 micronutrients) during ante‑ natal care in Cambodia. A prospective cohort of 1545 pregnant women will be assigned to one of three trial arms: (1) IFA for 90days [IFA90]; (2) MMS for 180days with two distributions of 90count tablet bottles [MMS90]; or (3) MMS for 180days with one 180count tablet bottle [MMS180]. Each arm will enroll 515 women across 48 health centers (clusters) in Kampong Thom Province in Cambodia. The primary outcome is the noninferiority of adherence rates of MMS180 compared to IFA90, as assessed by tablet counts. Mixed effects logistic and linear regression models will be used to estimate the difference in the adherence rate between the two groups, with an ‘a priori’ determined noninferiority margin of 15%. Acceptability of MMS and IFA will be measured using a quantitative survey conducted with enrolled pregnant women at 30day, 90day, and 180day timepoints. Findings from this study will guide an effective and feasible MMS scaleup strategy for Cambodia. Additionally, the findings will be shared globally with other stakeholders planning to scale up MMS in other countries.
