protocolSection identificationModule nctId: NCT06327646, orgStudyIdInfo id: 66677, briefTitle: Maternal Adherence to MMS in Nepal, acronym: NAMASTE MMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Helen Keller International, class: OTHER, collaborators name: Eleanor Crook Foundation, descriptionModule briefSummary: Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned., conditionsModule conditions: Supplementation, conditions: Pregnancy Related, conditions: Postnatal Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 2640, type: ESTIMATED, armsInterventionsModule interventions name: Multiple Micronutrient Supplement Blister, interventions name: Multiple Micronutrient Supplement Bottle, interventions name: Iron Folic Acid Blister, outcomesModule primaryOutcomes measure: 180 days adherence: MMS (2 types) vs. IFA, secondaryOutcomes measure: 30, 90, and 225 days adherence, secondaryOutcomes measure: 180 adherence: MMS blister vs MMS bottle, secondaryOutcomes measure: MMS acceptability, secondaryOutcomes measure: Antenatal Care Utilization at 180 days, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False