Healthy Mums, Healthy Babies: multiple Micronutrient Supplementation in Ethiopia

AIM: The overall aim of the MMS evaluation is to evaluate the programme effectiveness onbirthweight of providing MMS as part of routine antenatal care, relative to providingIFA.STUDY DESIGN: This program effectiveness study involves a cluster randomized trial toestimate the effect of MMS on the primary outcome, birthweight, with embedded cost andprocess evaluations to measure the secondary objectives.The overall study design is built around a two‐arm, facility‐based, cluster randomizedtrial with district as the unit of randomization (the cluster), whereby districts arerandomized to a comparison arm that continues to deliver iron‐folic acid supplementation(IFA) as part of the standard antenatal care package, or to an intervention arm where IFAis removed from the standard antenatal care package and replaced with multi‐micronutrientsupplementation (MMS).STUDY PERIOD: The entire MMS evaluation will continue for 42 months, starting in March2022. During 2022, permissions will be obtained and protocols written. In January 2023, asystem will be implemented for continuous recording of birth weights in all enrolledhealth facilities, running until end December 2024 (ie for 24 months). A facility surveywill be implemented to collect process data for the secondary objectives at baseline(January 2023), midline (February 2024) and endline (February 2025). Data on costs willbe collected alongside the midline facility survey. Primary analysis will be conductedduring April 2025.LOCATION: The evaluation will be done in 42 districts in five regions of Ethiopia. Thedistricts were selected by the Ethiopian Ministry of Health as a pilot area to implementthe switch from MMS to IFA as part of routine care, with the intention of also permittingthe RCT evaluation of that switch.42 Districts in detail: Gambella Region (2 districts): Itang especial woreda; Godere;Somali Region (4 districts): Kebribaya; Ararso; Awbare; Aware;Oromia Region (20 districts): Gursum; Deder; Goba Koricha; Bele Gesgar; Rayitu; Dodola;Wondo; Kersa; Ejere; Gimbichu; Gemechis; Adami Tulu Jido; Sire; Guna; Medawelabu; Dire;Arero; Becho; Jimma Arjo; Ejersa Lafoo;Southern Nations Nationalities, and People's Region (12 districts): Sodo; Enemor;Shahsego; Chencha Zuria; Atote Ulo; South Ari; Duguna Fango; Kachabira Bira; Silti;Wonago; Zala; Karat Zuria;Sidama Region (4 districts): Shebedino; Dara; Aleta chuko; Bona Zuria;PRIMARY OBJECTIVE: The primary objective is to estimate the effect of MMS implementationon the mean birthweight of babies born in government health facilities to women living inareas where MMS is implemented, relative to the mean birthweight of babies born ingovernment health facilities to women living in areas where standard antenatal IFAsupplementation is implemented.PRIMARY OUTCOME: Birthweight measured as part of routine maternity care will be collectedfor all live births in enrolled health facilities in intervention and comparison areas.The protocol for recording the primary outcome, birthweight, will align with routinepractices in health facility maternity wards whereby midwives routinely documentbirthweight. Digital scales will be provided to facilities for this purpose, replacingmanual scales. The study team will work with midwives to ensure training in appropriateuse of digital scales, accurate recording of birthweight in grammes to four digits, andcontinuous quality control measures including scale calibration.SECONDARY OBJECTIVES: ‐ To estimate the cost and cost‐effectiveness of the MMS intervention ‐ To investigate the processes of MMS implementation including addressing questionsabout how delivery is achieved and what is actually delivered (fidelity, dose,adaptations, reach and context) and the mechanisms of impact (how providers andclients respond to MMS and any unanticipated pathways or consequences) ‐ To assess the acceptability and adherence of MMSSECONDARY ANALYSES AND OBJECTIVES: During the baseline, midline and endline facilitysurveys data collection tools include: (i) a structured tool to capture detailedinformation about the antenatal care received by women; (ii) a structured tool to collectdata on costs of implementing MMS or IFA; (iii) a structured facility readinessassessment to collect data on availability of services, supplies and trained staff (iv)semi‐structured interviews with facility staff on their experience of providing antenatalcare services.The need for additional qualitative interviews with health care users and health careproviders to explore emerging topics regarding adherence and acceptability will bereviewed together with the implementation team when implementation has begun and afteranalysis of baseline data collection.STUDY POPULATION: For the primary outcome, the study population are mother/infant dyadswho are resident in study districts and who access childbirth care in the health centresof those districts. For the secondary objectives there are two study populations: (i) thehealth staff providing antenatal care services in health centres and (ii) women accessingantenatal care there.