Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia

AIM: The overall aim of the MMS evaluation is to evaluate the programme effectiveness on birthweight of providing MMS as part of routine antenatal care, relative to providing IFA.

STUDY DESIGN: This program effectiveness study involves a cluster randomized trial to estimate the effect of MMS on the primary outcome, birthweight, with embedded cost and process evaluations to measure the secondary objectives.

The overall study design is built around a two-arm, facility-based, cluster randomized trial with district as the unit of randomization (the cluster), whereby districts are randomized 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 IFA is removed from the standard antenatal care package and replaced with multi-micronutrient supplementation (MMS).

STUDY PERIOD: The entire MMS evaluation will continue for 42 months, starting in March 2022. During 2022, permissions will be obtained and protocols written. In January 2023, a system will be implemented for continuous recording of birth weights in all enrolled health facilities, running until end December 2024 (ie for 24 months). A facility survey will be implemented to collect process data for the secondary objectives at baseline (January 2023), midline (February 2024) and endline (February 2025). Data on costs will be collected alongside the midline facility survey. Primary analysis will be conducted during April 2025.

LOCATION: The evaluation will be done in 42 districts in five regions of Ethiopia. The districts were selected by the Ethiopian Ministry of Health as a pilot area to implement the switch from MMS to IFA as part of routine care, with the intention of also permitting the 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 implementation on the mean birthweight of babies born in government health facilities to women living in areas where MMS is implemented, relative to the mean birthweight of babies born in government health facilities to women living in areas where standard antenatal IFA supplementation is implemented.

PRIMARY OUTCOME: Birthweight measured as part of routine maternity care will be collected for all live births in enrolled health facilities in intervention and comparison areas.

The protocol for recording the primary outcome, birthweight, will align with routine practices in health facility maternity wards whereby midwives routinely document birthweight. Digital scales will be provided to facilities for this purpose, replacing manual scales. The study team will work with midwives to ensure training in appropriate use of digital scales, accurate recording of birthweight in grammes to four digits, and continuous 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 questions about how delivery is achieved and what is actually delivered (fidelity, dose, adaptations, reach and context) and the mechanisms of impact (how providers and clients respond to MMS and any unanticipated pathways or consequences)
• To assess the acceptability and adherence of MMS

SECONDARY ANALYSES AND OBJECTIVES: During the baseline, midline and endline facility surveys data collection tools include: (i) a structured tool to capture detailed information about the antenatal care received by women; (ii) a structured tool to collect data on costs of implementing MMS or IFA; (iii) a structured facility readiness assessment to collect data on availability of services, supplies and trained staff (iv) semi-structured interviews with facility staff on their experience of providing antenatal care services.

The need for additional qualitative interviews with health care users and health care providers to explore emerging topics regarding adherence and acceptability will be reviewed together with the implementation team when implementation has begun and after analysis of baseline data collection.

STUDY POPULATION: For the primary outcome, the study population are mother/infant dyads who are resident in study districts and who access childbirth care in the health centres of those districts. For the secondary objectives there are two study populations: (i) the health staff providing antenatal care services in health centres and (ii) women accessing antenatal care there.