Evaluation of an Intervention for Optimizing Pregnant Women's Adherence to Maternal Multiple Micronutrients Supplements

Research has shown that antenatal multiple micronutrient supplementation (MMS), a daily dose of 15 vitamins and minerals, is just as effective as iron and folic acid supplementation (IFAS) in preventing maternal anaemia, more effective at improving birth outcomes and is safe for mothers and babies.

In 2020, the World Health Organization (WHO) released an updated guidance recommending that implementation research (IR) be conducted in settings where the transition from IFAS to MMS is being considered in low- and middle- income countries. IR can help countries understand how to best design and implement effective intervention in real-life settings and can be used to identify and investigate challenges that prevent effective implementation.

In line with the WHO's recommendation, in 2021, the Nigeria Federal Ministry of Health approved the use of MMS during pregnancy and called for implementation research (IR) in the updated National Guidelines for the Prevention and Control of Micronutrient Deficiencies in Nigeria.

Based on national stakeholders' identification of a critical need for context-specific implementation evidence, efforts focused on understanding how MMS can be effectively delivered, accepted, and adhered to within the Nigerian health system, particularly in light of the implementation bottlenecks and adherence gaps previously documented in IFAS programs.

This IR project aims to evaluate implementation approaches on optimizing pregnant women's adherence to MMS. One of the components of this IR project is an outcome evaluation - the focus of this protocol - that seeks to answer the following research questions:

Primary research questions:

• Does implementation of these implementation approaches increase pregnant women's adherence to MMS?

Secondary research questions:

• Are the implementation approaches acceptable to key stakeholders?
• Does implementation of the implementation approaches increase the quality of care/nutrition counseling in ANC?

The implementation approaches focused on:

• Strengthening the capacity building of healthcare workers and community members
• Improving nutrition counselling integrated into ANC delivery with an emphasis on MMS adherence
• Engaging pregnant woman's family members (husbands) and influential community members to support maternal health and nutrition

An outcome evaluation was completed using a cluster randomized controlled trial (cRCT) with cross-sectional baseline (prior to the introduction of the implementation approaches) and endline (approximately 2 years after the introduction of the introduction of the implementation approaches) surveys among pregnant women, their husbands and healthcare workers (HCWs) across the three Local Government Areas (LGAs) in Bauchi State. MMS was integrated into routine ANC across the state prior to the baseline assessment.

Nutrition International worked closely with the Bauchi state government to select 3 LGAs (Dass, Ganjuwa and Giade) representing the north, central and southern parts of the state. This decision was made taking into consideration state representation key criteria such as religious demographic, ANC attendance, security, IFA utilization and socio-economic distribution. These LGAs comprise a total of 42 wards all of which were designated as study clusters for the intervention and control arms. Out of these 42 wards, a simple random selection was used to randomly allocate 22 wards to the intervention arm and 20 to the control arm across the three target LGAs:

• Control arm: Eligible pregnant women in these study sites receive MMS as part of their standard ANC.
• Intervention arm: Eligible pregnant women in these study sites receive MMS alongside the implementation approaches as part of their standard ANC.

A third observational arm was selected from a separate LGA where MMS had not been introduced and IFAS continued to be the standard of care to help contextualise differences between the intervention and control arms.

Quantitative and qualitative data were collected from participants through interviewer-administered questionnaires and focus group discussions. The study measured adherence through several methods including self-reported daily consumption, average consumption rate over a three-month period, and a physical pill count by the data collector. Difference-in-difference analysis will be used to assess whether the implementation approaches increased MMS adherence at endline. Descriptive statistics will be used to determine whether the adherence solutions are acceptable to healthcare workers, pregnant women, and their husbands.

Inclusion criteria

Pregnant/post-partum women

• Women of reproductive age (15-49 years of age)
• Pregnant or up to 3 months post-partum women
• Having reportedly received at least one MMS bottle at least 30 days before start of data collection from a participating public health facility-
• Provide consent for participation

Health Care Workers (HCWs)

• HCWs providing ANC services including MMS and IFAs to pregnant women at the selected health facilities

Husbands

• Husbands of the enrolled pregnant women At endline, the same criteria apply.

Exclusion criteria

• Anemic pregnant women