Maternal Adherence to MMS in Nepal

Summary

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.

Conditions

• Supplementation

Interventions

DRUG

Multiple Micronutrient Supplement Blister

MMS in a blister pack along with related job aids, counselling during ANC, etc.

DRUG

Multiple Micronutrient Supplement Bottle

MMS in bottles along with related job aids, counselling during ANC, etc.

DRUG

Iron Folic Acid Blister

Standard of Care - IFA in a blister pack along with related job aids, counselling during ANC, etc.

Sponsors & Collaborators

• Eleanor Crook Foundation

  collaborator UNKNOWN

• Johns Hopkins University

  collaborator OTHER

• Helen Keller International

  lead OTHER

Principal Investigators

• Rolf Klemm, PhD · Helen Keller International

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-04

Primary Completion

2025-07-24

Completion

2025-09-30

Countries

• Nepal

Study Locations