Maternal Adherence to MMS in Nepal (NAMASTE MMS)

Helen Keller International

Status: Active, not recruiting

Conditions: Supplementation

Treatments: Drug: Multiple Micronutrient Supplement Bottle; Drug: Iron Folic Acid Blister; Drug: Multiple Micronutrient Supplement Blister

Study type: Interventional

Funder types: Other

Identifiers

NCT06327646

66677

Details and patient eligibility

About

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.

Full description

The primary and secondary research questions for the randomized controlled trial named "Non-inferiority Assessment of Maternal Adherence to Supplementation: A Trial of the Effects of MMS" (NAMASTE MMS) are detailed below:

Primary:

1. Is adherence to the full prescription of 180 MMS (-blister) during pregnancy non-inferior to adherence to the full prescription of 180 IFA-blister during pregnancy (arm 2 vs arm 1)?
2. Is adherence to the full prescription of 180 MMS (-bottle) during pregnancy non-inferior to adherence to the full prescription of 180 IFA-blister during pregnancy (arm 3 vs arm 1)?

Secondary:

1. Is the level of adherence to MMS-blister and MMS-bottle non-inferior to the level of adherence to IFA-blister at different points during pregnancy and lactation (i.e. 30 days, 90 days, and 45 days postpartum from start of supplementation) (arm 2 vs. arm 1 and arm 3 vs arm 1)?
2. Is there a difference in adherence to 180 MMS during pregnancy from blister packaging vs bottle packaging of MMS (arm 2 vs arm 3?
3. Is there a difference in adherence to ANC visits during pregnancy from blister packaging vs bottle packaging of MMS (arm 2 vs arm 3)?
4. What is the level of acceptability of IFA and MMS at different stages of pregnancy (i.e. 30 days, 90 days, 180 days, and 45 days postpartum) (arms 1, 2 and 3)?
5. What is the validity of women's recall of the amount of MMS/IFA received and of adherence to MMS/IFA compared to a gold standard?

This c-RCT will be conducted among pregnant women assigned to one of three trial arms (as described below in the section on interventional description). Data will be collected via in-person surveys at their home over a period of 12 months, including immediately following the 30-, 90-, delivery (180-) and 45-days post-partum (225-) day points post-enrollment at the pregnant woman's first antenatal care visit.

The c-RCT will be conducted in Lumbini Province of Nepal, which was purposely selected among the four provinces that cover all three agro-ecological regions in Nepal: mountains, hills, and the terai (plains) due to ease of implementation. The random sampling of health facilities (clusters) will be as proportional to the population as possible - i.e., 10% from mountains, 40% from hills, and 50% from terai. The required facilities (n=120) will be randomly selected and assigned to one of the three c-RCT arms using from the list of government health facilities (primary health care centers (PHCCs), and health posts (HPs) only).

A total of 120 health facilities will be randomly assigned to one of the three arms. Forty (40) health facilities will receive IFA in blister packs (current standard of care), 40 health facilities will receive MMS in blister packs, and 40 will receive MMS in bottles, and 40 will receive IFA in blister packs. These supplements will be distributed pregnant women who health workers identify as meeting study criteria and who provide verbal informed consent to be study participants. When a woman reports for antenatal care to a health facility that is part of the RCT, the health worker will identify whether she is at least 18 years and no more than 35 years of age. If so, the health work will start to complete an enrollment log (Annex 4) to document the pregnant woman's details such as name, phone number, other household members' phone number(s), and house location details. This enrollment log also includes the study eligibility criteria (specified below) to help the health worker know if the woman could participate in the study. If she is deemed eligible, the health worker will inform her about the study and the opportunity to participate including the research objectives and processes and share detailed information on supplementation including its timing, benefits, and potential side effects. The enrollment log thus will generate a record of all pregnant women considered for the study, those excluded by each of the study inclusion criteria, and the refusal rate for the study, based on the health worker's initial screening. The health worker will share information for each pregnant woman deemed to meet study inclusion criteria and who agrees to participate in the study with the enumerator assigned to that particular health facility, following a communication protocol (Annex 5). The enumerator will, in turn, enter the woman's data into his/her electronic enrolment log, visit the woman at her home to verify her eligibility based on the inclusion/exclusion criteria, and obtain her written informed consent. For those women who are confirmed to meet study inclusion/exclusion criteria and provide their written informed consent to participate, the enumerator will then administer the enrollment survey. Pregnant women enrolled in the study who continue to provide consent and remain in the study will be further interviewed at 30 and 90-days post enrollment, as well as at delivery (approximately 180-days post enrollment) and 45-days post-partum (approximately 225-days post enrollment)

The recruitment of pregnant women will continue in each health center facility on a rolling basis until the targeted number of women (2,640) total are enrolled. Recruitment is anticipated to take approximately 8 months, with quicker data collection in the plains given a larger number of pregnant women using services from these facilities and progressively slower data collection in the hills and mountains, due to lower population and in turn, less frequent pregnancies, and service usage . Additional delays in recruitment may occur due to adverse weather, greater clarity on pregnancy rates once enrollment starts, and other factors

Enrollment: 2,640 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

To be eligible for the study, health facilities must meet four criteria:

1. public/government-run;
2. either a PHCC or HP at point of randomization;
3. implement the standard ANC package of care; and
4. have the top 50% average monthly caseloads for newly enrolled pregnant women (i.e. first ANC) for that specific agro-ecological zone (mountains - at least 5/month; hill - at least 8/month; and terai - at least 15/month) based on health management information system (HMIS) ANC data (July 16, 2021, to July 15, 2022).

To be eligible for the study, pregnant women must meet multiple criteria, at the point of enrollment:

1. be 18 - 35 completed years of age at health facility enrollment;
2. not planning to move/migrate for at least nine months after enrollment;
3. gestational age of at least 12 but not yet 14 weeks at time of health facility enrollment, estimated based on her last menstrual period (LMP) with exact calendar calculation confirmed during visit by enumerator;
4. pregnancy without any complications; not classified as severe anemic as well as high-risk pregnancy (i.e. not having the following conditions: diabetes, polycystic ovary syndrome, thyroid disease, kidney diseases, fibroids and severe mental/physical conditions that prevent study participation including unable to speak, attend ANC/PNC, take supplements or mental/cognitive impairment);
5. provides written informed consent to participate in the study; and
6. agrees to have enumerators visit the home at different data collection points.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,640 participants in 3 patient groups

IFA-180 (Blister)

Active Comparator group

Treatment:

Drug: Iron Folic Acid Blister

MMS-180 (Blister)

Experimental group

Treatment:

Drug: Multiple Micronutrient Supplement Blister

MMS-180 (Bottle)

Experimental group

Treatment:

Drug: Multiple Micronutrient Supplement Bottle