Maternal Adherence to MMS in Nepal

Not Applicable

Active, not recruiting

• Conditions: Supplementation
• Interventions: Drug: Iron Folic Acid Blister; Drug: Multiple Micronutrient Supplement Blister; Drug: Multiple Micronutrient Supplement Bottle

• Registration Number: NCT06327646
• Lead Sponsor: Helen Keller International

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Study Start: 2024-07-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-07-24
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2640

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFA-180 (Blister)	Iron Folic Acid Blister	-
MMS-180 (Blister)	Multiple Micronutrient Supplement Blister	-
MMS-180 (Bottle)	Multiple Micronutrient Supplement Bottle	-

Primary Outcome Measures

Name	Time	Method
Pregnancy supplementation for 180 days: binary	Delivery	Consumed at least 180 supplement tablets between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister)
Pregnancy supplementation for 180 days: continuous	Delivery	Number of supplements consumed between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister)

Secondary Outcome Measures

Name	Time	Method
MMS supplementation for 180 days: continuous	Delivery	Number of supplements consumed between study enrollment and delivery (MMS-blister vs. MMS-bottle)
Full pregnancy supplementation: binary	Delivery	Consumed at least the maximum number of supplement tablets eligible to consume between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister; MMS-bottle vs MMS-blister)
MMS supplementation for 180 days: Binary	Delivery	Consumed at least 180 supplement tablets between study enrollment and delivery (MMS-blister vs MMS-bottle)
Full pregnancy supplementation: continuous	Delivery	Number of supplements consumed between study enrollment and delivery (MMS-blister vs IFA-blister; MMS-bottle vs. IFA blister; MMS-bottle vs MMS-blister)
Antenatal Care Utilization: continuous	Delivery	Number of ANC visits during pregnancy (MMS-blister vs. MMS-bottle)
Antenatal Care Utilization: binary	Delivery	Received the recommended 8 ANC visits during pregnancy or not (MMS-blister vs MMS-bottle)

Trial Locations

Locations (118)

Satbariya Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Shantinagar Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Sisahaniya Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Chanai Health Post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Ganeshpur health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Gugauli health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Jahadi health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Krishnanagar health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Labani health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Maharajgunj primary health care centre; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Pakadi health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Nuwagaun Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Pakhapani Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Pang Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Rank Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Sirpa Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Sulichaur Phc; 🇳🇵 Rolpa, Lumbini Province, Nepal

Hukam Health Post; 🇳🇵 Rukum east, Lumbini Province, Nepal

Kankri Health Post; 🇳🇵 Rukum east, Lumbini Province, Nepal

Pokhara Health Post; 🇳🇵 Rukum east, Lumbini Province, Nepal

Sisne Health Post; 🇳🇵 Rukum east, Lumbini Province, Nepal

Aama Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Amuwa (Paschhim) Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Asurena Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Bodabar Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Chhapiya Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Dhamauli Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Ekala Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Farena Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Gajedi Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Gonaha Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Harnaiya Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Jogada Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Masina Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Bejapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Belahari health post; 🇳🇵 Banke, Lumbini Province, Nepal

Betahani health post; 🇳🇵 Banke, Lumbini Province, Nepal

Thada primary health care centre; 🇳🇵 Arghakhanchi, Lumbini Province, Nepal

Banakatawa primary health care centre; 🇳🇵 Banke, Lumbini Province, Nepal

Banakatti health post; 🇳🇵 Banke, Lumbini Province, Nepal

Basudevapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Chisapani health post; 🇳🇵 Banke, Lumbini Province, Nepal

Ganapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Gangapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Hirminiya health post; 🇳🇵 Banke, Lumbini Province, Nepal

Holiya health post; 🇳🇵 Banke, Lumbini Province, Nepal

Indrapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Jaispur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Kalaphata health post; 🇳🇵 Banke, Lumbini Province, Nepal

Kathkuiya health post; 🇳🇵 Banke, Lumbini Province, Nepal

Khajura primary health care centre; 🇳🇵 Banke, Lumbini Province, Nepal

Khaskarkado health post; 🇳🇵 Banke, Lumbini Province, Nepal

Laxmanpur primary health care centre; 🇳🇵 Banke, Lumbini Province, Nepal

Matahiya health post; 🇳🇵 Banke, Lumbini Province, Nepal

Narainapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Phattepur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Puraina health post; 🇳🇵 Banke, Lumbini Province, Nepal

Puraini health post; 🇳🇵 Banke, Lumbini Province, Nepal

Rainyapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Saigaun Health Post; 🇳🇵 Banke, Lumbini Province, Nepal

Sonpur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Titihiriya health post; 🇳🇵 Banke, Lumbini Province, Nepal

Udarapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Udayapur health post; 🇳🇵 Banke, Lumbini Province, Nepal

Khairapur health post; 🇳🇵 Bardiya, Lumbini Province, Nepal

Mathura haridwar health post; 🇳🇵 Bardiya, Lumbini Province, Nepal

Motipur health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Neulapur health Post; 🇳🇵 Bardiya, Lumbini Province, Nepal

Sanoshree health post; 🇳🇵 Bardiya, Lumbini Province, Nepal

Gadhawa Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Hapur Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Lalmatiya Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Laxmipur Health Post; 🇳🇵 Dang, Lumbini Province, Nepal

Baskhor health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Birpur health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Haranampur primary health care centre; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Hariharpur healthpost; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Patariya health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Pathardeiya health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Shivapur health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Sisawa health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Tilaurakot health post; 🇳🇵 Kapilvastu, Lumbini Province, Nepal

Jagnnathpur Primary Health Care Centre; 🇳🇵 Nawalparasi west, Lumbini Province, Nepal

Paklihawa health post; 🇳🇵 Nawalparasi west, Lumbini Province, Nepal

Arkha Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Bangeshal Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Bhingri Primary Health Care Centre; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Damri Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Devisthan Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Okharkot Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Phopli Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Rajwara Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Sapdanda Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Syauliwang Health Post; 🇳🇵 Pyuthan, Lumbini Province, Nepal

Aresh Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Holeri Phc; 🇳🇵 Rolpa, Lumbini Province, Nepal

Liwang Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Nerpa Health Post; 🇳🇵 Rolpa, Lumbini Province, Nepal

Taksera Health Post; 🇳🇵 Rukum east, Lumbini Province, Nepal

Bhagawanpur Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Dhakadhai Primary Health Care Centre; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Kamahariya Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Karmahawa Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Khudabagar Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Lumbini Primary Health Care Centre; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Majhagawa Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Manmateriya Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Motipur primary health care centre; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Parroha Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Roinihawa Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Rudrapur Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Sadi Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Sakraun Pakadi Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Semara Bazar Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Shankarnagar Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Sikatahan Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Sipawa Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal

Tenuhawa Health Post; 🇳🇵 Rupandehi, Lumbini Province, Nepal