Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06327646 |
| Other study ID # |
66677 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2024 |
| Est. completion date |
July 20, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Helen Keller International |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)?
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-, 180- and 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 to study
participants only. When a pregnant woman reports for her first antenatal care visit to a
health facility that is part of the RCT, the health worker will use eligibility criteria
(specified below)gestational age of not more than 14 weeks at time of enrollment; pregnancy
without any complications at first ANC visit; not classified as a high-risk pregnancy - not
having the following conditions: diabetes, polycystic ovary syndrome, thyroid disease, kidney
diseases, fibroids) to assess her eligibility for inclusion 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, a detailed brief
information onf supplementationMMS includingand its timing, benefits, and potential side
effects, and a summary of the evidence on its effectiveness. The record of all pregnant women
considered for the study and of the eligible women for inclusion in the study will be
maintained in an enrolment log (Annex - 4). If theFor each womaen who expresses her
willingness to participate in the study, the health worker will document her extra details in
the separateregister her details in the study enrollment log, i provided by the study team,
including her name, phone number, other household members' phone number(s), and house
location details. This information will be shared with enumerators assigned to that health
centerfacility . These enumerators will then contact visit the woman at her home to verify
her eligibility based on the inclusion/exclusion criteria, . Enumerators will then visit the
pregnant women at their respective houses, obtain written informed consent, and administer
the enrollment questionssurvey. Subsequently, each pregnant woman will be revisited at their
home at 30, 90, 180, and 225 -days post-enrollment for data collection.
The recruitment of pregnant women will continue in each health center facility on a rolling
basis until the targeted number of women are enrolled. Recruitment is anticipated to take
approximately 3 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 .
