Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-80
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Uganda national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:

* Describe the implementation of the MMS intervention (which consists of MMS product, a social behavior change communication (SBCC) strategy, capacity building, MMS supply chain support, monitoring, and evaluation) and explore acceptability, feasibility, fidelity, coverage, and potential for sustainability. * Determine the effect of dispensing MMS in different bottle counts on MMS adherence and ANC attendance among pregnant women. * Determine the cost and budget impact of MMS intervention implementation integrated in the Ugandan ANC service delivery system

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≤24 weeks of amenorrhea/gestation as verified by health professionals

Attending first ANC visit at government or PNFP health facilities.

Accepted to take MMS at first ANC visit

Disqualifiers

Pregnant women with pre-existing hematological conditions such as sickle cell anemia, thalassemia, hemochromatosis.

Pregnant women planning to relocate outside the study district during the study period.

Currently pregnant woman or a woman who is not more than 8 weeks postpartum.

Received MMS at an ANC visit at least 3 months ago or more.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles

    Dietary supplement

    MMS is a daily supplement provided to pregnant women. It will be delivered to pregnant women through the specified bottle-count protocol as designated by the 3 study arms. ANC providers will be trained to counsel pregnant women on using MMS using a novel job aid/adherence calendar.

  • Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle

    Dietary supplement

    MMS is a daily supplement provided to pregnant women. It will be delivered to pregnant women through the specified bottle-count protocol as designated by the 3 study arms. ANC providers will be trained to counsel pregnant women on using MMS using a novel job aid/adherence calendar.

  • Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles

    Dietary supplement

    MMS is a daily supplement provided to pregnant women. It will be delivered to pregnant women through the specified bottle-count protocol as designated by the 3 study arms. ANC providers will be trained to counsel pregnant women on using MMS using a novel job aid/adherence calendar.

Treatment groups

4,077 Participants
are divided into 3 treatment groups
Group A: Enhanced MMS delivery with six 30-count bottles (standard packaging amount for IFA)Active comparator 1 intervention
Group B: Enhanced MMS delivery with one 180-count bottleActive comparator 1 intervention
Group C: Enhanced MMS delivery with two 90-count bottlesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

MMS Adherence (amount) as assessed by number of MMS tablets consumed

The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample 1).

Time frame
3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit
2

MMS Adherence (frequency) as assessed by the frequency of tablets consumed

The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1)

Time frame
3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit
3

ANC Adherence as assessed by the number of ANC visits throughout pregnancy

The number of ANC visits (from a total possible of 8 visits) a pregnant woman makes throughout her pregnancy (sample 1)

Time frame
3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit

Secondary outcomes

1

Proportion of pregnant women who indicate MMS Acceptability

The proportion of pregnant women (sample group 1 and 2) who agree with domain-specific statements which reflect different aspects of MMS acceptability (MMS packaging, MMS physical properties, MMS side effects, and MMS counseling using The Theoretical Framework of Acceptability uses a 5-point Likert scale where 5 is "strongly agree" and 1 is "strongly disagree". Score range 5-35, a higher score reflects higher acceptability.

Time frame
3-month post-enrolment visit, 6-month post-enrolment visit, 6-week postpartum visit
2

MMS Acceptability among Health Providers assessed by focus group discussions

Healthcare provider acceptability of MMS across multiple domains (e.g., feasibility of delivering counseling and packaging, time burden) (sample group 5). Measured via focus group discussions at two time points during the study (middle and end).

Time frame
6 months, 12 months
3

Fidelity of providing MMS among Health Providers as assessed by focus group discussions

Administration of an observation checklist (sample group 3) and a Healthcare Provider Survey (sample 5) at 4 time points during the study

Time frame
3-months, 6-months, 9-months, and 12-months

Other outcomes

1

Number of pregnant women being given 180 tablets of MMS

MMS coverage as assessed by the number of pregnant women or recently pregnant women (sample 8) reporting having been given 180 tablets of MMS as compared to the estimated number of pregnant women in the population (e.g., within the 8 study districts) via post-implementation household survey.

Time frame
14 months

Sponsors and contacts

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Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Vitamin Angels

Collaborator

UNICEF

Collaborator

Child and Family Foundation of Uganda

Collaborator

Kirk Humanitarian

Collaborator