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

NCT06835738 | Recruiting

• 1 other identifier: IRB00022536/MOD5681
• Study Type: interventional
• Target: 4,077
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutrient Deficiency

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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)

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

• 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)

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

Secondary Outcomes (3)

• Proportion of pregnant women who indicate MMS Acceptability

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

• MMS Acceptability among Health Providers assessed by focus group discussions

  6 months, 12 months

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

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

Other Outcomes (1)

• Number of pregnant women being given 180 tablets of MMS

  14 months

Study Arms (3)

Enhanced MMS delivery with six 30-count bottles (standard packaging amount for IFA)

ACTIVE COMPARATOR

Pregnant women are provided with six 30-count bottles of MMS monthly during pregnancy, along with the novel job aid/adherence calendar and associated enhanced MMS counseling (1 district within each of the 3 study regions).

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

Enhanced MMS delivery with one 180-count bottle

ACTIVE COMPARATOR

Pregnant women are provided with one 180-count bottle of MMS at the first ANC visit, along with the novel job aid/adherence calendar and associated enhanced MMS counseling (1 district within each of the 3 study regions).

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

Enhanced MMS delivery with two 90-count bottles

ACTIVE COMPARATOR

Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with the novel job aid/adherence calendar and associated enhanced MMS counseling (1 district within 2 of the study regions (e.g., 2 districts).

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

Interventions

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.

Enhanced MMS delivery with six 30-count bottles (standard packaging amount for IFA)

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.

Enhanced MMS delivery with one 180-count bottle

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.

Enhanced MMS delivery with two 90-count bottles

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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

You may not qualify if:

• 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.
• Attended at least any 2 monthly ANC visits.
• Attending/attended ANC at government or private-not-for-profit health facility.
• Enrolled in study population 1.
• Women who are more than 8 weeks postpartum.
• Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling at government or PNFP health facilities.
• Spouse or partner of a pregnant woman or woman with a child less than 8 weeks old who is receiving/ has received ANC services in one of the 8 study districts.
• Mother or mother-in-law of a pregnant woman or woman with a child less than 8 weeks old who is receiving/ has received ANC services in one of the 8 study districts.
• Health workers who provide ANC services (e.g., midwives/nurse, medical/ clinical officers, health assistants, and nutrition focal person) at government or private-not-for-profit facilities in one of the 8 study districts.
• Health facility staff (e.g., Facility In-charge, Maternity In-charge, Pharmacy/Stores In-charge) at government or private-not-for-profit facilities in one of the 8 study districts.
• None
• National, regional, or district-level decision-makers working in nutrition, maternal, newborn and child health, district health educator or pharmaceutical roles associated with the antenatal care system in Uganda.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Vitamin Angels: collaborator
• UNICEF: collaborator
• Child and Family Foundation of Uganda: collaborator
• Kirk Humanitarian: collaborator

Study Sites (1)

Lyantonde GH

Lyantonde, Uganda

RECRUITING

Study Officials

• Monica Fox, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harriet Babikako, PhD

CONTACT

256-0704-584-089; babikako@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MMS will be implemented across 8 districts in Uganda within 3 regions of Uganda. Two regions have 3 study districts/arms and one region (Karamoja) has two study districts/arms. Study arms/districts have been purposively selected. * Study Arm 1 (3 districts): Provision of 6 bottles each containing 30 tablets of MMS dispensed monthly over the course of a woman's pregnancy). along with the novel "job aid/adherence calendar" * Study Arm 2 (3 districts): Provision of 1 bottle containing 180 tablets dispensed to the pregnant woman attending the first ANC visit; along with the novel "job aid/adherence calendar" * Study Arm 3 (2 districts): Provision of 2 bottles each containing 90 tablets of MMS dispensed at two different time points during pregnancy along with the novel "job aid/adherence calendar"

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)