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Nutrient DeficiencyNCT06835738

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

A study testing Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles, Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle and Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles in people with Nutrient Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Nutrient Deficiency
What is being tested?
Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles, Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle and Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,077 participants
Where
1 siteUganda
Study dates
18 Jun 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Inclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)

  • ≤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

Exclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)

  • 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.

Inclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2)

  • 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.

Exclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2)

  • Enrolled in study population 1.
  • Women who are more than 8 weeks postpartum.

Inclusion Criteria for ANC providers having ANC health education/counseling with pregnant woman(en) observed (sample 3)

  • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling at government or PNFP health facilities.

Exclusion Criteria for ANC providers having ANC health education/counseling with pregnant woman(en) observed (sample 3) • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling to a woman(en) that have not provided written informed consent to have the ANC session observed.

Inclusion Criteria for Influential family members (male partners \& mothers/mothers-in law) (sample 4)

  • 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.

Exclusion Criteria for Influential family members (male partners \& mothers/mothers-in law) (sample 4) • None

Inclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)

  • 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.

Exclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)

  • None

Inclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • Voluntary Health Team (VHT), Mentor Mothers, or Para-socials attached to at least one of the study facilities.

Exclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • None

Inclusion Criteria for National, regional, and district-level stakeholders (sample 7)

  • 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.
  • Implementing partners involved in direct implementation of MMS within the 8 study districts

Exclusion Criteria for National, regional, and district-level stakeholders (sample 7)

  • None

Inclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)

  • Woman who has been pregnant or delivered within the study period.
  • Household is within one of the 4 selected districts.

Exclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)

  • Women who moved to the district after delivery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Harriet Babikako, PhD contact

256-0704-584-089

babikako@yahoo.com

Uganda1 site, 1 recruiting
  • Lyantonde GH

    Lyantonde

    Lilian Tabwenda

    Recruiting

Other trials in Uganda

About this study

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
Read the detailed description

Within the context of the existing antenatal care system, investigators will utilize qualitative and quantitative methods to answer the following research questions:

  1. What is the acceptability, feasibility, fidelity, coverage, and potential for sustainability of an MMS intervention that includes MMS product, a contextualized social behavior change communication (SBCC) plan, capacity strengthening, and modified recording and reporting).
  2. Does the number of MMS pills in a bottle affect/influence adherence to MMS and/or attendance at ANC attend (30 count bottle vs 90 count bottle vs 180-count bottle).
  3. What is the cost and budget impact of implementing MMS intervention within the antenatal care (ANC( service delivery system in Uganda.

This is a 3-arm quasi-experimental implementation research (IR) study utilizing a mixed methods data collection approach across multiple study populations (e.g., national, regional, and district-level decision makers, healthcare providers, pregnant women, and other community members). The three study arms are: Study Arm #1 (MMS 180-count), Study Arm #2 (MMS 30-count) and Study Arm #3 (MMS 90-count).

The IR will be conducted in 8 districts representing the South Central, Acholi, and Karamoja regions of Uganda. Sufficient MMS will be provided to the 8 districts to ensure full implementation of MMS across all government (public) facilities and private not-for-profit (PNFP) facilities within the 8 study districts. In other words, all pregnant women who attend ANC through either a public or PNFP health facility within the 8 study districts will be offered MMS rather than IFA.

Each district will be assigned to receive a specific "bottle-count" to be provided to all pregnant women attending ANC in that district. All women will be provided with 180 tablets of MMS delivered in the "bottle-count" option assigned to the district where she is seeking services. The 3 "bottle-count" options are: 1) 1 bottle containing 180 tablets dispensed to the pregnant woman attending the first ANC visit; 2) 2 bottles each containing 90 tablets of MMS dispensed at two different time points during pregnancy; or 3) 6 bottles each containing 30 tablets of MMS dispensed monthly over the course of a woman's pregnancy). All pregnant women who are assigned to a 30 or 90 bottle count will continue with that bottle count throughout the women's life of pregnancy and postpartum period.

Each "bottle-count" equates to a study arm. Each of the 3 study regions will have slightly different study arms. The districts/study arms within each region were purposively selected under the formative (phase I) of the study. Because there are 3 districts in both the South-Central Region and the Acholi region, each of the 3 districts will serve as a study arm representing one of the three "bottle-count" options. Because there are only 2 districts in the Karamoja region, there will not be a 90-count study-arm.

The study will undertake data collection at approximately 6 facilities per district, representative of the total number of facilities in the districts. Facilities will be purposively selected after being stratified based on the level of the health facility (health center II, health center III, health center IV, or hospital), ownership (government or PNFP), and geographic location.

Being tested
Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles, Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle, Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottlesDietary 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 bottleDietary 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 bottlesDietary 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.

Study groups in NCT06835738
Study groupRoleWhat they receive
Enhanced MMS delivery with six 30-count bottles (standard packaging amount for IFA)Active comparatorPregnant 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).
Receives: Dietary Supplement: Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles
Enhanced MMS delivery with one 180-count bottleActive comparatorPregnant 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).
Receives: Dietary Supplement: Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle
Enhanced MMS delivery with two 90-count bottlesActive comparatorPregnant 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).
Receives: Dietary Supplement: Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

    Measured: 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)

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

Secondary outcomes (3)
  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.

    Measured: 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).

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start18 Jun 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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"
Masking
None (open label)
Enrolment
4,077 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835738
Sponsor's protocol ID
IRB00022536/MOD5681
Status last verified
Sep 2026
First submitted
14 Feb 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles, Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle and Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles in people with Nutrient Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harriet Babikako, PhD (256-0704-584-089, babikako@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MMS Adherence (amount) as assessed by number of MMS tablets consumed (time frame: 3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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