An interventional study of Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles and Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle in Nutrient Deficiency, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 1 site in Uganda. Open to participants aged 0 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Health services research
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:
Within the context of the existing antenatal care system, investigators will utilize qualitative and quantitative methods to answer the following research questions:
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.
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)
Exclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)
Inclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2)
Exclusion Criteria for Pregnant women / Women that have recently delivered (single contact) (sample 2)
Inclusion Criteria for ANC providers having ANC health education/counseling with pregnant woman(en) observed (sample 3)
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 to have the ANC session observed.
Inclusion Criteria for Influential family members (male partners \& mothers/mothers-in law) (sample 4)
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)
Exclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)
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)
Exclusion Criteria for National, regional, and district-level stakeholders (sample 7)
Inclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)
Exclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
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.
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
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
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