NCT06835738 Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda
| NCT ID | NCT06835738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Nutrient Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,077 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,077 participants in total. It began in 2025-06-18 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Monica Fox, MHS
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06835738 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 80 Years, studying Nutrient Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835738 currently recruiting?
Yes, NCT06835738 is actively recruiting participants. Contact the research team at babikako@yahoo.com for enrollment information.
Where is the NCT06835738 trial being conducted?
This trial is being conducted at Lyantonde, Uganda.
Who is sponsoring the NCT06835738 clinical trial?
NCT06835738 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Monica Fox, MHS at Johns Hopkins University. The trial plans to enroll 4,077 participants.