Delivering prenatal multiple micronutrient supplements to pregnant women in Uganda

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

This project will test different MMS bottle sizes and delivery supports among pregnant women in Uganda to see which approach helps them take the supplements more regularly and attend antenatal care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 4077 (estimated)
• Ages: 0 Years to 80 Years
• Sex: All
• Sponsor: Johns Hopkins Bloomberg School of Public Health (other)
• Locations: 1 site (Lyantonde)
• Trial ID: NCT06835738 on ClinicalTrials.gov

What this trial studies

This is a three-arm quasi-experimental implementation study using mixed methods across eight districts in the South Central, Acholi, and Karamoja regions of Uganda. The study compares dispensing MMS in 30-, 90-, and 180-count bottles alongside a contextualized social behavior change communication plan, capacity strengthening, supply chain support, and monitoring to measure acceptability, feasibility, fidelity, coverage, sustainability, adherence, ANC attendance, and cost impact. Quantitative measures will track adherence, ANC visit patterns, coverage, and budget impact while qualitative interviews with decision makers, providers, pregnant women, and community members will explore implementation experiences. MMS will be supplied to public and private not-for-profit facilities in the selected districts and data collected from women enrolled early in pregnancy and from a separate sample of women who received MMS previously.

Who should consider this trial

Good fit: Ideal participants are pregnant women attending their first ANC visit at participating public or private-not-for-profit facilities in the selected districts, enrolled at ≤24 weeks gestation and willing to take MMS, with a separate single-contact sample including women ≤8 weeks postpartum who received MMS ≥3 months earlier.

Not a fit: Patients with pre-existing hematological disorders such as sickle cell disease, thalassemia, or hemochromatosis, those planning to relocate outside the study districts, or women who do not attend ANC at participating facilities are unlikely to benefit from this implementation intervention.

Why it matters

Potential benefit: If successful, the approach could increase supplement adherence and ANC attendance, improve maternal micronutrient status and birth outcomes, and support scaling MMS within routine ANC services in Uganda.

How similar studies have performed: Clinical trials have shown MMS can improve maternal micronutrient status and some birth outcomes compared with iron–folic acid, but large-scale implementation within national ANC systems like Uganda's is less well tested.

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.

Where this trial is running

Lyantonde

• Lyantonde GH — Lyantonde, Uganda (RECRUITING)

Study contacts

• Principal investigator: Monica Fox, MHS — Johns Hopkins University
• Study coordinator: Harriet Babikako, PhD

Conditions: Nutrient Deficiency