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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4077 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Nutrient Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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"

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

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).

Group Type ACTIVE_COMPARATOR