About this trial
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
This trial accepts healthy volunteersQualifiers
≤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
Disqualifiers
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.
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.
Trial design
Parallel
Treatments tested in this trial
Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles
Dietary supplementMMS 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 bottle
Dietary supplementMMS 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 bottles
Dietary supplementMMS 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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)
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)
Secondary outcomes
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.
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).
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
Other outcomes
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.
Sponsors and contacts
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Vitamin Angels
Collaborator
UNICEF
Collaborator
Child and Family Foundation of Uganda
Collaborator
Kirk Humanitarian
Collaborator