Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,077
- 试验地点
- 1
- 主要终点
- MMS Adherence (amount) as assessed by number of MMS tablets consumed
研究概览
简要总结
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
详细描述
Within the context of the existing antenatal care system, investigators will utilize qualitative and quantitative methods to answer the following research questions:
- 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).
- 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).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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)
- •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)
- •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.
研究组 & 干预措施
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).
干预措施: Multiple Micronutrient Supplement (MMS) - dispensed in six 30-count bottles (Dietary Supplement)
Enhanced MMS delivery with one 180-count bottle
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).
干预措施: Multiple Micronutrient Supplement (MMS) - dispensed in one 180-count bottle (Dietary Supplement)
Enhanced MMS delivery with two 90-count bottles
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).
干预措施: Multiple Micronutrient Supplement (MMS) - dispensed in two 90-count bottles (Dietary Supplement)
结局指标
主要结局
MMS Adherence (amount) as assessed by number of MMS tablets consumed
时间窗: 3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit
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
时间窗: 3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit
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
时间窗: 3-month post-enrolment, 6-month post-enrolment visit, 6-week postpartum visit
The number of ANC visits (from a total possible of 8 visits) a pregnant woman makes throughout her pregnancy (sample 1)
次要结局
- Proportion of pregnant women who indicate MMS Acceptability(3-month post-enrolment visit, 6-month post-enrolment visit, 6-week postpartum visit)
- MMS Acceptability among Health Providers assessed by focus group discussions(6 months, 12 months)
- Fidelity of providing MMS among Health Providers as assessed by focus group discussions(3-months, 6-months, 9-months, and 12-months)