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临床试验/NCT07400796
NCT07400796招募中不适用

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia: A Mixed-Methods Assessment

University of British Columbia1 个研究点 分布在 1 个国家目标入组 710 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
710
试验地点
1
主要终点
Perspectives on the transition to MMS

研究概览

简要总结

Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) to improve maternal and neonatal health outcomes. MMS likely provides additional antenatal benefits over IFA supplementation alone. The Cambodian government, in partnership with Helen Keller International, is piloting MMS implementation in Takeo Province, which will inform nationwide scale-up of MMS.

Study Purpose: The Takeo implementation must be evaluated to understand context-specific implementation of MMS and health system readiness for scale-up. This study assesses system readiness through four domains from the Intervention Scalability Assessment Tool (ISAT): (1) fidelity and adaptation, (2) reach and acceptability, (3) delivery setting and workforce capacity, and (4) implementation infrastructure.

Population: The pilot involves transitioning to MMS from IFA across all 86 health centers, all 6 referral hospitals, and the provincial hospital in Takeo province. This study includes pregnant women receiving antenatal care, antenatal healthcare providers and facilities, and hospital managers in Takeo. The study also includes national governing bodies for MMS delivery.

Methods: This mixed-methods study uses ISAT as a framework for developing data collection methods. Sampling strategies emphasize urban and rural representation across all operational districts in Takeo and diverse stakeholder perspectives at multiple levels of the health system. Data collection includes:

  • 12 focus group discussions (FGDs) with health center providers to assess provider adherence to MMS delivery guidelines, perspectives on the transition to MMS, and additional resources needed for MMS delivery
  • Workload assessment surveys at FGDs to quantify any burden on providers and resource gaps to deliver MMS
  • MMS stockout monitoring at 18 health centers and 7 hospitals to assess supply chain reliability
  • 15 key informant interviews with hospital managers to assess perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery
  • Phone surveys with 630 pregnant women to assess acceptability and adherence to MMS at 90- and 180-days after MMS distribution
  • One FGD with national-level stakeholders to assess national-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up
  • Rapid economic evaluation to estimate the cost of nationwide scale-up Potential Impact: This study will generate insights into real-world implementation of MMS in Cambodia. It will identify context-specific adaptations, implementation gaps, and resource planning frameworks needed for nationwide scale-up of MMS. Successful scale-up is anticipated to improve maternal and neonatal health in Cambodia. Findings can also be used to guide other LMICs seeking to transition to and sustainably implement MMS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For the cohort of pregnant individuals consuming MMS:
  • Inclusion Criteria:
  • Current pregnant
  • At least 18 years of age
  • Have attended at least one ANC visit at a health center or hospital in Takeo during the study period
  • Can provide a functioning phone number for follow-up contact
  • Willingness to participate and provide consent

排除标准

  • Individuals with diagnosed anemia who require iron and folic acid (IFA) supplementation instead of MMS
  • Individuals unable to communicate via telephone,;(3) individuals who withdraw consent at any point

研究组 & 干预措施

Focus group discussion (FGD) with national-level stakeholders in Cambodia

1 FGD with 5 national-level stakeholders in Cambodia

Focus group discussions (FGD) with health centre providers

15 FGD (5 individuals each)

Key informant interviews with hospital managers

17 hospital managers

Surveys with pregnant individuals who are consuming MMS

630 pregnant individuals consuming MMS

干预措施: Multiple micronutrient supplement (MMS) for pregnancy (Dietary Supplement)

结局指标

主要结局

Perspectives on the transition to MMS

时间窗: 4 months

12 FGD with health care providers

次要结局

  • Additional resources needed for successful MMS delivery(4 months)
  • Provider adherence to MMS delivery guidelines(4 months)
  • Adherence of pregnant individuals to MMS supplementation(6 months)
  • Perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery(4 months)
  • National-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up(4 months)
  • Quantification of any burden on providers and resource gaps to deliver MMS(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal Karakochuk

Associate Professor, Human Nutrition

University of British Columbia

研究点 (1)

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