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临床试验/NCT06949930
NCT06949930招募中不适用

OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS

Nutrition International2 个研究点 分布在 2 个国家目标入组 1,928 人开始时间: 2025年2月21日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,928
试验地点
2
主要终点
Children who received their age-appropriate VAS

研究概览

简要总结

The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A supplementation and the coverage of other child health and nutrition services. In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.

详细描述

Background: Countries have made significant progress over the last 20 years in improving child survival with under five mortality rates. Despite this progress, many countries still experience inequalities in the coverage of several essential child health and nutrition services, including vitamin A supplementation (VAS), growth monitoring and promotion (GMP), immunization, and regular nutrition screening for early detection of malnutrition. Optimizing the delivery of an Essential Child Health and Nutrition Package ("essential package") may address this issue.

Objective

The primary objective of the study is to assess the effect of optimizing the health system for the delivery of the essential package (the "implementation model"), on the coverage of VAS and on the coverage of immunization (as measured by vaccination for measles). In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.

Methods: Target population will be children 12-59 months of age and their caregivers in Kisii County in Kenya and Fatick Region in Senegal. The study will use an effectiveness-research implementation hybrid design with two arms: 1) health system will be optimized to deliver VAS to all children 12-59 months of age using all the routine primary health care (PHC) contact points plus current standard of care (Intervention) and 2) current standard of care (Control). The study will be conducted for a period of 18 months. The optimization model will be implemented for 12 months. Baseline and endline surveys that will collect quantitative and qualitative data will be conducted to assess the coverage of essential child health and nutrition services in both arms from study participants per arm in both baseline and endline surveys and to assess implementation feasibility. Implementation fidelity will be assessed through monthly visits by the research team to health facilities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caregivers of children 12-59 months of age
  • Health service providers

排除标准

  • 未提供

结局指标

主要结局

Children who received their age-appropriate VAS

时间窗: From enrollment to the end of intervention at 12 months

The proportion of children 12-59 months of age who received their age-appropriate VAS

Children who are immunized with measles vaccine

时间窗: From enrollment to the end of intervention at 12 months

Proportion of children 12-23 months of age who are immunized with one dose of measles (MR1) in Kenya Proportion of children 24-35 months of age who are immunized with the second dose of measles (MR2) in Senegal

Implementation feasibility of new model perceived by health service providers, as assessed by key informant interviews and focus groups

时间窗: From enrollment to the end of intervention at 12 months

Feasibility of implementation of the new model as perceived by health service providers will be assessed via key informant interviews and focus groups to enquire on: i. Implementation barriers and facilitators ii. Practicality of implementing the optimization model within context and resource availability iii. Program disruption due to the implementation of the model iv. Need for infrastructure to implement the model v. Sustainability of the optimized model. All qualitative information will be triangulated to assess feasibility of implementation of the new model

Fidelity of implementing the new model

时间窗: From enrollment to the end of intervention at 12 months

Fidelity of implementation will be assessed by measuring: i. The proportion of health facilities preparing and using integrated microplans. ii. The proportion of supportive supervision visits carried out in an integrated way. iii. The proportion of service delivery points providing services in an integrated way Fidelity will be achieved if the three parameters score at least 80%.

次要结局

  • Co-coverage of VAS and measles vaccine(From enrollment to the end of intervention at 12 months)
  • Children screened for malnutrition in the last 6 months(From enrollment to the end of intervention at 12 months)
  • Children who have received growth monitoring service(From enrollment to the end of intervention at 12 months)
  • Children who have received age-appropriate immunizations(From enrollment to the end of intervention at 12 months)
  • Caregivers who report receiving more than one service(From enrollment to the end of intervention at 12 months)
  • Caregivers who indicate are satisfied with the way the services are being delivered(From enrollment to the end of intervention at 12 months)

研究者

发起方
Nutrition International
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Lopez de Romana

Director Research, Innovation, and Evaluation

Nutrition International

研究点 (2)

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