An interventional study of Optimized package of child essential health and nutrition services and Standard package of essential child and nutrition services in Coverage of Vitamin A Supplementation, Coverage of Immunization and Feasibility and Fidelity of Implementation, sponsored by Nutrition International. Recruiting at 2 sites in 2 countries. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Nutrition International · Not applicable, Interventional, and Health services research
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.
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.
Nutrition International is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The intervention arm receives the optimized package of child essential health and nutrition services
Other: Optimized package of child essential health and nutrition services
The control arm receives the current standard package of health and nutrition services
Other: Standard package of essential child and nutrition services
Optimized package of child essential health and nutrition services
Standard package of essential child and nutrition services
Children who received their age-appropriate VAS
The proportion of children 12-59 months of age who received their age-appropriate VAS
Time frame: From enrollment to the end of intervention at 12 months
Children who are immunized with measles vaccine
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
Time frame: From enrollment to the end of intervention at 12 months
Implementation feasibility of new model perceived by health service providers, as assessed by key informant interviews and focus groups
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
Time frame: From enrollment to the end of intervention at 12 months
Fidelity of implementing the new model
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%.
Time frame: From enrollment to the end of intervention at 12 months
Co-coverage of VAS and measles vaccine
Proportion of children 12-23 months of age who have received both their age-appropriate VAS and their age-appropriate vaccines (as measured by measles one) in Kenya Proportion of children 24-35 months of age who have received both their age-appropriate VAS and their age-appropriate vaccines (as measured by measles two) in Senegal
Time frame: From enrollment to the end of intervention at 12 months
Children screened for malnutrition in the last 6 months
The proportion of children 12-59 months of age who were screened for malnutrition in the last 6 months
Time frame: From enrollment to the end of intervention at 12 months
Children who have received growth monitoring service
The proportion of children 12-59 months who have received growth monitoring service
Time frame: From enrollment to the end of intervention at 12 months
Children who have received age-appropriate immunizations
The proportion of children 12-59 months who have received age-appropriate immunizations according to EPI schedule
Time frame: From enrollment to the end of intervention at 12 months
Caregivers who report receiving more than one service
The proportion of caregivers of children 12-59 months of age who reported ever receiving more than one of the following services within the Essential Child Health and Nutrition Package during the same visit
Time frame: From enrollment to the end of intervention at 12 months
Caregivers who indicate are satisfied with the way the services are being delivered
The proportion of caregivers indicate are satisfied with the way the Essential Child Health and Nutrition Package services are being delivered to their children
Time frame: From enrollment to the end of intervention at 12 months
Plan to share: No
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Started Feb 2025 (actual). Primary completion is estimated for Dec 2026, 22 months after the start.
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