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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06949930
Enrollment
1928
Registered
2025-04-29
Start date
2025-02-21
Completion date
2027-03-31
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coverage of Immunization, Coverage of Vitamin A Supplementation, Feasibility and Fidelity of Implementation

Keywords

VAS, immunization, coverage, hybrid effectiveness-implementation research study, essential child health and nutrition services

Brief summary

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.

Detailed description

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.

Interventions

OTHEROptimized package of child essential health and nutrition services

Optimized package of child essential health and nutrition services

OTHERStandard package of essential child and nutrition services

Standard package of essential child and nutrition services

Sponsors

Kenya Ministry of Health
CollaboratorOTHER_GOV
Cheikh Anta Diop University, Senegal
CollaboratorOTHER
Senegal Ministry of Health
CollaboratorUNKNOWN
Henike Consultants
CollaboratorUNKNOWN
Nutrition International
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Implementation model aims to optimize health workforce training and supervision, service delivery, health data and information, and leadership and governance as so to maximize VAS coverage and in doing so also improve coverage of other services

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Children who received their age-appropriate VASFrom enrollment to the end of intervention at 12 monthsThe proportion of children 12-59 months of age who received their age-appropriate VAS
Children who are immunized with measles vaccineFrom enrollment to the end of intervention at 12 monthsProportion 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 groupsFrom enrollment to the end of intervention at 12 monthsFeasibility 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 modelFrom enrollment to the end of intervention at 12 monthsFidelity 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%.

Secondary

MeasureTime frameDescription
Caregivers who report receiving more than one serviceFrom enrollment to the end of intervention at 12 monthsThe 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
Co-coverage of VAS and measles vaccineFrom enrollment to the end of intervention at 12 monthsProportion 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
Caregivers who indicate are satisfied with the way the services are being deliveredFrom enrollment to the end of intervention at 12 monthsThe proportion of caregivers indicate are satisfied with the way the Essential Child Health and Nutrition Package services are being delivered to their children
Children screened for malnutrition in the last 6 monthsFrom enrollment to the end of intervention at 12 monthsThe proportion of children 12-59 months of age who were screened for malnutrition in the last 6 months
Children who have received growth monitoring serviceFrom enrollment to the end of intervention at 12 monthsThe proportion of children 12-59 months who have received growth monitoring service
Children who have received age-appropriate immunizationsFrom enrollment to the end of intervention at 12 monthsThe proportion of children 12-59 months who have received age-appropriate immunizations according to EPI schedule

Countries

Kenya, Senegal

Contacts

Primary ContactDaniel Lopez de Romana, Ph.D.
dlopezderomana@nutritionintl.org613-782-6837
Backup ContactBanda Ndiaye, B.S.
bndiaye@nutritionintl.org+254780457298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026