Clinical trial NCT06949930: OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
Official title: OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coverage of Vitamin A Supplementation
Coverage of Immunization
Feasibility and Fidelity of Implementation
Keywords: VAS
immunization
coverage
hybrid effectiveness-implementation research study
essential child health and nutrition services
Lead sponsor: Nutrition International
Sponsor class: OTHER
Collaborators: name: Kenya Ministry of Health
name: Cheikh Anta Diop University, Senegal
name: Senegal Ministry of Health
name: Henike Consultants
First posted: 2025-04-29
Enrollment: 1928
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: Children who received their age-appropriate VAS
timeFrame: From enrollment to the end of intervention at 12 months
measure: Children who are immunized with measles vaccine
timeFrame: From enrollment to the end of intervention at 12 months
measure: Implementation feasibility of new model perceived by health service providers, as assessed by key informant interviews and focus groups
timeFrame: From enrollment to the end of intervention at 12 months
measure: Fidelity of implementing the new model
timeFrame: From enrollment to the end of intervention at 12 months
Secondary outcomes:
measure: Co-coverage of VAS and measles vaccine
timeFrame: From enrollment to the end of intervention at 12 months
measure: Children screened for malnutrition in the last 6 months
timeFrame: From enrollment to the end of intervention at 12 months
measure: Children who have received growth monitoring service
timeFrame: From enrollment to the end of intervention at 12 months
measure: Children who have received age-appropriate immunizations
timeFrame: From enrollment to the end of intervention at 12 months
measure: Caregivers who report receiving more than one service
timeFrame: From enrollment to the end of intervention at 12 months
measure: Caregivers who indicate are satisfied with the way the services are being delivered
timeFrame: From enrollment to the end of intervention at 12 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Nutrition International- Kenya
city: Dakar
country: Senegal
facility: Nutrition International - Senegal
Study officials:
affiliation: Nutrition International
name: Mandana Arabi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrition International
name: Elijah Mbiti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: