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

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.

Study Overview

• Status: Recruiting
• Conditions: Coverage of Vitamin A Supplementation; Coverage of Immunization; Feasibility and Fidelity of Implementation
• Intervention / Treatment: Other: Optimized package of child essential health and nutrition services; Other: Standard package of essential child and nutrition services

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.

• Study Type: Interventional
• Enrollment (Estimated): 1928
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lopez de Romana, Ph.D.; Phone Number: 613-782-6837; Email: dlopezderomana@nutritionintl.org
• Study Contact Backup: Name: Banda Ndiaye, B.S.; Phone Number: +254780457298; Email: bndiaye@nutritionintl.org

Study Locations

• Kenya
  • Nairobi, Kenya
    • Recruiting
    • Nutrition International- Kenya
    • Contact: Elijah Mbiti, Ph.D.; Phone Number: +254709688000; Email: embiti@nutritionintl.org
    • Contact: Enock Matoke Makori; Phone Number: +254709688000; Email: emakori@nutritionintl.org
    • Contact: Elijah Mbiti, Ph.D.
    • Contact: Daniel Lopez de Romana, Ph.D.
    • Contact: Banda Ndiaye, DrPh
    • Contact: Mandana Arabi, M.D., Ph.D.
    • Contact: Alison Greig
    • Contact: Caitlin Gomez, M.S.
    • Contact: Francis Ngure, Ph.D.
    • Contact: Taylor Morrison, M.S.
    • Contact: Geoffrey Kinyua
    • Contact: Richard Onkware
    • Contact: Samuel Onguso
• Senegal
  • Dakar, Senegal
    • Recruiting
    • Nutrition International - Senegal
    • Contact: Mandana Arabi, M.D., Ph.D.
    • Contact: Alison Greig
    • Contact: Caitlin Gomez, M.S.
    • Contact: Francis Ngure, Ph.D.
    • Contact: Taylor Morrison, M.S.
    • Contact: Banda Ndiaye; Phone Number: +254780457298; Email: bndiaye@nutritionintl.org
    • Contact: Marcel Yanga; Phone Number: +221338693002; Email: marcelyanga87@gmail.com
    • Contact: Banda Ndiaye
    • Contact: Daniel Lopez de Romana
    • Contact: Marcel Yanga
    • Contact: Balla Moussa Diedhiou
    • Contact: Mamadou Diop
    • Contact: Papa Birane Mbodji
    • Contact: Assane Ndiaye
    • Contact: Mbacke Sylla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention arm receives the optimized package of child essential health and nutrition services	Other: Optimized package of child essential health and nutrition services; Optimized package of child essential health and nutrition services
Other: Control; The control arm receives the current standard package of health and nutrition services	Other: Standard package of essential child and nutrition services; Standard package of essential child and nutrition services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children who received their age-appropriate VAS	The proportion of children 12-59 months of age who received their age-appropriate VAS	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	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	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%.	From enrollment to the end of intervention at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	From enrollment to the end of intervention at 12 months

Collaborators and Investigators

• Sponsor: Nutrition International
• Collaborators: Cheikh Anta Diop University, Senegal; Kenya Ministry of Health; Senegal Ministry of Health; Henike Consultants
• Investigators: Principal Investigator: Mandana Arabi, M.D., Ph.D., Nutrition International; Principal Investigator: Elijah Mbiti, Ph.D., Nutrition International

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: VAS; immunization; coverage; hybrid effectiveness-implementation research study; essential child health and nutrition services
• Other Study ID Numbers: Nutrition International

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No