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

NCT ID: NCT06949930

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1928 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

The intervention arm receives the optimized package of child essential health and nutrition services

Group Type EXPERIMENTAL

Optimized package of child essential health and nutrition services

Intervention Type OTHER

Optimized package of child essential health and nutrition services

Control

The control arm receives the current standard package of health and nutrition services

Group Type OTHER

Standard package of essential child and nutrition services

Intervention Type OTHER

Standard package of essential child and nutrition services

Interventions

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Optimized package of child essential health and nutrition services

Optimized package of child essential health and nutrition services

Intervention Type OTHER

Standard package of essential child and nutrition services

Standard package of essential child and nutrition services

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kenya Ministry of Health

OTHER_GOV

Sponsor Role collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role collaborator

Senegal Ministry of Health

UNKNOWN

Sponsor Role collaborator

Henike Consultants

UNKNOWN

Sponsor Role collaborator

Nutrition International

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lopez de Romana

Director Research, Innovation, and Evaluation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mandana Arabi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nutrition International

Elijah Mbiti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nutrition International

Locations

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Nutrition International- Kenya

Nairobi, , Kenya

Site Status RECRUITING

Nutrition International - Senegal

Dakar, , Senegal

Site Status RECRUITING

Countries

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Kenya Senegal

Central Contacts

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Daniel Lopez de Romana, Ph.D.

Role: CONTACT

613-782-6837

Banda Ndiaye, B.S.

Role: CONTACT

+254780457298

Facility Contacts

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Elijah Mbiti, Ph.D.

Role: primary

+254709688000

Enock Matoke Makori

Role: backup

+254709688000

Elijah Mbiti, Ph.D.

Role: backup

Daniel Lopez de Romana, Ph.D.

Role: backup

Banda Ndiaye, DrPh

Role: backup

Mandana Arabi, M.D., Ph.D.

Role: backup

Alison Greig

Role: backup

Caitlin Gomez, M.S.

Role: backup

Francis Ngure, Ph.D.

Role: backup

Taylor Morrison, M.S.

Role: backup

Geoffrey Kinyua

Role: backup

Richard Onkware

Role: backup

Samuel Onguso

Role: backup

Banda Ndiaye

Role: primary

+254780457298

Marcel Yanga

Role: backup

+221338693002

Banda Ndiaye

Role: backup

Mandana Arabi, M.D., Ph.D.

Role: backup

Daniel Lopez de Romana

Role: backup

Alison Greig

Role: backup

Caitlin Gomez, M.S.

Role: backup

Francis Ngure, Ph.D.

Role: backup

Taylor Morrison, M.S.

Role: backup

Marcel Yanga

Role: backup

Balla Moussa Diedhiou

Role: backup

Mamadou Diop

Role: backup

Papa Birane Mbodji

Role: backup

Assane Ndiaye

Role: backup

Mbacke Sylla

Role: backup

Other Identifiers

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Nutrition International

Identifier Type: -

Identifier Source: org_study_id

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