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
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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RECRUITING
NA
1928 participants
INTERVENTIONAL
2025-02-21
2027-03-31
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention
The intervention arm receives the optimized package of child essential health and nutrition services
Optimized package of child essential health and nutrition services
Optimized package of child essential health and nutrition services
Control
The control arm receives the current standard package of health and nutrition services
Standard package of essential child and nutrition services
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
Standard package of essential child and nutrition services
Standard package of essential child and nutrition services
Eligibility Criteria
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Inclusion Criteria
* Health service providers
Exclusion Criteria
15 Years
ALL
Yes
Sponsors
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Kenya Ministry of Health
OTHER_GOV
Cheikh Anta Diop University, Senegal
OTHER
Senegal Ministry of Health
UNKNOWN
Henike Consultants
UNKNOWN
Nutrition International
OTHER
Responsible Party
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Daniel Lopez de Romana
Director Research, Innovation, and Evaluation
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
Nutrition International - Senegal
Dakar, , Senegal
Countries
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Central Contacts
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Facility Contacts
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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: 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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