NCT06949930

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,928

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Feb 2025Mar 2027

Study Start

First participant enrolled

February 21, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

April 14, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

VASimmunizationcoveragehybrid effectiveness-implementation research studyessential child health and nutrition services

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Co-coverage of VAS and measles vaccine

    From enrollment to the end of intervention at 12 months

  • Children 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

    From enrollment to the end of intervention at 12 months

  • Children who have received age-appropriate immunizations

    From enrollment to the end of intervention at 12 months

  • Caregivers who report receiving more than one service

    From enrollment to the end of intervention at 12 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Optimized package of child essential health and nutrition services

Control

OTHER

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

Other: Standard package of essential child and nutrition services

Interventions

Optimized package of child essential health and nutrition services

Intervention

Standard package of essential child and nutrition services

Control

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nutrition International- Kenya

Nairobi, Kenya

RECRUITING

Nutrition International - Senegal

Dakar, Senegal

RECRUITING

MeSH Terms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mandana Arabi, M.D., Ph.D.

    Nutrition International

    PRINCIPAL INVESTIGATOR
  • Elijah Mbiti, Ph.D.

    Nutrition International

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lopez de Romana, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Research, Innovation, and Evaluation

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 29, 2025

Study Start

February 21, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations