NCT04834960

Brief Summary

Despite the overwhelming impact of vaccines on child health and the tremendous progress in vaccine coverage globally, challenges of vaccine inequities persist. Missed opportunities for vaccination (MOV) is defined as any contact with health services by an individual who is eligible for vaccination which does not result in the recommended vaccines being given. This is common in several countries, and it presents a window of opportunity to provide vaccine services to those vulnerable children accessing healthcare facilities. The overall purpose of this project is to reduce missed opportunities for vaccinations by targeting hospitalized children who are vulnerable to poor health outcomes, but who are also within easy access of the healthcare system. The research team proposes implementing the Missed Opportunities for Vaccination Equity (MOVE), an intervention to improve timeliness and coverage of vaccination, and increase demand for vaccination services, through a combination of sensitization of children's caregivers and health workers, manual vaccination data capture in the ward, and re-purposed vaccination resources. The strategy engages key stakeholders in the design of the intervention through a co-creation workshop; their involvement in the design and execution of the intervention will improve sustainability in the long-term. This intervention builds on existing healthcare systems, and, when scaled up, can target inequities in vaccination coverage in the general population, without placing additional strain on the healthcare system in terms of workforce or financial resources.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

April 5, 2021

Last Update Submit

October 5, 2022

Conditions

Keywords

vaccinationunder-vaccinationmissed opportunities for vaccination

Outcome Measures

Primary Outcomes (5)

  • Proportion of Children Fully Vaccinated Hospital Discharge

    The number fully vaccinated at admission + number given catch-up vaccination while in hospital, and up to the date at discharge / the number of all enrolled children. This outcome measures the desired outcome of full vaccination coverage among children who pass through in-patient health facilities. This is the main outcome of interest and will be compared in the pre-intervention and post-intervention phases.

    time of admission to discharge (about 1-2 weeks)

  • Partially Vaccinated or Un-vaccinated Children at Admission

    This is the proportion of those children who are under-vaccinated at hospital admission.

    time of admission to discharge (about 1-2 weeks)

  • Proportion of Under-Vaccinated children Deemed "Missed Opportunities of Vaccination"

    The number of eligible children who do not receive their due catch-up vaccines prior to hospital discharge / the number of children identified as under-vaccinated at hospital admission.

    time of admission to discharge (about 1-2 weeks)

  • Proportion of all Enrolled Children at Admission Given Vaccination Advice

    The number of all enrolled children at admission who get vaccination-related advice and/or referrals during the hospital stay / the number of all enrolled children participating in the study.

    time of admission to discharge (about 1-2 weeks)

  • Proportion of Incompletely Vaccinated Children Caught up After Discharge

    The number of incompletely vaccinated children at hospital discharge who get caught up on vaccinations within 1-4 weeks of hospital discharge / the number of children identified as under-vaccinated at hospital discharge.

    time of admission (about 1-2 weeks) to 1 month post discharge

Study Arms (1)

MOV Intervention

OTHER

Pre-intervention and post-intervention design

Other: Minimizing Missed Opportunities for Vaccination (MOV)

Interventions

This bundle of interventions has four components that include: (1) Disseminate (vaccination awareness among healthcare providers and child caregivers); (2) Document (vaccination status); (3) Deploy (vaccines); and (4) Discharge (provide advice/referrals for catch-up and routine vaccinations).

MOV Intervention

Eligibility Criteria

Age0 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages 0-23 months who are admitted into the emergency or inpatient unit of the hospital
  • Caregiver has access to the child's vaccination card or has direct knowledge of the child's vaccination history
  • Caregiver willing to provide informed consent for the study

You may not qualify if:

  • Health condition that precludes the use of vaccines such as a primary or secondary immune deficiency, such as HIV, malignancy requiring chemotherapy, or ongoing steroid therapy
  • Allergies or contraindications to any vaccine (or component thereof) in the national schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Post Graduate Institute of Medical Education and Research, India (PGIMER)

Chandigarh, India

Location

Aminu Kano Teaching Hospital

Kano, Kano State, Nigeria

Location

MeSH Terms

Interventions

Vaccination

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Anita Shet, MD, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a 'pre-post' study design, where the intervention is designed and implemented by the regular non-research clinical staff. This intervention has four components that are described in the 'intervention' section.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

September 24, 2020

Primary Completion

September 16, 2021

Study Completion

September 16, 2021

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations