NCT04936776

Brief Summary

As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

February 9, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

March 5, 2021

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person)

    Baseline - 1 year

Secondary Outcomes (1)

  • Number of scheduled appointments

    1 year

Study Arms (3)

Text message 1

Text messaging frame = safety and cleanness of clinic site. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network.

Behavioral: Text messaging

Text message 2

Text messaging frame = importance of vaccines. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network.

Behavioral: Text messaging

No text message

No text sent.

Interventions

Text messagingBEHAVIORAL

Text parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates.

Text message 1Text message 2

Eligibility Criteria

Age1 Year - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.

You may qualify if:

  • Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.

You may not qualify if:

  • Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Holly Krelle

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

June 23, 2021

Study Start

February 9, 2021

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations