NCT06698497

Brief Summary

Vaccinations are among the most successful and critical public health interventions. Despite the enormous protection that vaccines provide to public health, both delays and refusals of vaccines (vaccine hesitancy) are on the rise. Given that low vaccination rates present both an individual and community risk, it is critical that measures are taken to increase vaccination uptake in both rural and urban counties in New York. Wastewater surveillance of SARS-CoV-2 has been shown to be a leading indicator of pending surges. This study will examine whether a communications campaign based upon SARS-CoV-2 wastewater surveillance data can increase COVID-19 vaccine uptake. Forty counties have been selected for the communication campaign (20 in the treatment group and 20 in the control group). A difference-in-differences method will be applied to assess the impact of the communications campaign on vaccine uptake, which observes the outcomes between a control and treatment group over pre- and post-intervention time periods. The communications campaign will be evaluated using the change in vaccination status of residents of the treatment and control counties. Outcomes will also be compared between demographic groups including race and ethnicity because of differences in vaccination rates that have been already observed. We hypothesize that information regarding COVID-19 provided by wastewater surveillance that is geographically based and more local to communities will increase COVID-19 vaccine uptake. This theory of local information having an impact on health behavior is a novel application of the health belief model to increase vaccine uptake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 13, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

November 8, 2024

Last Update Submit

September 12, 2025

Conditions

Keywords

COVID-19 vaccinewastewater surveillancevaccine campaigncommunication campaignvaccine uptakevaccine hesitancyhealth belief modelCOVID-19SARS-CoV-2coronavirus

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Vaccine Uptake

    The change in vaccination coverage among residents of the counties in the study will be measured as the percent of the population that received a vaccine dose.

    11 weeks

Study Arms (2)

Communications Intervention Group

EXPERIMENTAL
Behavioral: Communication Campaign

Control

NO INTERVENTION

Interventions

A social media vaccine communications campaign is deployed once increasing amounts of SARS-CoV-2 RNA are identified in the New York State wastewater surveillance network. The social media campaigns on Facebook, Instagram, and NextDoor social media platforms will run for 11 weeks. The campaign disseminates information about the wastewater surveillance network and vaccination (not COVID-19 specific) to residents in intervention counties. These social media platforms not only allow for quick and cost-effective exposure, but also allow for participation and interaction with participants. The campaign ads include a call-to-action link to the New York State wastewater surveillance network webpage which has information and links regarding vaccines for respiratory transmitted pathogens (COVID-19, influenza, and RSV) and how to schedule an appointment.

Communications Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Counties in New York State

You may not qualify if:

  • Counties outside of New York State

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13057, United States

Location

MeSH Terms

Conditions

Vaccination HesitancyCOVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 21, 2024

Study Start

September 13, 2024

Primary Completion

November 24, 2024

Study Completion

July 10, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations