Utilizing Wastewater Surveillance Data in a Communications Campaign to Boost Vaccination Uptake in New York State: a Comparison-control Trial
Phase: NA
Conditions: Vaccination, Wastewater Surveillance
Sponsor: Syracuse University

Protocol 
 
Version: January 2023 
 
 
1 
 
 
 
Boosting vaccination uptake using wastewater 
surveillance: a comparison-control trial 
 
 
Utilizing wastewater surveillance data in a communications campaign as a 
driver behind COVID-19 vaccine uptake in New York State 
 
 
 

Protocol 
 
Version: January 2023 
 
 
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INVESTIGATORS 
 
Principal Investigator 
David A. Larsen, PhD MPH 
Syracuse University  
344D White Hall 
Syracuse, NY 13244 
Phone: +1 315-399-2636 
Email: dalarsen@syr.edu 
 
 
Co- investigators 
 
Lydia J. Bennett, MPH 
Center for Environmental Health, New 
York State Department of Health 
CDC Foundation 
Email: lbennett@cdcfoundation.org  
 
Dustin T. Hill, PhD 
Department of Public Health,  
Syracuse University 
Email: dthill@syr.edu  
 
Milagros Neyra, MPH 
Department of Public Health,  
Syracuse University 
Email: mineyra@syr.edu 
 
Dana Neigel, MPH 
Center for Environmental Health, New 
York State Department of Health 
CDC Foundation 
Email: dneigel@cdcfoundation.org  
 
Nicole Pulido 
Syracuse University 
Department of Public Health 
Email: npulido@syr.edu 
 
Shailla J. Raymond, MPH 
Center for Environmental Health, New 
York State Department of Health 
CDC Foundation 
Email: sraymond@cdcfoundation.org  
 
Nan Yang 
Syracuse University 
Department of Public Health 
Email: nyang03@syr.edu 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATORS 
2 
PROJECT SUMMARY 
4 
RATIONALE AND BACKGROUND 
5 
Objectives 
6 
TARGET COUNTIES 
7 
INTERVENTION 
7 
EVALUATION 
7 
Study Design 
7 
Selection of control and treatment counties 
7 
Outcomes 
8 
Data to be collected 
9 
Statistical analyses 
9 
TIMEFRAME 
10 
HUMAN SUBJECTS RESEARCH 
10 
Risks to subjects 
10 
Adequacy of protection against risks 
10 
Potential benefits of the proposed research to the subjects and others 
10 
Data and safety monitoring plan 
10 
Inclusion of women and minorities 
11 
Inclusion of children 
11 
Trial Registration 
11 
Protocol Accessibility 
11 
Funding Stream 
11 
Conflict of Interest Statement 
12 
Ethical approval 
12 
APPENDICES 
12 
Appendix 1 – Letter of Cooperation from New York State Department of Health 
12 
Appendix 2 – Letter of Cooperation from Local Health Departments 
12 
REFERENCES 
12 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROJECT SUMMARY 
 
Goal 
To determine the effect of a communications campaign sharing wastewater 
surveillance data to influence vaccine uptake in a metropolitan and non-
metropolitan environment. 
Intervention 
site 
Onondaga and Cayuga counties in New York State 
Populations 
Individuals of all ages within the selected counties, located in metropolitan 
and non-metropolitan environments.  
Evaluation 
study design 
Comparison-control trial 
Primary 
outcome 
measures 
Proportion of vaccine-eligible individuals in the county that received the 
COVID-19 vaccine stratified by type of vaccine dosage and age group 
Data collection 
and sampling 
method 
Vaccination data will be aggregated to the county by the State Department 
of Health and shared with the research team.  
Wastewater data will be pulled from the wastewater surveillance network. 
Statistical and 
analytic plan 
A difference in differences analysis will be used to estimate the effect of 
the intervention on both the outcomes between intervention and 
comparison groups following the intervention, while adjusting for potential 
confounding factors.  
 
 

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RATIONALE AND BACKGROUND 
 
Vaccinations are among the most successful and critical public health interventions. The 
expanded program for immunizations is responsible for preventing an estimated 4-5 
million deaths globally, and capable of preventing an additional 1.5 million deaths with 
universal global coverage.1,2 Despite the enormous protection that vaccines provide to 
public health, delays and refusals of vaccines (vaccine hesitancy) are on the rise.3,4 
Vaccine hesitancy leads to lower community-level vaccination rates which threaten 
resurgences of vaccine-preventable diseases such as polio or measles and increase the 
severity of seasonal infectious diseases such as influenza.5,6 The drivers of vaccine 
hesitancy are complex, and can vary heavily between different demographic groups. 
Reasons for vaccine hesitancy tend to fit into three categories: 1) a lack of confidence in 
effectiveness, safety, system, or policy makers; 2) a perceived lower risk of acquiring a 
vaccine preventable disease; and 3) a lack of availability, accessibility, and convenience 
in obtaining a vaccine.7,8 
 
Vaccines are now (as of 2023) the primary prevention intervention for the COVID-19 
pandemic in the United States. As of September 2022, 83.4% of New Yorkers statewide 
have received at least one vaccination dose for COVID-19, and 75.4% have received a 
completed vaccine series (completed COVID-19 vaccine series and booster).9 These 
percentages vary based on demographics such as race, ethnicity, age, and gender.10 Rural 
and urban communities also vary greatly when it comes to COVID-19 vaccination 
coverage, with rural counties having lower vaccination rates than urban counties across 
the United States.11 This disparity is present in New York counties as well, with rural 
counties having lower COVID-19 vaccination uptake (first dose, boosters, completed 
series) than urban counties.9 There are various factors that could contribute to the 
vaccination coverage disparities between urban and rural counties. Accessibility to 
healthcare services continues to be a challenge in rural regions, such as a lack of 
healthcare providers and minimal information on how and where to seek out services.12,13 
 
Given that low vaccination rates present both an individual and community risk, it is 
critical that public health departments take measures to increase vaccination uptake 
across New York State. Vaccination communication and education have the potential to 
change how individuals feel about vaccinations, clarify common and widespread 
misconceptions, and address vaccine hesitancy in the process. 8,12  The success of public 
health campaigns can vary depending on interactions between the message, material, and 
target communities of the campaign. 17,18 Therefore, it’s important to create an effective 
communication plan that not only spreads the message of pro-vaccinations, but also 
caters to the communities that are involved.  Vaccine uptake interventions and campaigns 
often use the health belief model in identifying levers that might motivate individuals to 
get vaccinated. We hypothesize that infectious disease surveillance data, specifically 
wastewater surveillance data, can act on the perceived susceptibility of vaccine-hesitant 
individuals in the health belief model (Figure 1). 
 
 

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Figure 1: The health belief model as it relates to our hypothesis of using infectious disease 
surveillance to increase the perceived susceptibility of an individual to COVID-19. 
 
Wastewater surveillance of SARS-CoV-2 has been shown to be a leading indicator of 
pending surges. Our work in New York State shows that the variability in wastewater 
data precedes surges in COVID-19 cases by about four weeks (Moran et al. in 
preparation). This study will examine whether a communications campaign based upon 
SARS-CoV-2 wastewater surveillance data with a 4-week lead time to surges can 
increase COVID-19 vaccine uptake. 
 
 
Objectives 
 
The goal of this trial is to test the effect of a communications campaign based upon 
wastewater surveillance data on COVID-19 vaccine uptake.  
 
This protocol presents a plan for conducting a strategic communications campaign to 
identify the impact of sharing public health messaging based upon wastewater 
surveillance data on COVID-19 vaccination uptake. The specific objectives of this 
project are to: 
1. Assess the impact of a communications campaign on the outcomes of COVID-19 
vaccine uptake, including initial dose, complete series, booster dose, and bivalent 
booster dose by age group, following implementation of the communications 
campaign in selected metropolitan and non-metropolitan counties. 
2. Strengthen the capacity of the New York State Department of Health and local 
health departments in determining how to apply their resources to disseminate 
wastewater surveillance data effectively with the general population. 

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INTERVENTION COUNTIES  
 
The comparison control trial to assess a communications campaign using wastewater 
surveillance data will be conducted in Onondaga County (metropolitan) and neighboring 
Cayuga County (non-metropolitan) in New York State. Monroe and Seneca Counties will 
serve as a comparison to Onondaga and Cayuga Counties, respectively. These counties 
were selected based on similarities across population density, demographics (age, sex, 
race, ethnicity), wastewater surveillance population coverage, and vaccination rates. 
 
INTERVENTION 
 
In intervention communities we will deploy a COVID-19 vaccine communications 
campaign based upon the increasing variability in the amounts of SARS-CoV-2 RNA 
found in wastewater. (Increasing variability in the amounts of SARS-CoV-2 RNA in 
wastewater acts as a 4-week leading indicator, Moran et al. in preparation). Through the 
New York State Wastewater Surveillance Network, wastewater samples are analyzed to 
determine whether COVID-19 trends are increasing or decreasing in the community. This 
information is then shared with county health officials to better improve understanding of 
the underlying COVID-19 transmission risk.  
 
Social media will be used to disseminate wastewater surveillance data and vaccination 
information to residents in Onondaga and Cayuga Counties. Social media platforms will 
not only allow for quick and cost-effective exposure, but also will allow for participation 
and interaction with participants. In addition, local health departments will be engaged to 
enhance their press releases and public health advisories to their communities.   
 
EVALUATION 
 
Study Design 
 
We will use a difference-in-differences (DiD) method to assess the impact of the 
communications campaign on vaccine uptake. The DiD method observes the outcomes 
between a control and intervention group over pre- and post-intervention time periods.  
 
Selection of control and treatment counties 
 
The counties were selected based on the following criteria: 
1. Population density: metropolitan vs. non-metropolitan area 
2. Demographics (age, sex, race, ethnicity) 
3. Wastewater surveillance coverage: population served and sampling frequency 
4. COVID-19 vaccination rates 
 
The U.S. Office of Management and Budget defines Monroe and Onondaga as 
metropolitan counties with an urban core of 50,000 or more people, while Seneca and 

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Cayuga are defined as non-metropolitan counties an urban core of 10,000-49,999 people 
or as being outside of metro areas. The metropolitan and non-metropolitan counties also 
shared similar demographics, wastewater surveillance coverage, COVID-19 vaccination 
rate.  
 
COVID-19 vaccine coverage across the included counties is presented in Table 1. Table 1 
also provides other county-level metrics that might be associated with vaccine uptake 
including the social vulnerability index, population density, number of corner-store 
pharmacies that serve as vaccine providers, and average income. 
 
Table 1: County-level metrics with possible association with vaccine uptake. 
 
 
Metropolitan 
Counties 
Non-Metropolitan 
Counties 
 
 
Monroe 
Onondaga 
Seneca 
Cayuga 
COVID-19 vaccine 
coverage 
Primary Series 
74.0 
74.0 
53.9 
60.8 
 
Up to Date 
17.3 
15.9 
11.4 
12.0 
Social vulnerability 
index 
Socioeconomic 
Status 
0.4426 
0.4918 
0.4918 
 
0.6066 
 
Household 
Characteristic 
0.8525 
0.7377 
0.5738 
 
0.3443 
 
Racial & Ethnic 
Minority Status 
0.8361 
0.7377 
0.4754 
0.4262 
 
Housing Type & 
Transportation 
0.4754 
0.7541 
0.4098 
0.7213 
Pharmacies 
per 10,000 People 
1.87 
2.21 
1.46 
2.08 
Population 
Number 
743084 
461591 
34016 
76958 
 
Density per sq mile 
1125.1 
590.2 
105.81 
110.47 
Income 
Median Household 
Income ($) 
65,957 
65,541 
54,865 
63,511 
Vaccination data as of 11/18/22 from: https://coronavirus.health.ny.gov/vaccination-progress-date  
People with primary series represents the total number of individuals who have completed the recommended initial series of a 
given COVID-19 vaccine product (e.g., 2 doses of the 2-dose Pfizer or Moderna vaccine; 1 dose of the single dose Johnson & 
Johnson vaccine). 
People up to date represents the total number of individuals who have completed all COVID-19 vaccinations, including the 
bivalent booster, as appropriate per age and clinical recommendations (CDC At-A-Glance COVID-19 Vaccination Schedules). 
Social Vulnerability Index from: https://www.atsdr.cdc.gov/placeandhealth/svi/interactive_map.html 
Theme rankings: For each of the four themes, we summed the percentiles for the variables comprising each theme. We ordered the 
summed percentiles for each theme to determine theme-specific percentile rankings. 
Population 2020 Estimates 
 
 
Outcomes  
 
The communications campaign will be evaluated using the change in vaccination status 
of residents of the treatment and control counties. Change in vaccination status will be 

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broken down by type of vaccine dose (e.g., initial series v. booster dose) and age because 
vaccine eligibility varies by age group (Table 2).19  
 
Table 2: Proposed age and vaccine dose breakdown for vaccination outcomes. 
Age group 
Primary Series 
Up to Date with bivalent booster 
18+ 
85.2 
12.3 
12-17 
73.1 
4.2 
5-11 
39.6 
1.9 
Under 5 
6.2 
-- 
Notes: People with primary series represents the total number of individuals who have 
completed the recommended series of a given COVID-19 vaccine product (e.g., 2 doses of the 
2-dose Pfizer or Moderna vaccine; 1 dose of the single dose Johnson & Johnson vaccine).  
People up to date represents the total number of individuals who have followed and completed 
the all COVID-19 vaccinations, including the bivalent booster, as appropriate per age and 
clinical recommendations (CDC At-A-Glance COVID-19 Vaccination Schedules). 
Vaccination progress tracking in New York was updated 11/30/22 to reflect the most current 
ACIP recommendations. 
Data from https://coronavirus.health.ny.gov/demographic-vaccination-data  
 
 
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. Outcomes will 
also be compared between demographic groups including race and ethnicity because of 
differences in vaccination rates that have been already observed.20   
 
Data to be collected 
All data used in this study is routinely gathered and disseminated by the New York State 
Department of Health. No individual human data will be collected as part of the study. 
 
 Statistical analyses 
 
We will use a difference-in-differences (DiD) method to evaluate the effectiveness of the 
communications campaign using the following equation: 
 
𝐷𝑖𝐷= 𝐸(𝑌!
" − 𝑌#
"|𝑇! = 1) −𝐸(𝑌!
$ −𝑌#
$|𝑇! = 0) 
 
The DiD is calculated from the differences between the treatment group (𝑇! = 1) and the 
control group (𝑇! = 0) from their initial condition at t = 0 or time zero. The change in 
each group is compared to determine if the intervention resulted in different outcome in 
the treatment group. In our study, the outcome is the percent of the county populations 
that received COVID-19 vaccines during the study period and whether the treatment 
counties had greater vaccination rates by the end of the study than the control counties. 
We will determine the statistical significance for DiD using a regression framework 
where the mean vaccination rate (Y) is predicted by whether the county received the 
treatment (the communications campaign) or not. The mean will be determined for the 
total vaccination rate as well as each of the age categories identified in Table 2.  

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TIMEFRAME 
 
Table 3: Time frame for proposed activities 
Project Years: 
2022 
2023 
 
Q1 Q2 
Q3 Q4 
Q1 Q2 
Q3 
Q4 
Finalization of Communication Campaign Intervention 
 
 
 
 
 
 
 
 
Baseline Measures 
 
 
 
 
 
 
 
 
Communications Campaign 
 
 
 
 
 
 
 
 
Endline Measures 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
Dissemination of results 
 
 
 
 
 
 
 
 
 
 
 
HUMAN SUBJECTS RESEARCH 
 
Risks to subjects 
 
No reasonably foreseeable risks, discomforts, hazards, or inconveniences are anticipated 
in relation to the communications campaign. All data used will be non-human data 
(aggregated County vaccine coverage for example).  
 
Adequacy of protection against risks 
 
We are requesting a waiver of informed consent for this project. Since we are using 
existing clinical testing and wastewater surveillance data, this study could not be 
practically carried out without a waiver of informed consent. A letter of cooperation 
signed by the local health departments overlooking the selected sewersheds/counties 
involved in this research will be provided.   
 
Potential benefits of the proposed research to the subjects and others 
 
Populations in the selected counties may expect increased vaccination rates, leading to 
herd immunity against SARS-CoV-2. Additionally, increased education and knowledge 
on the correlation between communications and vaccination rates will be made available.  
 
Data and safety monitoring plan 
 
We are continuing to collect wastewater surveillance data from the selected sewersheds 
for analysis and updating the New York State Wastewater Surveillance Network 
platform. At no point will any individual within the scope of surveillance be identified or 
exposed to any potential harm. Data monitoring to evaluate risks or harm to participants 

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will not be needed for this project. All data used in this study are de-identified and 
aggregated to county level. 
 
Inclusion of women and minorities 
 
We anticipate that half of the research subjects will be women, given the demographic 
composition of the population. Our study will be conducted in two non-metropolitan 
counties (Seneca and Cayuga) and two metropolitan counties (Onondaga and Monroe), 
where the racial and ethnic profile of the communities is homogenous. We do not expect 
to find significant race/ethnicity differences in the intervention effect. 
 
Inclusion of children 
 
Children are not a major focus of this research, but we do expect children between the 
ages of 1 month and 5 years of age to fall within the scope of the areas being considered 
for this study. 
 
Trial Registration 
 
To ensure external review of the protocol and to allow easy access for entry into 
subsequent systematic reviews, this trial will be registered with ClinicalTrials.gov prior 
to distribution of any communications materials. This is in accordance with the WHO 
statement that “The registration of all interventional trials is a scientific, ethical and moral 
responsibility” (http://www.who.int/ictrp/en/).  
 
Protocol Accessibility 
 
The complete protocol will be submitted to a peer-reviewed journal ahead of intervention 
delivery in the study site. This will prevent the likelihood of undeclared post-hoc changes 
to the protocol following IRB submission and of selective outcome reporting when the 
trial results are published. Additionally, this will provide peers and relevant partners 
working in the arena of wastewater surveillance and public health communications, 
advanced warning of a trial being planned for and provide opportunity not to duplicate 
similar intervention studies where the outcomes of this trial may hold external validity for 
their given wastewater-based epidemiology setting.  
 
Funding Stream 
 
The evaluation will be funded through the CDC Epidemiology and Laboratory Capacity 
program via funding awarded to NYSDOH. The funders will have a significant role in 
the study design. However, the funders will have no role in the data collection and 
analysis, decision to publish or preparation of the manuscript for protocol publication and 
trial outcome research article. 
 

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Conflict of Interest Statement 
 
The Principal and Co-investigators along with other personnel involved with the 
implementation of this trial are not affiliated or employed by the funding organization. 
Additionally, none of the associated individuals are employed, affiliated or hold stocks or 
shares in the organizations, that through a competitive bidding tender process, will 
provide wastewater analysis, or vaccination data related to the primary outcomes in the 
trial. 
 
Ethical approval 
 
The trial will be submitted for ethical approval to the IRB at Syracuse University (USA) 
and the New York State Department of Health. 
 
APPENDICES 
 
Appendix 1 – Letter of Cooperation from New York State Department of 
Health 
 
Appendix 2 – Letters of Cooperation from Local Health Departments 
 
 
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