Communication Campaign for COVID-19 Vaccine Uptake

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Syracuse University

Disqualifiers: Outside New York, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Communication Campaign for increasing COVID-19 vaccine uptake?

Research shows that communication strategies, like outreach messages, can effectively increase vaccine rates, as seen in a study where text and phone messages improved COVID-19 vaccine uptake among adolescents. ^{1 2 3 4 5}

Is the COVID-19 vaccine safe for humans?

Research shows that COVID-19 vaccines are generally safe for humans, with most side effects being mild to moderate, such as local pain or mild fever. Some studies noted rare severe reactions, but these are uncommon, and the vaccines have been deemed safe for widespread use. ^{6 7 8 9 10}

How does the Communication Campaign treatment for COVID-19 vaccine uptake differ from other treatments?

The Communication Campaign treatment is unique because it focuses on using public health communications to encourage people to get vaccinated, rather than directly administering a vaccine or medication. This approach aims to increase vaccine uptake by building confidence and understanding through information and engagement, which is different from traditional medical treatments that involve physical interventions. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for residents of selected rural and urban counties in New York. It aims to understand if local COVID-19 data shared through a communication campaign can encourage more people to get vaccinated.

Inclusion Criteria

Counties in New York State

Exclusion Criteria

Counties outside of New York State

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a communications campaign based on SARS-CoV-2 wastewater surveillance data to increase COVID-19 vaccine uptake

11 weeks

Follow-up

Participants are monitored for changes in vaccination status and effectiveness of the communications campaign

4 weeks

Treatment Details

Interventions

• Communication Campaign

Trial Overview The study tests a communications campaign using local wastewater surveillance data on COVID-19 to see if it boosts vaccine uptake. Forty counties are split into two groups, with one receiving the campaign and the other not, to compare results.

Participant Groups

Group I: Communications Intervention Group Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Syracuse University

Lead Sponsor

Trials

54

Recruited

118,000+

Findings from Research

Effective communication strategies are crucial for improving participation in COVID-19 vaccine clinical trials, especially in the context of widespread misinformation about vaccines.

The proposed ASK (Assume, Seek, Know) approach encourages transparency about options, collaboration with stakeholders, and understanding of trial data to enhance decision-making and potentially reduce vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic. Langford, AT.[2022]

Most adverse events reported from COVID-19 vaccines were mild or moderate, indicating a generally favorable safety profile during clinical trials.

However, some viral vector-based vaccines were associated with thrombotic events, highlighting the need for ongoing studies and post-marketing surveillance to fully understand potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. Chaparro Mérida, NA., Moreno Samper, D., Lacato, AOF.[2022]

A scoping review of 11 studies found that adverse events related to COVID-19 vaccinations are generally mild to moderate, with no significant impact on daily activities and no unique patterns in vaccine-related deaths, indicating a strong safety profile for the vaccines.

The review highlights the importance of accurate public communication regarding vaccine side effects and emphasizes the need for strategies to address vaccine hesitancy, suggesting that future research should focus on diverse populations and medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. Dhamanti, I., Suwantika, AA., Adlia, A., et al.[2023]

A survey of participants in a mixed vaccination protocol for Sars-CoV2 revealed that only 30% remained symptom-free after vaccination, indicating a higher incidence of adverse effects compared to pivotal trials.

Over 26% of vaccinees experienced severe symptoms that required them to stay home, with an average of 1.5 days of sick leave, highlighting the need for awareness of potential side effects in future vaccination campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events of Sars-CoV2 vaccines: Experiences from a health care worker vaccination campaign in two municipal hospitals in northwest Germany. Kermer, P., Abdalla, Y., Klein, G., et al.[2023]

In a study of 1047 Chinese adults, 81.8% of those who intended to get vaccinated against COVID-19 actually received the vaccine, highlighting a strong correlation between vaccination intention and actual uptake.

Key factors influencing vaccine uptake included prior intention to vaccinate, belief in vaccine safety, and community recommendations, while vaccine supply shortages negatively impacted vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From COVID-19 Vaccination Intention to Actual Vaccine Uptake: A Longitudinal Study Among Chinese Adults After Six Months of a National Vaccination Campaign. Wang, J., Zhu, H., Lai, X., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Increased Vaccine Uptake Among Eligible Patients at a Veterans Affairs Hospital Through an Inpatient COVID-19 Vaccination Program, Atlanta, Georgia, 2021. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Inpatient Influenza and Pneumococcal Vaccination Acceptance Rates With Pharmacist Education. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Influenza Vaccine Effectiveness in Inpatient and Outpatient Settings in the United States, 2015-2018. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel. [2023]

7. Peru pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Communications to Promote Interest and Confidence in COVID-19 Vaccines. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Acute adverse events of Sars-CoV2 vaccines: Experiences from a health care worker vaccination campaign in two municipal hospitals in northwest Germany. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Experimental pre-tests of public health communications on the COVID-19 vaccine: A null finding for medical endorsement, risk and altruism. [2022]

12. England pubmed.ncbi.nlm.nih.gov

From COVID-19 Vaccination Intention to Actual Vaccine Uptake: A Longitudinal Study Among Chinese Adults After Six Months of a National Vaccination Campaign. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Building Confidence to CONVINCE. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Factors associated with COVID-19 vaccine intentions during the COVID-19 pandemic; a systematic review and meta-analysis of cross-sectional studies. [2022]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of intention to vaccinate against COVID-19: Results of a nationwide survey. [2022]