Virtual Counseling for COVID-19 Vaccine Hesitancy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Not offering COVID-19 vaccines

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether virtual coaching (referred to as virtual facilitation) can help rural pharmacists better counsel individuals hesitant about receiving the COVID-19 vaccine. It compares this virtual support to a typical approach involving a webinar and online training. Participating pharmacists will initially use the standard method and then switch to virtual coaching to determine which is more effective. Pharmacies in the RURAL-CP, located in counties with a significant African American population or a high percentage of Republican voters, are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in healthcare communication.

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 prior data suggests that this virtual facilitation method is safe for use in vaccine hesitancy counseling?

Research has shown that virtual methods, such as video coaching, safely address vaccine concerns. No reports have linked negative effects directly to these virtual methods. They function like a video chat to help individuals better understand and discuss the COVID-19 vaccine.

While virtual methods are safe, some people might feel unwell after vaccination due to the "nocebo effect," where expecting side effects can cause them to occur.

In summary, virtual methods safely share vaccine information, building confidence and understanding about the COVID-19 vaccine without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual facilitation for COVID-19 vaccine hesitancy because it offers a fresh approach to tackling the issue. Unlike traditional in-person counseling or public health campaigns, this method leverages virtual technology, making it more accessible and potentially reaching a larger audience. By providing a structured online intervention, it could offer personalized support and flexibility, allowing participants to engage at their own pace and comfort level. This approach could be particularly effective in addressing specific concerns and misinformation, which are key barriers to vaccine acceptance.

What evidence suggests that virtual facilitation is effective for improving COVID-19 vaccine hesitancy counseling?

Research has shown that virtual tools can help people feel more positive about vaccines. One study found that virtual reality increased the willingness to get vaccinated by 9.3 points among those initially unsure. Another study discovered that virtual methods, including motivational conversations, made people more comfortable with vaccination. In this trial, participants will first undergo the standard implementation intervention, followed by the virtual facilitation intervention. These findings suggest that virtual approaches, like those tested in this trial, could effectively reduce vaccine hesitancy, especially in rural areas. This method aims to make vaccine information clearer and more relatable, encouraging more people to get vaccinated. ^{6 7 8 9 10}

Who Is on the Research Team?

Delesha M Carpenter, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Geoffrey Curran, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for rural pharmacists who are looking to improve their ability to counsel patients with COVID-19 vaccine hesitancy. Participants should be currently practicing in a rural pharmacy and willing to undergo training and coaching sessions.

Inclusion Criteria

The pharmacy must be a member of the Rural Research Alliance for Community Pharmacies (RURAL-CP)

The pharmacy must be located in a county that has an African American population of at least 25% or had at least 51% of the population vote for a Republican president in 2020.

Exclusion Criteria

My pharmacy offers COVID-19 vaccines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Implementation

Participants complete a webinar on COVID-19 vaccinations and a 30-minute online training on vaccine hesitancy communication

8-16 weeks

6 fidelity observations per 8-week period

Virtual Facilitation

Participants are assigned a virtual coach to help implement the intervention

8-16 weeks

6 fidelity observations per 8-week period

Follow-up

Participants are monitored for fidelity and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard implementation webinar and online training
• Virtual facilitation

Trial Overview

The study tests if virtual coaching helps pharmacists better implement COVID-19 vaccine hesitancy counseling compared to just webinar training. Pharmacists start with standard online training, then move on to personalized video coaching, with their performance observed over time.

How Is the Trial Designed?

Group I: Virtual facilitation (Stage 2) Experimental Treatment 1 Intervention

After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment.

Group II: Standard implementation (Stage 1) Experimental Treatment 1 Intervention

Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Published Research Related to This Trial

A systematic review of six studies involving over 200,000 participants found that most non-financial interventions effectively increased COVID-19 vaccination rates, although one study was a randomized controlled trial.

Despite the positive results, the evidence on the effectiveness of these interventions is still limited, highlighting the need for more rigorous research to develop clear guidelines for addressing vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for COVID-19 Vaccine Hesitancy: A Systematic Review and Narrative Synthesis. Terrell, R., Alami, A., Krewski, D.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05926544

COVID-19 Vaccine Hesitancy Counseling Intervention for ...

The goal of this study is to test if virtual facilitation increases rural pharmacists' ability to implement COVID-19 vaccine hesitancy counseling when compared ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10726603/

Addressing COVID-19 vaccine hesitancy in rural ...

During virtual facilitation, trial facilitators will be provided with bi-weekly effectiveness data so they can share the results with the ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423002483

Developing and testing a COVID-19 vaccination ...

This trial tests a virtual COVID-19 Vaccine Acceptance Intervention (VAI) training, informed by motivational interviewing, to improve vaccine acceptance among ...

4.

nature.com

nature.com/articles/s41598-022-08120-4

Virtual reality reduces COVID-19 vaccine hesitancy in the ...

After the VR treatment, for participants with less-than-maximal vaccination intention, intention increases by 9.3 points (95% CI: 7.0 to ). The ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11680215/

Determinants of COVID-19 Vaccine Acceptance and Hesitancy

This review aims to identify and analyze studies addressing two key questions: what influences the decision to vaccinate and what factors are ...

6.

liebertpub.com

liebertpub.com/doi/10.1177/29941520251377072

Using Intervention Mapping to Develop a Virtual Reality ...

Our primary outcome, based on the population's needs, was to improve COVID-19 vaccine uptake in the pediatric population. The secondary outcome ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8928717/

Virtual reality reduces COVID-19 vaccine hesitancy in the ...

After the VR treatment, for participants with less-than-maximal vaccination intention, intention increases by 9.3 points (95% CI: 7.0 to 11.5 , p < 0.001 ). The ...

8.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2021.757283/full

Implications of COVID-19 Vaccine Hesitancy

Reluctance to accept vaccination against COVID-19 poses a significant public health risk and is known to be a multi-determined phenomenon.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X25008266

COVID-19 vaccine hesitancy and perceived post- ...

Vaccine hesitancy prospectively predicts nocebo side-effects following COVID-19 vaccination. Sci Rep, 12 (2022), p. 20018, 10.1038/s41598-022 ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8590854/

Virtual town halls addressing vaccine hesitancy among racial ...

Nonhesitant participants reported greater trust in the COVID-19 Task Force (97.3% vs. 83.3%) as a source of vaccine information than did hesitant participants.