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

30 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 Virtual Counseling for COVID-19 Vaccine Hesitancy?

Research suggests that interventions involving healthcare professionals, such as motivational interviewing and counseling, can be effective in addressing vaccine hesitancy by improving communication and trust between patients and providers. These approaches have shown promise in increasing vaccine uptake, although more evidence is needed to establish clear guidance. ^{1 2 3 4 5}

Is virtual counseling for COVID-19 vaccine hesitancy safe?

The research does not provide specific safety data for virtual counseling methods like webinars or online training for COVID-19 vaccine hesitancy, but these methods are generally considered safe as they involve educational and interactive communication rather than medical interventions. ^{5 6 7 8 9}

How does virtual facilitation differ from other treatments for COVID-19 vaccine hesitancy?

Virtual facilitation is unique because it uses online platforms to provide counseling and support, often incorporating motivational interviewing techniques, which focus on collaborative communication to address vaccine hesitancy. This approach is different from traditional methods that may not effectively engage individuals or address their specific concerns about vaccines. ^{1 2 5 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to test if virtual facilitation (e.g., video coaching) increases rural pharmacists' ability to implement COVID-19 vaccine hesitancy counseling when compared to a "standard" implementation approach (e.g., training and dissemination of implementation support tools) in rural pharmacies. The main question it aims to answer is if virtual facilitation improves fidelity to a newly developed vaccine hesitancy counseling intervention when compared to standard implementation. All participants will begin in the standard implementation condition, where they will complete a webinar on COVID-19 vaccinations and a 30-minute online training on vaccine hesitancy communication. After standard implementation, they will switch to the virtual facilitation condition where they will be assigned a virtual coach to help them with implementing the intervention. There will be six fidelity observations per each 8-week intervention period to determine whether pharmacists are implementing the intervention as intended. Researchers will compare fidelity between the standard and virtual facilitation conditions.

Research Team

Delesha M Carpenter, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Geoffrey Curran, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Exemptions From Mandatory Immunization After Legally Mandated Parental Counseling. [2020]

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

Motivational Interviewing Strategies for Addressing COVID-19 Vaccine Hesitancy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Interventions for COVID-19 Vaccine Hesitancy: A Systematic Review and Narrative Synthesis. [2023]

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

Reducing COVID-19 Vaccine Hesitancy by Implementing Organizational Intervention in a Primary Care Setting in Bahrain. [2021]

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

Addressing the Challenges of Vaccine Hesitancy Broadly and Related to COVID-19 Vaccines. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Changing Mindsets About Side Effects of the COVID-19 Vaccination: A Randomized Controlled Trial. [2023]

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

An Interactive COVID-19 Vaccine Hesitancy Workshop for Internal Medicine Residents and Medical Students. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Reporting of Post-Vaccination Symptoms for Inactivated COVID-19 Vaccines in Jordan: A Cross-Sectional Study. [2023]

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

Vaccination Intention Following Receipt of Vaccine Information Through Interactive Simulation vs Text Among COVID-19 Vaccine-Hesitant Adults During the Omicron Wave in Germany. [2023]

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

Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation. [2023]

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

Preparing student-pharmacists to utilize motivational interviewing techniques to address COVID-19 vaccine hesitancy in underrepresented racial/ethnic patient populations. [2023]