COVID-19NCT06547814
COVID-19 Vaccine Hesitancy Counseling Intervention for Pharmacists: A Stepped-Wedge Trial
A study testing Standard implementation webinar and online training and Virtual facilitation in people with COVID-19, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Standard implementation webinar and online training and Virtual facilitation
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The pharmacy will be excluded if it does not offer COVID-19 vaccines.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Addressing COVID-19 Vaccine Hesitancy in Rural Community Pharmacies Reducing Disparities Through an Implementation Science Approach
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.
Read the detailed description
Because COVID-19 vaccination conversations are sensitive and often politically charged, pharmacists need implementation support, including training and ongoing guidance to deliver evidence-based vaccine hesitancy counseling interventions. Implementation facilitation, in which trained facilitators coach and troubleshoot problems with professionals as they implement new practices, increases adoption of practices with fidelity. However, implementation facilitation generally, and virtual facilitation (e.g., video coaching) in particular, has not been systematically studied in community pharmacy settings.
The goal of this study is to test if virtual facilitation 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). Using a rural pharmacy practice-based research network (PBRN) that spans 7 southeastern states, the investigators will conduct a stepped-wedge trial with 30 rural pharmacies to test whether virtual facilitation outperforms the standard approach in increasing the fidelity with which pharmacists implement the vaccine hesitancy counseling intervention. Using a project-sponsored data collection system, the investigators will gather data on implementation outcomes, including fidelity and effectiveness.
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 the standard implementation period, they will cross over 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. Based on a proposed Fall 2024 vaccine administration schedule by the Federal Drug Administration, the investigators anticipate implementing the study over two vaccination seasons (Fall 2024 and Fall 2025).
- Conditions
- COVID-19
- Being tested
- Standard implementation webinar and online training, Virtual facilitation
- Keywords
- vaccine hesitancy, fidelity, vaccination, pharmacy
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard implementation webinar and online trainingBehavioural
The one-hour webinar (either live or pre-recorded) will include updated information about the COVID-19 virus, variant nomenclature, vaccine eligibility, mechanisms of action, and outcomes. The 30-minute online training addresses how to communicate about COVID-19 vaccinations, presents a 5-step process for initiating conversations, includes example verbiage about how to address specific concerns, and has example videos that show how to implement the 5-step process with vaccine hesitant patients.
Virtual facilitationBehavioural
This intervention involves a 30-minute virtual facilitation site visit and at least 8, 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom will establish the personnel and workflows at each pharmacy and allow the facilitator to establish rapport. Weekly Zoom calls will allow the virtual facilitator to work with a participant to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. Lastly, either the facilitator or the participant can request and schedule a Zoom call to go over any pressing implementation issue in need of rapid attention (e.g., technical difficulties with the website).
| Study group | Role | What they receive |
|---|---|---|
| Standard implementation (Stage 1) | Experimental | Participants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. Receives: Behavioral: Standard implementation webinar and online training |
| Virtual facilitation (Stage 2) | Experimental | After completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment. Receives: Behavioral: Virtual facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fidelity Score
The fidelity measure focuses on the competence and skill of the pharmacist (7 items with values ranging from 1 to 3) in their delivery of the vaccine hesitancy counseling intervention. Items assess whether they expressed empathy, used non-confrontational manner, spoke confidently without using jargon, emphasized patient autonomy, reflected back patient's statements accurately, and used a respectful demeanor. The overall composite competency score is the sum of the 7 items with scores ranging from 7 to 21, with higher scores reflecting greater competency in the delivery of the vaccine hesitancy intervention. Fidelity will be measured for each pharmacist six times per each 8-week intervention period under the standard implementation approach and the virtual facilitation approach. In pharmacies with more than one pharmacist, fidelity ratings will be averaged to achieve a pharmacy-level measure.
Measured: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.
Secondary outcomes (1)
Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine
Effectiveness will be calculated as the proportion of patients who received the vaccine hesitancy counseling intervention who chose to get the COVID-19 vaccine. Pharmacists at each pharmacy were asked to document 30 conversations (10 per 8-week period). Pharmacists documented whether each of the patients elected to get the COVID-19 vaccine after their conversation.
Measured: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 Aug 2024
- Primary completion7 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The investigators will use an incomplete stepped wedge cluster randomized design, where units (pharmacies) begin in one condition (standard implementation approach) and "crossover" to the other condition (virtual facilitation).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, University of South Carolina, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Delesha M Carpenter, PhD, Principal investigator, University of North Carolina, Chapel HillGeoffrey Curran, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547814
- Sponsor's protocol ID
- 22-2602b
- Other IDs
- 1R01MD018085
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2024
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Curran GM, Shoemaker SJ. Advancing pharmacy practice through implementation science. Res Social Adm Pharm. 2017 Sep-Oct;13(5):889-891. doi: 10.1016/j.sapharm.2017.05.018. Epub 2017 Jun 1. No abstract available.
PubMed 28619650Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.
PubMed 30821830Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI Series. Implement Sci. 2008 Mar 19;3:17. doi: 10.1186/1748-5908-3-17.
PubMed 18353186Parchman ML, Noel PH, Culler SD, Lanham HJ, Leykum LK, Romero RL, Palmer RF. A randomized trial of practice facilitation to improve the delivery of chronic illness care in primary care: initial and sustained effects. Implement Sci. 2013 Aug 22;8:93. doi: 10.1186/1748-5908-8-93.
PubMed 23965255Knox L. Module 2: Practice Facilitation as a Resource for Practice Improvement. In: Quality AfHRa, ed. pcmh.ahrq.gov: AHRQ; 2015.
Shackley AG, Carpenter DM, Charton H, Teeter BS, Smith M, Hastings TJ, Hughes T, Curran G. Lessons learned in optimizing recruitment and data collection for a pharmacy-based implementation trial. J Am Pharm Assoc (2003). 2026 Jan-Feb;66(1):102972. doi: 10.1016/j.japh.2025.102972. Epub 2025 Nov 3.
PubMed 41192509
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing COVID-19 Vaccine Hesitancy in Rural Community Pharmacies Reducing Disparities Through an Implementation Science Approach
- ClinicalTrials.gov ID
- NCT06547814
- Acronym / sponsor ID
- 22-2602b
- Conditions
- COVID-19
- Keywords
- vaccine hesitancy, fidelity, vaccination, pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Arkansas, University of South Carolina, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Because COVID-19 vaccination conversations are sensitive and often politically charged, pharmacists need implementation support, including training and ongoing guidance to deliver evidence-based vaccine hesitancy counseling interventions. Implementation facilitation, in which trained facilitators coach and troubleshoot problems with professionals as they implement new practices, increases adoption of practices with fidelity. However, implementation facilitation generally, and virtual facilitation (e.g., video coaching) in particular, has not been systematically studied in community pharmacy settings.
The goal of this study is to test if virtual facilitation 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). Using a rural pharmacy practice-based research network (PBRN) that spans 7 southeastern states, the investigators will conduct a stepped-wedge trial with 30 rural pharmacies to test whether virtual facilitation outperforms the standard approach in increasing the fidelity with which pharmacists implement the vaccine hesitancy counseling intervention. Using a project-sponsored data collection system, the investigators will gather data on implementation outcomes, including fidelity and effectiveness.
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 the standard implementation period, they will cross over 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. Based on a proposed Fall 2024 vaccine administration schedule by the Federal Drug Administration, the investigators anticipate implementing the study over two vaccination seasons (Fall 2024 and Fall 2025).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will use an incomplete stepped wedge cluster randomized design, where units (pharmacies) begin in one condition (standard implementation approach) and "crossover" to the other condition (virtual facilitation).
| Arm | Type | Receives |
|---|---|---|
| Standard implementation (Stage 1) | Experimental | Behavioral: Standard implementation webinar and online trainingParticipants begin with the standard implementation interventions for 8-16 weeks, depending on random block assignment. |
| Virtual facilitation (Stage 2) | Experimental | Behavioral: Virtual facilitationAfter completing the standard implementation, participants then complete the virtual facilitation intervention for 8-16 weeks, depending on random block assignment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The pharmacy will be excluded if it does not offer COVID-19 vaccines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard implementation webinar and online trainingThe one-hour webinar (either live or pre-recorded) will include updated information about the COVID-19 virus, variant nomenclature, vaccine eligibility, mechanisms of action, and outcomes. The 30-minute online training addresses how to communicate about COVID-19 vaccinations, presents a 5-step process for initiating conversations, includes example verbiage about how to address specific concerns, and has example videos that show how to implement the 5-step process with vaccine hesitant patients. | Behavioural | Standard implementation (Stage 1) |
| Virtual facilitationThis intervention involves a 30-minute virtual facilitation site visit and at least 8, 30-minute virtual facilitator coaching sessions. The virtual site visit over Zoom will establish the personnel and workflows at each pharmacy and allow the facilitator to establish rapport. Weekly Zoom calls will allow the virtual facilitator to work with a participant to review overall implementation challenges associated with approaching patients, delivering the intervention, and documenting results. Lastly, either the facilitator or the participant can request and schedule a Zoom call to go over any pressing implementation issue in need of rapid attention (e.g., technical difficulties with the website). | Behavioural | Virtual facilitation (Stage 2) |
Primary outcome
Mean Fidelity Score
Time frame: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.
The fidelity measure focuses on the competence and skill of the pharmacist (7 items with values ranging from 1 to 3) in their delivery of the vaccine hesitancy counseling intervention. Items assess whether they expressed empathy, used non-confrontational manner, spoke confidently without using jargon, emphasized patient autonomy, reflected back patient's statements accurately, and used a respectful demeanor. The overall composite competency score is the sum of the 7 items with scores ranging from 7 to 21, with higher scores reflecting greater competency in the delivery of the vaccine hesitancy intervention. Fidelity will be measured for each pharmacist six times per each 8-week intervention period under the standard implementation approach and the virtual facilitation approach. In pharmacies with more than one pharmacist, fidelity ratings will be averaged to achieve a pharmacy-level measure.
1 secondary outcome
Proportion of Individuals Receiving Vaccine Hesitancy Counseling Who Chose to Get the COVID-19 Vaccine
Time frame: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28619650Curran GM, Shoemaker SJ. Advancing pharmacy practice through implementation science. Res Social Adm Pharm. 2017 Sep-Oct;13(5):889-891. doi: 10.1016/j.sapharm.2017.05.018. Epub 2017 Jun 1. No abstract available.
- Background: PubMed 30821830Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.
- Background: PubMed 18353186Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI Series. Implement Sci. 2008 Mar 19;3:17. doi: 10.1186/1748-5908-3-17.
- Background: PubMed 23965255Parchman ML, Noel PH, Culler SD, Lanham HJ, Leykum LK, Romero RL, Palmer RF. A randomized trial of practice facilitation to improve the delivery of chronic illness care in primary care: initial and sustained effects. Implement Sci. 2013 Aug 22;8:93. doi: 10.1186/1748-5908-8-93.
- BackgroundKnox L. Module 2: Practice Facilitation as a Resource for Practice Improvement. In: Quality AfHRa, ed. pcmh.ahrq.gov: AHRQ; 2015.
- Background: PubMed 41192509Shackley AG, Carpenter DM, Charton H, Teeter BS, Smith M, Hastings TJ, Hughes T, Curran G. Lessons learned in optimizing recruitment and data collection for a pharmacy-based implementation trial. J Am Pharm Assoc (2003). 2026 Jan-Feb;66(1):102972. doi: 10.1016/j.japh.2025.102972. Epub 2025 Nov 3.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delesha M Carpenter, PhD principal investigator
University of North Carolina, Chapel Hill
Geoffrey Curran, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard implementation webinar and online training and Virtual facilitation in people with COVID-19, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Fidelity Score (time frame: From baseline through the end of the virtual facilitation periods, up to 24 weeks maximum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547814, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.