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InfluenzaPCP-VAXNCT07651761

Patient-Centered Practical Vaccine Talk For Busy Clinicians

A study testing Provider communication training in people with Influenza and COVID-19, run by University of Massachusetts, Worcester at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza, COVID-19
What is being tested?
Provider communication training
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24,500 participants
Where
1 siteUnited States
Study dates
24 Jun 2026to 15 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion criteria for primary care provider participants are as follows:

  • Practicing primary care provider at study clinic during the study period
  • Licensed independent practitioner (MD, DO, NP, PA), including residents

Exclusion criteria for primary care provider participants are as follows:

  • PCPs at participating clinic sites who are members of the investigational team or part of the intervention
  • PCP participants who practice at more than one study clinic that are assigned to discordant study arms (e.g., control and intervention) will be excluded at the outset of the study.

Inclusion criteria for patient participants are specified for each of the two co-primary outcomes as follows:

Receipt of the 2026/2027 influenza vaccine, among eligible patients:

  • Have a qualifying clinic visit, defined as a clinic visit with a study PCP at one of the study clinics during the 2026/2027 influenza vaccine season*
  • Have not received the 2026-2027 influenza vaccine prior to the qualifying clinic visit (patients who receive the influenza vaccine on the day of the qualifying study visit are eligible)
  • Adult (age >= 18 years)

Receipt of the 2026/2027 COVID-19 vaccine, among eligible patients:

  • Have a qualifying clinic visit, defined as a clinic visit with a study PCP at one of the study clinics during the 2026/2027 COVID-19 vaccine season*
  • Have not received the 2026-2027 COVID-19 vaccine prior to the qualifying study visit (patients who receive the COVID-19 vaccine on the day of the qualifying study visit are eligible)
  • Have at least one risk factor for developing severe COVID-19 according to the CDC, including age >= 65 years
  • Adult (age >= 19 years)

Exclusion criteria for patient participants for both co-primary outcomes are the following:

  • Resident of a state that does not share immunization data with the Massachusetts Immunization Information System (MIIS)

For the purposes of this study, the 2026/2027 influenza and COVID-19 vaccine seasons are defined as September 1, 2026, or date the respective vaccine is available (whichever is later) through February 28, 2027. These dates were selected based on the timing of influenza and COVID-19 vaccine administration in prior years according to the Massachusetts immunization for respiratory disease data. This is referred to as the 'study period' elsewhere in the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • UMass Chan Medical School

    Worcester, Massachusetts, 01602

Other trials in United States

About this study

Official title: Patient-Centered Practical Vaccine Talk for Busy Clinicians (PCP-VAX): An Educational Intervention for Primary Care Providers on Influenza and COVID-19 Vaccine Uptake Among Adult Primary Care Patients

The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics.

Read the detailed description

Low uptake of the COVID-19 and influenza vaccines is a major public health threat. An estimated 234,000 deaths due to COVID-19 could have been prevented between June 2021 and March 2022 through vaccination. Yet, only 20% of US adults are up to date on COVID-19 vaccination, despite widespread vaccine availability, and evidence of vaccine effectiveness at preventing hospitalization or death. Similarly, flu shots prevented an estimated 105,000 hospitalizations and 6,300 deaths during the 2019-2020 season alone, but only 50% of adults received a flu shot in the 2020-2021 influenza season, and these rates have been declining in the years since.

Healthcare provider (HCP) recommendations increase uptake of COVID-19 and influenza vaccines. Interventions that leverage the central role of HCPs in recommending vaccination are a promising means of increasing vaccination coverage. Yet many PCPs are unsure how to communicate effectively with patients who decline vaccination, indicating a need for strategies and training in how to effectively communicate with patients about the COVID-19 and influenza vaccines.

The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics. Our hypothesis is that training PCPs in evidence-based communication strategies (e.g., making a presumptive recommendation, responding with elements of MI) via the PCP-VAX intervention will be superior to usual care with regards to influenza and COVID-19 vaccine uptake. The trial will be conducted among primary care clinics from 3 health systems in central Massachusetts, including community primary care practices, academic primary care practices, and Federally Qualified Health Centers.

Conditions
Influenza, COVID-19
Being tested
Provider communication training
Keywords
prevention, provider training
Medical subject headings
Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provider communication trainingOther

    Providers in participating intervention clinics will complete an educational program (PCP-VAX) on strategies for communicating with patients about the influenza and COVID-19 vaccines.

Study groups in NCT07651761
Study groupRoleWhat they receive
Intervention ArmOtherProvider educational intervention.
Receives: Other: Provider communication training
Control ArmNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Receipt of 2026/2027 influenza vaccine

    Binary variable, yes/no

    Measured: Within one month of the end of the study period

  2. Receipt of 2026/2027 COVID-19 vaccine

    Binary variable, yes/no

    Measured: Within one month of the end of the study period

Secondary outcomes (1)

  1. PCP self-efficacy in communicating with patients about vaccination, assessed via 4-questions developed for this study (4-point Likert scale)

    Measured: Up to 8-months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start24 Jun 2026
  3. Primary completion15 May 2028 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07651761
Sponsor's protocol ID
STUDY00001814
Other IDs
R01MD018611
Acronym
PCP-VAX
Status last verified
Jun 2026
First submitted
4 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data, data dictionaries, and statistical code will be made available in the eScholarship@UMassChan repository at the time of publication.

Questions about this trial

What is this clinical trial studying?

A study testing Provider communication training in people with Influenza and COVID-19, run by University of Massachusetts, Worcester 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?

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: enrolling by invitation, as of the sponsor's last update on 29 Jun 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?

This study is still under way. Results are not available in the source record yet.

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?

Receipt of 2026/2027 influenza vaccine (time frame: Within one month of the end of the study period). The study lists 2 primary outcomes in all. 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 NCT07651761.

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 29 Jun 2026.

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