Human Papillomavirus VaccinesNCT04587167

HPV Vaccine Communication ECHO for Primary Care Clinics

A study testing Project ECHO, Announcement Approach Training and Recall notices in people with Human Papillomavirus Vaccines and Adolescent Health Services, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Vaccines, Adolescent Health Services
What is being tested?: Project ECHO, Announcement Approach Training and Recall notices
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 May 2021to 30 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Family medicine or pediatric clinic in Pennsylvania
Having at least 100 active patients, ages 11-14.
Parent or guardian of an adolescent ages 11-17
Adolescent has not yet started HPV vaccination
Adolescent receive primary care at participating clinic

Who cannot join

Primary care clinic outside Pennsylvania
Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.
Parents in nested study survey
Not the parent or guardian of an adolescent ages 11-17
Adolescent already initiated HPV vaccination
Adolescent does not receive primary care at participating clinic

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State College of Medicine
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices

The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.

Read the detailed description

The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.

Conditions: Human Papillomavirus Vaccines, Adolescent Health Services
Being tested: Project ECHO, Announcement Approach Training, Recall notices

What participants receive

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

Project ECHOOther
Also called ECHO Model
Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.
Announcement Approach TrainingOther
Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.
Recall noticesOther
Notify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.

Study groups in NCT04587167
Study group	Role	What they receive
HPV ECHO	Experimental	Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times. Receives: Other: Project ECHO; Other: Announcement Approach Training
HPV ECHO+	Experimental	Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania. Receives: Other: Project ECHO; Other: Announcement Approach Training; Other: Recall notices
Control	No intervention	Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.

What is being measured

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

HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
Measured: Twelve months

Secondary outcomes (13)

HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months
Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
Measured: Three months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
Measured: Six months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months
Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
Measured: Nine months
HPV Vaccination (Completion), 11-14 Year Olds at 3 Months
Coverage change from baseline to 3 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records
Measured: Three months
HPV Vaccination (Completion), 11-14 Year Olds at 6 Months
Coverage change from baseline to 6 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records
Measured: Six months
HPV Vaccination (Completion), 11-14 Year Olds at 9 Months
Coverage change from baseline to 9 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records
Measured: Nine months
HPV Vaccination (Completion), 11-14 Year Olds at 12 Months
Coverage change from baseline to 12 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records
Measured: Twelve months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months
Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records
Measured: Three months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records
Measured: Six months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months
Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records
Measured: Nine months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records
Measured: Twelve months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients by sex, as measured by clinics' records
Measured: Twelve months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients by sex, as measured by clinics' records
Measured: Twelve months

Timeline

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

1 May 202130 Apr 2025

First posted14 Oct 2020
Study start1 May 2021
Primary completion30 Sep 2024
Study completion30 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 (1)Papers the sponsor has linked to this study.
Other trials for Human Papillomavirus VaccinesStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe 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: Parallel groups
Model description: Cluster randomized design
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04587167
Sponsor's protocol ID: STUDY00015734
Other IDs: R37CA253279
Status last verified: Feb 2026
First submitted: 7 Oct 2020
Last updated: 24 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No raw data will be shared with the general public or other researchers.

Publications

Calo WA, Shah PD, Fogel BN, Ruffin Iv MT, Moss JL, Hausman BL, Segel JE, Francis E, Schaefer E, Bufalini CM, Johnston N, Hogentogler E, Kraschnewski JL. Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107266. doi: 10.1016/j.cct.2023.107266. Epub 2023 Jun 9.
PubMed 37301468

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination

All Human Papillomavirus Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices
ClinicalTrials.gov ID: NCT04587167
Acronym / sponsor ID: STUDY00015734
Conditions: Human Papillomavirus Vaccines, Adolescent Health Services
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 May 2021 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 24 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Cluster randomized design

Arm	Type	Receives
HPV ECHO	Experimental	Other: Project ECHO, Other: Announcement Approach TrainingClinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
HPV ECHO+	Experimental	Other: Project ECHO, Other: Announcement Approach Training, Other: Recall noticesClinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
Control	No intervention	–Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Family medicine or pediatric clinic in Pennsylvania
Having at least 100 active patients, ages 11-14.
Parent or guardian of an adolescent ages 11-17
Adolescent has not yet started HPV vaccination
Adolescent receive primary care at participating clinic

Key exclusion criteria (6 listed)

Primary care clinic outside Pennsylvania
Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.
Parents in nested study survey
Not the parent or guardian of an adolescent ages 11-17
Adolescent already initiated HPV vaccination

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
Project ECHOAlso: ECHO ModelUsing proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.	Other	HPV ECHO, HPV ECHO+
Announcement Approach TrainingTrain physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.	Other	HPV ECHO, HPV ECHO+
Recall noticesNotify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.	Other	HPV ECHO+

Primary outcome

HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
Time frame: Twelve months
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records

13 secondary outcomes

HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months
Time frame: Three months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months
Time frame: Six months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months
Time frame: Nine months
HPV Vaccination (Completion), 11-14 Year Olds at 3 Months
Time frame: Three months
HPV Vaccination (Completion), 11-14 Year Olds at 6 Months
Time frame: Six months
HPV Vaccination (Completion), 11-14 Year Olds at 9 Months
Time frame: Nine months
HPV Vaccination (Completion), 11-14 Year Olds at 12 Months
Time frame: Twelve months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months
Time frame: Three months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months
Time frame: Six months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months
Time frame: Nine months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months
Time frame: Twelve months
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex
Time frame: Twelve months
HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex
Time frame: Twelve months

Results and safety

Results posted to the registry on 24 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HPV ECHO	11,477	11,473
HPV ECHO+	10,401	10,401
Control	9,387	9,382

Primary outcome: HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months

Time frame: Twelve months. Count of participants. Unit: Participants

Measure	HPV ECHO n = 6537	HPV ECHO+ n = 5901	Control n = 5410
Value	3189 (2)	3833 (2)	4260 (2)

Population analysed: These numbers reflect only patients 11-14 years of age to align with the outcome measure. Enrolled clinics were instructed to follow the same cohort of active patients defined at baseline. However, limitations in EHR reporting and data support led to inconsistencies in data submission, resulting in minor variations in total counts across the reporting period.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the one-year study enrollment period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HPV ECHO	0 of 10 (0%)	0 of 10 (0%)	0 of 10
HPV ECHO+	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Challenges occurred in obtaining aggregate immunization data. Three clinics did not submit data, and others could not consistently follow the same patient cohort across time points, resulting in inconsistencies. The study team collaborated with clinics and EHR servicers to ensure the highest possible data quality.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37301468Calo WA, Shah PD, Fogel BN, Ruffin Iv MT, Moss JL, Hausman BL, Segel JE, Francis E, Schaefer E, Bufalini CM, Johnston N, Hogentogler E, Kraschnewski JL. Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107266. doi: 10.1016/j.cct.2023.107266. Epub 2023 Jun 9.
Individual participant dataSharing planned: No. No raw data will be shared with the general public or other researchers.

Related trials for Human Papillomavirus Vaccines

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
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Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
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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.

William A Calo, PhD, JD, MPH principal investigator

Penn State College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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 24 Feb 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 24 Feb 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?

HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months (time frame: Twelve months). 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 NCT04587167, which also lists 1 linked publication.

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 24 Feb 2026.