Papillomavirus VaccinesNCT05148559
Impact of Adolescent Vaccine Reminder Notices Sent Via Preferred Method of Communication on HPV Vaccination
A study testing Reminder Sent Via Preferred Method of Communication and Reminder Sent Via Mailed Letter in people with Papillomavirus Vaccines, run by Huong Nguyen, PhD at 1 site in United States.
Trial summary
Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. Read more about this study
- Who is it for?
- Ages 12 to 12 years
- Conditions the study is for
- Papillomavirus Vaccines
- What is being tested?
- Reminder Sent Via Preferred Method of Communication and Reminder Sent Via Mailed Letter
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,451 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to Dec 2026
- 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 12 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Marshfield Clinic Health System patient aged 12 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
- Due for at least one adolescent vaccine (HPV, MenACWY, Tdap)
Who cannot join
- Primary care provider is not affiliated with Marshfield Clinic Health System
- Opted out of Marshfield Clinic Health System vaccine reminder notifications
- Missing or invalid contact information
- Deceased
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449
About this study
Official title: Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. This study will assess the impact by rurality of vaccine reminder notices sent via the parent's preferred method of communication on HPV vaccination among 12 year-old patients in a regional healthcare system.
- Conditions
- Papillomavirus Vaccines
- Being tested
- Reminder Sent Via Preferred Method of Communication, Reminder Sent Via Mailed Letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder Sent Via Preferred Method of CommunicationBehavioural
Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a vaccine reminder notice every other month via their preferred method of communication (text message, email, mailed letter) until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.
Reminder Sent Via Mailed LetterBehavioural
Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a mailed vaccine reminder letter every other month until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Reminder | Experimental | Not described Receives: Behavioral: Reminder Sent Via Preferred Method of Communication |
| Standard of Care | Other | Not described Receives: Behavioral: Reminder Sent Via Mailed Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data
Receipt of 1 dose of HPV vaccine within 90 days of receipt of reminder (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received 1 dose of HPV vaccine if they have record of receipt of HPV vaccine with a vaccination date during the 90-day follow-up period.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start12 Aug 2021
- Primary completion2 Nov 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus VaccinesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 5,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huong Nguyen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Huong Nguyen, PhD, Marshfield Clinic Research Foundation
- Investigators
- Huong McLean, PhD, Principal investigator, Marshfield Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148559
- Sponsor's protocol ID
- MCL10517
- Other IDs
- U01IP001093
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
- ClinicalTrials.gov ID
- NCT05148559
- Acronym / sponsor ID
- MCL10517
- Conditions
- Papillomavirus Vaccines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,451 participants (actual)
- Lead sponsor
- Huong Nguyen, PhDUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. This study will assess the impact by rurality of vaccine reminder notices sent via the parent's preferred method of communication on HPV vaccination among 12 year-old patients in a regional healthcare system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Reminder | Experimental | Behavioral: Reminder Sent Via Preferred Method of Communication |
| Standard of Care | Other | Behavioral: Reminder Sent Via Mailed Letter |
Who may qualify
- Ages
- 12 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Marshfield Clinic Health System patient aged 12 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
- Due for at least one adolescent vaccine (HPV, MenACWY, Tdap)
Key exclusion criteria (4 listed)
- Primary care provider is not affiliated with Marshfield Clinic Health System
- Opted out of Marshfield Clinic Health System vaccine reminder notifications
- Missing or invalid contact information
- Deceased
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 |
|---|---|---|
| Reminder Sent Via Preferred Method of CommunicationParents of 12 year-old patients due for ≥1 adolescent vaccine will receive a vaccine reminder notice every other month via their preferred method of communication (text message, email, mailed letter) until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13. | Behavioural | Enhanced Reminder |
| Reminder Sent Via Mailed LetterParents of 12 year-old patients due for ≥1 adolescent vaccine will receive a mailed vaccine reminder letter every other month until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13. | Behavioural | Standard of Care |
Primary outcome
Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data
Time frame: 90 days
Receipt of 1 dose of HPV vaccine within 90 days of receipt of reminder (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received 1 dose of HPV vaccine if they have record of receipt of HPV vaccine with a vaccination date during the 90-day follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Papillomavirus Vaccines
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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.
Huong McLean, PhD principal investigator
Marshfield Clinic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder Sent Via Preferred Method of Communication and Reminder Sent Via Mailed Letter in people with Papillomavirus Vaccines, run by Huong Nguyen, PhD 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 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. 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?
Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.