Actively Recruiting

Phase Not Applicable
Age: 8Years - 99Years
All Genders
ID06535139

ReMARk: A Multi-level Intervention Addressing Disparities in Rural HPV-related Cancer Prevention: Part 3- Evaluation

Led by University of Florida · Updated on 2025-09-09

4630

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to address disparities in HPV-related cancer prevention in rural areas by evaluating the effects of different strategies to increase HPV vaccination rates among 9- to 12-year-olds. The study focuses on improving clinician recommendations, parental motivation, and healthcare access in 11 rural North Central Florida counties. It uses a three-arm cluster randomized design to compare these approaches and understand how patient and clinic factors influence their success. The study involves three groups of clinics receiving layered interventions. All clinics get clinician-targeted recommendation training via a one-hour online session focused on empathetic communication and vaccine promotion. Some clinics also receive parent-targeted motivational aids, including reminder messages and phone-based motivational interviews for parents who do not respond. A subset of clinics receives additional community-targeted healthcare access support, such as transportation help, mobile vaccination clinics, and health insurance navigation. Participants include adolescents aged 8 to 12 who visit participating clinics and have not completed HPV vaccination. Researchers will monitor HPV vaccine initiation over 24 months and track vaccination up-to-date status. Data collection includes clinic records and patient-level information, with statistical models accounting for clinic clustering. The trial lasts at least 24 months, with interventions delivered at the clinic level and ongoing assessments of vaccination uptake and implementation success.

CONDITIONS

Brief Title

ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention

Who Can Participate

Age: 8Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents aged 8 to 12 years
  • Visited a participating clinic in the past year or during the study
  • Have not received both doses of the HPV vaccine
  • Receive primary care from providers at a participating clinic
Not Eligible

You will not qualify if you...

  • Adolescents outside the 8 to 12 years age range
  • Providers unwilling to consent to participate

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) to confirm eligibility

Treatment

Duration - Up to 24 months

Participants receive interventions based on their clinic's assigned group, including clinician training, parent-targeted motivational messages and phone-based interviews, and/or healthcare access support such as transportation assistance and mobile vaccination clinics.

Ongoing interventions through clinic visits and outreach; mobile vaccination clinics offered approximately 40 times during the intervention period

Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

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Research Team

S

Stephanie Staras, PhD

M

Marta Hansen, MBA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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