ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention

NCT06535139 | Recruiting DMC

• 2 other identifiers: IRB202301601R01CA268014
• Study Type: interventional
• Target: 4,630
• Locations: 1 country
• Sites: 1

Brief Summary

There are three main objectives of the protocol. First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training. Second, we will estimate the differential effectiveness of the implementation strategies by patient-level factors (age, race/ethnicity, sex, distance from home to clinic, social vulnerability). Third, we will measure moderation of implementation strategy effectiveness by clinic-level factors (HPV vaccination priority, resources, clinic visit types, scheduling practices, and implementation success). Within 11 rural North Central Florida counties, we will evaluate the layering of evidence-based implementation strategies that progressively addressing clinician, parent, and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds. To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination, we will test our hypotheses with a three-arm cluster randomized study design of nested strategies. The proposed nested study design optimizes evaluation, causal inference, and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies. Randomization will occur at the clinic level. All clinics will receive implementation strategy A: clinician-targeted recommendation training. A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids (B) for an implementation strategy package of A+B. Finally, a random half of the clinics who receive A+B will also receive community-targeted healthcare access (C) for a total implementation strategy package of A+B+C. This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone (A), 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids (A+B), and 10 clinics receive clinician-targeted recommendation training, parent-targeted motivational aids, and community-targeted healthcare access (A+B+C).

Conditions

Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

• Initiation of the HPV Vaccine

  Binary measure at the participant level of receipt of one or more does of the HPV vaccine

  24 months

Secondary Outcomes (1)

• Up to date for the HPV Vaccine

  24 months

Study Arms (3)

Clinician-targeted training

EXPERIMENTAL

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine.

Behavioral: Brief training

Clinician-targeted training and Parent-targeted motivational aids

EXPERIMENTAL

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine. Also, clinics will send reminder/recall messages to parents about the HPV vaccine and offer phone-based motivational interviews.

Behavioral: Brief training; Behavioral: Parent-targeted motivational aids

Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access

EXPERIMENTAL

All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine. Also, clinics will send reminder/recall messages to parents about the HPV vaccine and offer phone-based motivational interviews. Plus, clinics will have access to healthcare access assistance.

Behavioral: Brief training; Behavioral: Parent-targeted motivational aids; Behavioral: Healthcare access

Interventions

Brief training BEHAVIORAL

Clinicians and nurses will receive a brief training. Each training will have a one-hour didactic and interactive session and follow-up practice sessions. Trainings will focus on providers presenting the HPV vaccine as safe, best if received at 9- to 12-years of age, and prevents cancer.

Clinician-targeted training; Clinician-targeted training and Parent-targeted motivational aids; Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access

Parent-targeted motivational aids BEHAVIORAL

Parents will be sent messages via text, phone, or postcard about the HPV vaccine. Parents who do not respond to messages will be offered a phone-based motivational interview session about the HPV vaccine.

Clinician-targeted training and Parent-targeted motivational aids; Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access

Healthcare access BEHAVIORAL

Healthcare access will involve three components coordinated by UF Health Cancer Center Community Outreach and Engagement Office: transportation assistance to a participating clinic or mobile vaccination clinic, UF mobile vaccination clinic scheduling, and connection to health insurance navigators.

Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents Age 8- to 12-years-old Visited participating clinic in past year or during study No records of receiving both HPV vaccine doses
• Providers Provide 9- to 12-year-old patients primary care Practice at a participating clinic

You may not qualify if:

• Adolescents Out of age range
• Providers Unwilling to consent

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Interventions

Health Care Quality, Access, and Evaluation

Study Officials

• Stephanie Staras, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Staras, PhD

CONTACT

352-294-8299; sstaras@ufl.edu

Marta Hansen, MBA

CONTACT

352-627-9075; m.hansen1@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will test our hypotheses with a three-arm cluster randomized study design of nested strategies. Randomization will occur at the clinic level. All clinics will receive implementation strategy A: clinician-targeted recommendation training. A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids (B) for an implementation strategy package of A+B. Finally, a random half of the clinics who receive A+B will also receive community-targeted healthcare access (C) for a total implementation strategy package of A+B+C. This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone (A), 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids (A+B), and 10 clinics receive clinician-targeted recommendation training, parent-targeted motivational aids, and community-targeted healthcare access (A+B+C).

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once findings from the main study have been released.
• Access Criteria: Investigators will complete a data-sharing agreement and be charged a nonrefundable fee to cover administrative handling chargers and user support.

Locations

US (1)