ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06535139
Status
Recruiting
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Conditions

  • Papillomavirus Vaccines

Eligibility Criteria

Sex
ALL
Age
8 Years - 99 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
Dec 9, 2024
Status verified
Sep 2025
Primary completion
May 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
4,630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Clinician-targeted training
    All clinicians and nurses will be assigned to participate in a training on how to recommend or discuss the HPV vaccine.
  • Experimental: Clinician-targeted training and Parent-targeted motivational aids
    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.
  • Experimental: Clinician-targeted training, Parent-targeted motivational aids, and Healthcare Access
    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.

Primary Outcome Measure

Initiation of the HPV Vaccine [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608-

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By research site
University of Florida· Gainesville, FL

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