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NCT06535139 · ClinicalTrials.gov registry record · NA
ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention
A NA study of Papillomavirus Vaccines, sponsored by University of Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 4,630
- Enrollment target
- 1
- Study location
NCT06535139 is a NA study of Papillomavirus Vaccines that is actively recruiting participants, run by University of Florida. The registered enrollment target is 4,630 participants, above the 2,754-participant average among 4 other Papillomavirus Vaccines trials with a reported enrollment target (68% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06535139, a NA study of Papillomavirus Vaccines, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 4,630 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Brief training
- BEHAVIORAL Parent-targeted motivational aids
- BEHAVIORAL Healthcare access
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,630 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06535139
The ClinicalTrials.gov registry entry for NCT06535139 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 4,630 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,754-participant average among 4 other Papillomavirus Vaccines trials with a reported enrollment target (68% higher). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Papillomavirus Vaccines appearing as the primary indexed condition, and to 3 interventions - of which Brief training is the first listed.
NCT06535139 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06535139 about?
NCT06535139 is a clinical study titled "ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention". 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-...
What is the current status of trial NCT06535139?
This trial is currently recruiting. It is a NA study. The enrollment target is 4,630 participants. The study started on 2024-12-09. Estimated completion is 2027-07-01.
What conditions does trial NCT06535139 study?
This clinical trial studies the following conditions: Papillomavirus Vaccines.
What interventions are being tested in trial NCT06535139?
The interventions under investigation include: Brief training (BEHAVIORAL), Parent-targeted motivational aids (BEHAVIORAL), Healthcare access (BEHAVIORAL).
Who is sponsoring clinical trial NCT06535139?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06535139 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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