PREVENT HPV-Related Cancers RCT

Not Applicable

Not yet recruiting

• Conditions: Vaccine Hesitancy; HPV Vaccination; Uptake Vaccination; Series Completion; Vaccine Refusal

• Registration Number: NCT06738355
• Lead Sponsor: University of Utah

Brief Summary

This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural popula...

Detailed Description

The clinical trial in the PREVENT study is a patient-randomized control trial (RCT) of two human papillomavirus (HPV) vaccination patient reminder intervention arms that will take place in rural clinics operated by Sea Mar Community Health Centers. Results from the BootCamp Translation (BCT) activities will be conducted in English and Spanish and will inform...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01-01
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

1. Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);
2. P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and
3. P/C who speak either English or Spanish.

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Exclusion Criteria

1. P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due);
2. P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy);
3. P/C of C/A with other factors that would influence CDC HPV recommendations; and
4. P/C that does not speak Spanish or English.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)	6 Months	The investigators will track intervention reach using the Proctor Implementation and RE-AIM frameworks. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 6 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logisti...

Secondary Outcome Measures

Name	Time	Method
RCT Arm Effectiveness: Next HPV Vaccination Step Completion	13 Months	The investigators will track intervention effectiveness using the Proctor Implementation and RE-AIM frameworks. The primary comparisons are the rates of completing the next step in the HPV vaccination series at 13 months (N C/A complete next HPV vaccine dose/ N anticipated) between the Auto, Auto-Plus, and UC arms. The investigators anticipate little missing...
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)	13 Months	Using the Proctor Implementation and RE-AIM frameworks, the investigators will track intervention reach. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 13 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logis...

Trial Locations

Locations (1)

Sea Mar Community Health Centers; 🇺🇸 Seattle, Washington, United States