PREVENT Pilot HPV - Related Cancers Trial

Utah System of Higher Education (USHE)

Status: Completed

Conditions: HPV Vaccination; Series Completion; Uptake Vaccination

Treatments: Behavioral: PREVENT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06738355

DSS_10065815 (Other Identifier)

HCI161649-2

1R01CA279973-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 populations in the United States.

The proposed study will assess the feasibility of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington.

Full description

This is a randomized, pilot study two human papillomavirus (HPV) vaccination patient reminder intervention arms that will take place in rural clinics operated by Sea Mar Community Health Centers.

The PREVENT PILOT study will administer a three-arm, patient-randomized controlled trial that will assess the feasibility of clinic-based outreach to increase vaccination rates. The study arms will consist of automated reminders, automated plus live reminders, and usual care. Parents/caregivers of children and adolescents selected for the trial will be chosen using established study criteria applied to the electronic health records linked to state immunization registries. As a minimal-risk study, for the intervention only, the investigators will apply for a waiver of informed consent. The PILOT study will be delivered as part of standard care, and patients will be unaware they are in the trial. Delivered vaccination messages will include opt-out choices.

Parents/caregivers (P/C) of children and adolescents (C/A) will be sent any number of reminders to encourage parents to obtain an HPV vaccine for their age-eligible C/A. Reminders may include text messages, automated phone calls, mailed letters, live calls, or patient navigation. Reminders will be delivered by a vendor (automated reminders) or clinic staff (live reminders). Reminders will be delivered in English and Spanish, and interpreter services may be used for live reminders to the small proportion of patients who speak languages other than English or Spanish.

The primary objective of this pilot study is the feasibility of the trial, which will be assessed by the number of patients randomized to the study intervention. Other secondary outcome measures include the correctness of the randomization, successful receipt of a text message intervention, the proportion of participants who responded to the text intervention, and the proportion of participants who were successfully contacted.

During active study recruitment, the investigators will convene a meeting of our data safety monitor board every six months. The investigators will disseminate study findings and research products in accordance with our dissemination plan. The study findings will serve as a basis for a larger multi-level trial of HPV vaccination in rural communities.

Enrollment: 519 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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519 participants in 3 patient groups

Automated Intervention (Auto)

Experimental group

Description:

Auto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours.

Treatment:

Behavioral: PREVENT

Automated Intervention Plus (Auto-Plus)

Experimental group

Description:

Auto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Activities selected from a list of possible options from the National HPV Vaccination Roundtable and our ranking of the effectiveness of language- and culturally-tailored intervention materials.

Treatment:

Behavioral: PREVENT

Usual Care (UC)

No Intervention group

Description:

The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders.