Clinical trial NCT04452526: I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
Official title: Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Carcinoma
Human Papillomavirus-Related Malignant Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-30
Enrollment: 1500
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (HPV) vaccine initiation and completion among children in health systems in four Appalachian states. Utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the HPV vaccine in children and young adults, ultimately preventing the development of cervical cancer.

Detailed description: PRIMARY OBJECTIVE:

I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers, and patients (parents of children aged 11-12) to improve HPV vaccine initiation and completion in health systems in four Appalachian states (Kentucky \[KY\], Ohio \[OH\], West Virginia \[WV,\] and Virginia \[VA\]) among children aged 11-12 and assess the effectiveness of the intervention program among subgroups, e.g., females versus (vs) males.

SECONDARY OBJECTIVES:

I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention III. Assess changes in clinic practices that occur as a result of the intervention in terms of staff responsibilities for the vaccination process and reducing missed opportunities for vaccination.

IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.

V. Examine changes in knowledge and attitudes of providers via educational session pre-post surveys.

VI. Satisfaction with the intervention at the multiple levels.

OUTLINE: Health systems are randomized to 1 of 2 arms.

ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of posters, brochures and table tents. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination.

ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.

Eligibility criteria: Inclusion Criteria:

CLINIC

* Located in one of the counties that are part of this program
* Provides care to patients aged 11-26
* Provides immunizations

HEALTH CARE PROVIDERS (PHYSICIANS, NURSES) AND OFFICE STAFF

* Practicing in a clinic in one of the participating health systems
* Personnel involved in the vaccine process (determined by individual clinics)
* Able to speak, read, and write English

Primary outcomes:
measure: Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds
timeFrame: Baseline up to 24 months
measure: Change in rate of HPV vaccination initiation among those 13-26
timeFrame: Baseline up to 24 months
measure: Sustainability
timeFrame: Up to 24 months
measure: Cost-effectiveness
timeFrame: Up to 60 months
measure: Change in knowledge of providers
timeFrame: Baseline up to 60 months
measure: Change in attitudes of providers
timeFrame: Baseline up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky/Markey Cancer Center
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra D Paskett
role: PRINCIPAL_INVESTIGATOR
References: