I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
Purpose
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.
Conditions
- Cervical Carcinoma
- Human Papillomavirus-Related Malignant Neoplasm
Eligibility
- Eligible Ages
- Over 11 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ARM I (EARLY INTERVENTION) (educational material, reminders) |
Health systems receive educational materials consisting of posters, brochures and handouts. 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 |
|
|
Experimental ARM II (DELAYED INTERVENTION)(education, reminder, usual care) |
Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT04452526
- Status
- Recruiting
- Sponsor
- Ohio State University Comprehensive Cancer Center
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.