NCT04452526

I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination

Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Carcinoma
• Human Papillomavirus-Related Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Educational Intervention	Receive educational materials
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Reminder	Receive reminder letter

Timeline

• Start date: 2020-10-21
• Primary completion: 2025-06-26
• Completion: 2025-09-01
• First posted: 2020-06-30
• Last updated: 2025-08-26

Locations

4 sites across 1 country: United States