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

Cervical Carcinoma Clinical Trial

— IVaccinate  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452526
• Other study ID #: OSU-20058
• Secondary ID: NCI-2020-01225P0
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Carcinoma
• Human Papillomavirus-Related Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Educational Intervention
Receive educational materials
• Questionnaire Administration
Ancillary studies
• Reminder
Receive reminder letter

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds	The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.	Baseline up to 24 months
Primary	Change in rate of HPV vaccination initiation among those 13-26	The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.	Baseline up to 24 months
Primary	Sustainability	Will use logistic regression models with random health systems effects to compare odds of vaccination at the end of sustainability period to odds of vaccination at the end of the implementation period.	Up to 24 months
Primary	Cost-effectiveness	Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.	Up to 60 months
Primary	Change in knowledge of providers	Will compare changes in knowledge of providers via educational session pre-post survey. Changes in Knowledge following the educational session will be assessed using linear mixed models containing random health system effects.	Baseline up to 60 months
Primary	Change in attitudes of providers	Will compare changes in attitudes of providers via educational session pre-post survey.	Baseline up to 60 months

External Links

•   The Jamesline