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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Carcinoma, Human Papillomavirus-Related Malignant Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Other: Educational Intervention
* Other: Questionnaire Administration
* Other: Reminder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM I (EARLY INTERVENTION) (educational material, reminders)<br>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 | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Reminder<br>* Receive reminder letter<br>|
| Experimental: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)<br>Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Reminder<br>* Receive reminder letter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in attitudes of providers | Will compare changes in attitudes of providers via educational session pre-post survey. | Baseline up to 60 months |