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Active, Not Recruiting

NCT Number: NCT04452526

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus-Related Malignant Neoplasm Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Educational Intervention

Other

Receive educational materials

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Reminder

Other

Receive reminder letter

Primary outcomes

  1. Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds

    Time frame: Baseline up to 24 months

    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.

  2. Change in rate of HPV vaccination initiation among those 13-26

    Time frame: Baseline up to 24 months

    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.

  3. Sustainability

    Time frame: Up to 24 months

    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.

  4. Cost-effectiveness

    Time frame: Up to 60 months

    Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.

  5. Change in knowledge of providers

    Time frame: Baseline up to 60 months

    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.

  6. Change in attitudes of providers

    Time frame: Baseline up to 60 months

    Will compare changes in attitudes of providers via educational session pre-post survey.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: IVaccinate

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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