Cervical CarcinomaIVaccinateNCT04452526
I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
A study testing Best Practice, Educational Intervention and Questionnaire Administration in people with Cervical Carcinoma and Human Papillomavirus-Related Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus-Related Malignant Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Questionnaire Administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Oct 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
- Being tested
- Best Practice, Educational Intervention, Questionnaire Administration, Reminder
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
Questionnaire AdministrationOther
Ancillary studies
ReminderOther
Receive reminder letter
| Study group | Role | What they receive |
|---|---|---|
| ARM I (EARLY INTERVENTION) (educational material, reminders) | Experimental | 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 Receives: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Reminder |
| ARM II (DELAYED INTERVENTION)(education, reminder, usual care) | Experimental | Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I. Receives: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 60 months
Change in attitudes of providers
Will compare changes in attitudes of providers via educational session pre-post survey.
Measured: Baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start21 Oct 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D Paskett, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452526
- Sponsor's protocol ID
- OSU-20058
- Other IDs
- NCI-2020-01225, P01CA229143
- Acronym
- IVaccinate
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program
- ClinicalTrials.gov ID
- NCT04452526
- Acronym / sponsor ID
- IVaccinate / OSU-20058
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (EARLY INTERVENTION) (educational material, reminders) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire Administration, Other: ReminderHealth 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 |
| ARM II (DELAYED INTERVENTION)(education, reminder, usual care) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire Administration, Other: ReminderHealth systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | ARM I (EARLY INTERVENTION) (educational material, reminders), ARM II (DELAYED INTERVENTION)(education, reminder, usual care) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials | Other | ARM I (EARLY INTERVENTION) (educational material, reminders), ARM II (DELAYED INTERVENTION)(education, reminder, usual care) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (EARLY INTERVENTION) (educational material, reminders), ARM II (DELAYED INTERVENTION)(education, reminder, usual care) |
| ReminderReceive reminder letter | Other | ARM I (EARLY INTERVENTION) (educational material, reminders), ARM II (DELAYED INTERVENTION)(education, reminder, usual care) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra D Paskett principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Questionnaire Administration in people with Cervical Carcinoma and Human Papillomavirus-Related Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds (time frame: Baseline up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.