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Cancer Vaccine

HPV Education for HPV

Phase 4

Recruiting

Led By Gerardo Colon-Otero, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For female patients, no history of positive HPV testing or abnormal Papanicolaou (Pap) smears

No history of HPV vaccination

Must not have

Individuals who had previously received the HPV vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at whether an educational program about HPV can increase the rates of HPV vaccination among low income uninsured adults, which may prevent HPV-related cancers.

Who is the study for?

This trial is for adults who have never had an HPV vaccine, no allergies to its contents, and women without a history of positive HPV tests or abnormal Pap smears. Participants must understand English, be patients at the VIM clinic, and willing to join the study. Those who've already received the HPV vaccine cannot participate.

What is being tested?

The trial is testing whether an educational program can increase acceptance and completion of free HPV vaccinations among underserved adults. It aims to boost vaccination rates in this group which may help prevent HPV-related cancers.

What are the potential side effects?

Since this trial involves an educational intervention rather than a medical treatment, there are no direct side effects from medications or vaccines as part of the study itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had a positive HPV test or abnormal Pap smear.

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I have never received the HPV vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received the HPV vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (HPV educational program)Experimental Treatment2 Interventions

Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.

0 / 3Eligibility criteria met