HPV Vaccine Reminder Intervention for Healthy Young Men

Recruiting at 1 trial location

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Received HPV vaccine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1227 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.

Research Team

Paul Reiter

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for young cisgender males aged 18-25 in the US who identify as gay, bisexual, or queer, have not had any HPV vaccine doses, and can give informed consent. Participants must be able to read English and should not have taken part in the pilot study.

Inclusion Criteria

I identify as part of the sexual minority, including gay, bisexual, or queer.

I am a cisgender male.

Did not participate in the pilot study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either standard HPV information or the Outsmart HPV intervention with vaccine reminders

9 months

Follow-up

Participants are monitored for changes in theoretical constructs and HPV vaccine initiation and completion

9 months

Treatment Details

Interventions

• Outsmart HPV intervention

Trial Overview The trial tests the 'Outsmart HPV' intervention designed to increase HPV vaccine uptake among sexual minority males. It includes personalized mobile health components like reminders to initiate and complete the vaccination process.

Participant Groups

Group I: Group C (Outsmart HPV, interactive vaccine reminders) Experimental Treatment 3 Interventions

Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Group II: Group B (Outsmart HPV, unidirectional vaccine reminders) Experimental Treatment 3 Interventions

Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).

Group III: Group A (standard HPV information) Active Control 2 Interventions

Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+