HPV Vaccine Reminder Intervention for Healthy Young Men

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help young men who identify as gay, bisexual, or queer begin and complete their HPV vaccinations. The study compares standard vaccine information with the "Outsmart HPV" intervention, which sends personalized vaccine reminders via mobile devices. Participants will receive either interactive reminders, non-interactive reminders, or just standard information. Men aged 18-25 in the U.S. who have not yet started the HPV vaccine and identify as part of the sexual minority community are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to innovative strategies that could improve vaccination rates in their community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing HPV vaccine uptake, so it's unlikely that your current medications will be affected.

What prior data suggests that the Outsmart HPV intervention is safe?

Research has shown that the Outsmart HPV program has been well-received in past studies. This online tool aims to boost HPV vaccination rates among young men who are attracted to other men or identify as gay, bisexual, or queer. Studies have found that the program is not only effective but also well-liked by participants. No major reports of negative effects have emerged from using Outsmart HPV, suggesting it is a safe choice for those considering joining a clinical trial for this program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost HPV vaccination rates among young men. The Outsmart HPV intervention is unique in that it uses interactive and unidirectional reminders to engage participants. Unlike traditional methods that simply provide information, these reminders can either encourage interaction or offer a straightforward alert, potentially improving vaccination compliance. By testing these innovative reminder techniques, researchers hope to discover more effective strategies for increasing vaccine uptake, ultimately reducing HPV-related health issues.

What evidence suggests that the Outsmart HPV intervention is effective for increasing HPV vaccine initiation and completion?

This trial will compare different approaches to increasing HPV vaccination rates among young males. Participants will be divided into groups receiving different interventions. Research has shown that the Outsmart HPV program, which some participants may receive, is a promising way to increase HPV vaccination rates among young males in the sexual minority group. In earlier studies, 33% of participants who received reminders started the HPV vaccine series, and 7% completed it. The program offers personalized information and reminders, which may help more people get vaccinated. In this trial, some participants will receive interactive reminders, while others will receive one-way reminders. Both types of reminders have proven equally effective in promoting vaccination. Early results suggest that this method could lead to more widespread HPV vaccine coverage in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Paul Reiter

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10239352/

Efficacy of the Outsmart HPV Intervention: A Randomized ... Outsmart HPV is a promising tool for increasing HPV vaccination among YGBMSM with the potential for wide dissemination.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6034390/

A Randomized Pilot Trial of the Outsmart HPV Intervention The study purpose was to pilot test a web-based human papillomavirus (HPV) vaccination intervention among young gay and bisexual men (YGBM).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02835755

Mobile Health Intervention in Increasing HPV Vaccine ... This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520301236

Interventions to increase uptake of Human Papillomavirus ... This systematic review assesses the effectiveness of interventions to increase HPV vaccine uptake, measured as vaccine series initiation and series completion.

5. experts.umn.edu experts.umn.edu/en/publications/efficacy-of-the-outsmart-hpv-intervention-a-randomized-controlled

Efficacy of the Outsmart HPV Intervention: A Randomized ... Regression models compared study groups on HPV vaccination outcomes. Results: Overall, 33% of participants reported initiating the HPV vaccine ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2022.2114261

Effects of a web-based HPV vaccination intervention on ... Outsmart HPV is a promising tool for improving key cognitive antecedents to HPV vaccination among YGBMSM, supporting the use of theoretically-informed ...

7. researchprotocols.org researchprotocols.org/2020/2/e16294/

A Web-Based Human Papillomavirus Vaccination ... The monthly vaccination reminders for the Out-U group will be unidirectional, meaning that participants will not have the option to respond to ...

8. mdpi.com mdpi.com/2076-393X/11/4/872

Using Electronic Reminders to Improve Human ... This work supports previous findings that electronic reminders are effective at increasing immunizations and potentially decreasing healthcare costs.