HPV Vaccine Intervention for Young Sexual Minority Men (NCT04032106) | Clinical Trial Compass
CompletedNot Applicable
HPV Vaccine Intervention for Young Sexual Minority Men
United States1,227 participantsStarted 2019-10-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 25 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cisgender male
* Ages 18-25
* Sexual minority (reports ever having oral or anal sex with a male or being sexually attracted to males; or identifies as gay, bisexual, or queer)
* Lives in the United States (US)
* Has not received any doses of HPV vaccine
* Did not participate in the pilot study
* Read English
* Able to provide informed consent (inferred by completing the screener survey and consent form)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Human Papillomavirus (HPV) Vaccine Initiation and Completion
Timeframe: Baseline up to 9 months
2
Changes in Theoretical Constructs
Timeframe: Baseline up to 9 months
3
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Timeframe: Baseline up to 9 months
Trial details
NCT IDNCT04032106
SponsorOhio State University Comprehensive Cancer Center