Study Summary
This trial will study how well a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders works in increasing HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Baseline up to 9 months
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Group A (standard HPV information)
1 of 3
Group B (Outsmart HPV, unidirectional vaccine reminders)
1 of 3
Group C (Outsmart HPV, interactive vaccine reminders)
1 of 3
Active Control
Experimental Treatment
158 Total Participants · 3 Treatment Groups
Primary Treatment: Informational Intervention · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 25 · Male Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Ohio | 50.0% |
| New Mexico | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
What site did they apply to?
| Ohio State University Comprehensive Cancer Center | 100.0% |
- Reiter, Paul L, Amy L Gower, Dale E Kiss, Molly A Malone, Mira L Katz, Jose A Bauermeister, Abigail B Shoben, Electra D Paskett, and Annie-Laurie McRee. 2020. “A Web-based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex with Men: Protocol for a Randomized Controlled Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/16294.
- Paul Reiter 2019. "HPV Vaccine Intervention for Young Sexual Minority Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04032106.
Frequently Asked Questions
Does my eligibility meet the criteria for inclusion in this investigation?
"This clinical trial seeks 158 volunteers aged 18 to 25 who identify as cisgender male, sexual minority (having had intimate interactions with males or being attracted to them; or identifying as gay, bisexual, queer), residing in the USA and have not previously been vaccinated for HPV. Additionally, these candidates must be literate in English and capable of providing informed approval by completing a screener survey and consent form." - Anonymous Online Contributor
Is the age range for recruitment on this study inclusive of those over 20 years old?
"This clinical trial is strictly for people between 18 and 25 years old. Conversely, there are 50 studies that cater to minors and 371 trials dedicated towards senior citizens." - Anonymous Online Contributor
Is this research protocol still recruiting participants?
"According to the information housed on clinicaltrials.gov, this research has achieved its patient quota and is no longer recruiting; however, 839 other studies are still searching for volunteers at current. This trial was initially posted in October of 2019 with a final update occurring in September 2022." - Anonymous Online Contributor