N/A
N=1,227
HPV Vaccine Intervention for Young Sexual Minority Men
Healthy Subject
Bottom Line
View on ClinicalTrials.gov: NCT04032106 ↗Enrolled (actual)
1,227
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Human Papillomavirus (HPV) Vaccine Initiation and Completion — 114; 139; 147; 298 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Best Practice (Other); Informational Intervention (Other); Questionnaire Administration (Other); Text Message-Based Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Papillomavirus (HPV) Vaccine Initiation and Completion |
114; 139; 147; 298; 268; 261 | — |
| PRIMARY Changes in Theoretical Constructs |
-0.04; 0.01; -0.09; 0.41; 0.58; 0.50 | — |
| PRIMARY Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics |
41; 53; 46; 73; 86; 101 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04032106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.