NCT04032106

HPV Vaccine Intervention for Young Sexual Minority Men

A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,227 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion. II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion. III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants. OUTLINE: Participants are randomized to 1 of 3 groups. GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). Participants in all study group are followed for 9 months.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard information about HPV and HPV vaccine
OTHER	Informational Intervention	Receive Outsmart HPV intervention
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Text Message-Based Intervention	Receive unidirectional text message vaccine reminders
BEHAVIORAL	Text Message-Based Intervention	Receive interactive text message vaccine reminders

Timeline

• Start date: 2019-10-03
• Primary completion: 2022-03-30
• Completion: 2022-03-31
• First posted: 2019-07-25
• Last updated: 2025-03-14
• Results posted: 2023-05-06

Locations

2 sites across 1 country: United States