HPV Vaccine Intervention for Young Sexual Minority Men

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Informational Intervention; Behavioral: Text Message-Based Intervention; Behavioral: Text Message-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (standard HPV information); Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard information about HPV and HPV vaccine; Other Names: standard of care; standard therapy
Experimental: Group B (Outsmart HPV, unidirectional vaccine reminders); Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive Outsmart HPV intervention; Behavioral: Text Message-Based Intervention; Receive unidirectional text message vaccine reminders; Behavioral: Text Message-Based Intervention; Receive interactive text message vaccine reminders
Experimental: Group C (Outsmart HPV, interactive vaccine reminders); Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive Outsmart HPV intervention; Behavioral: Text Message-Based Intervention; Receive unidirectional text message vaccine reminders; Behavioral: Text Message-Based Intervention; Receive interactive text message vaccine reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papillomavirus (HPV) Vaccine Initiation and Completion	Number and proportion of participants who initiate and complete the HPV vaccine series during the study period	Baseline up to 9 months
Changes in Theoretical Constructs	Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change.	Baseline up to 9 months
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics	Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys	Baseline up to 9 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Reiter PL, Gower AL, Kiss DE, Malone MA, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. 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 Res Protoc. 2020 Feb 24;9(2):e16294. doi: 10.2196/16294.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; HPV; Men
• Other Study ID Numbers: OSU-19028; NCI-2019-01223 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R37CA226682 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No