HPV Vaccine Intervention for Young Sexual Minority Men

Not Applicable

Completed

• Conditions: Healthy Subject
• Interventions: Other: Best Practice; Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention

• Registration Number: NCT04032106
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-25
• Study Start: 2019-10-03
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-31
• Results First Submitted: 2023-01-20
• Results First Submitted QC: 2023-05-03
• Results First Posted: 2023-05-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1227

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (standard HPV information)	Best Practice	Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Group B (Outsmart HPV, unidirectional vaccine reminders)	Questionnaire Administration	Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Group B (Outsmart HPV, unidirectional vaccine reminders)	Text Message-Based Intervention	Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Group A (standard HPV information)	Questionnaire Administration	Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Group B (Outsmart HPV, unidirectional vaccine reminders)	Informational Intervention	Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Group C (Outsmart HPV, interactive vaccine reminders)	Informational Intervention	Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Group C (Outsmart HPV, interactive vaccine reminders)	Questionnaire Administration	Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Group C (Outsmart HPV, interactive vaccine reminders)	Text Message-Based Intervention	Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Primary Outcome Measures

Name	Time	Method
Human Papillomavirus (HPV) Vaccine Initiation and Completion	Baseline up to 9 months	Number and proportion of participants who initiate and complete the HPV vaccine series during the study period
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics	Baseline up to 9 months	Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys
Changes in Theoretical Constructs	Baseline up to 9 months	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.

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States