HPV Vaccine Intervention for Young Sexual Minority Men

NCT04032106 | Completed Results DMC

• 3 other identifiers: OSU-19028NCI-2019-01223R37CA226682
• Study Type: interventional
• Target: 1,227
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Subject

Keywords

HPV; Men; Vaccine

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Group A (standard HPV information)

ACTIVE COMPARATOR

Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.

Other: Best Practice; Other: Questionnaire Administration

Group B (Outsmart HPV, unidirectional vaccine reminders)

EXPERIMENTAL

Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).

Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention

Group C (Outsmart HPV, interactive vaccine reminders)

EXPERIMENTAL

Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention

Interventions

Best Practice OTHER

Receive standard information about HPV and HPV vaccine

Also known as: standard of care, standard therapy

Group A (standard HPV information)

Informational Intervention OTHER

Receive Outsmart HPV intervention

Group B (Outsmart HPV, unidirectional vaccine reminders); Group C (Outsmart HPV, interactive vaccine reminders)

Questionnaire Administration OTHER

Ancillary studies

Group A (standard HPV information); Group B (Outsmart HPV, unidirectional vaccine reminders); Group C (Outsmart HPV, interactive vaccine reminders)

Text Message-Based Intervention BEHAVIORAL

Receive unidirectional text message vaccine reminders

Group B (Outsmart HPV, unidirectional vaccine reminders)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Cisgender male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Marshall DJ, Gower AL, Katz ML, Bauermeister JA, Shoben AB, Reiter PL. Recruitment of Young Gay, Bisexual, and Other Men Who Have Sex With Men for a Web-Based Human Papillomavirus Vaccination Intervention: Differences in Participant Characteristics and Study Engagement by Recruitment Source in a Randomized Controlled Trial. J Med Internet Res. 2025 Jan 3;27:e64668. doi: 10.2196/64668.

  PMID: 39752644 DERIVED

• 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.

  PMID: 32130192 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr. Paul Reiter
• Organization: Ohio State University

reiter.36@osu.edu

614-292-4803

Study Officials

• Paul Reiter, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of the research questions being tested in the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 25, 2019
• Study Start: October 3, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 31, 2022
• Last Updated: March 14, 2025
• Results First Posted: May 6, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)