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Completed

NCT Number: NCT04032106

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.

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Key information

Conditions

Healthy Subject Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Best Practice

Other

Receive standard information about HPV and HPV vaccine

Other names: standard of care, standard therapy

Informational intervention

Other

Receive Outsmart HPV intervention

Questionnaire Administration

Other

Ancillary studies

Text message-based intervention

Behavioral

Receive unidirectional text message vaccine reminders

Primary outcomes

  1. Human Papillomavirus (HPV) Vaccine Initiation and Completion

    Time frame: Baseline up to 9 months

    Number and proportion of participants who initiate and complete the HPV vaccine series during the study period

  2. Changes in Theoretical Constructs

    Time frame: 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.

  3. Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics

    Time frame: Baseline up to 9 months

    Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2019
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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