HPV Vaccine Intervention for Young Sexual Minority Men

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04032106
• Other study ID #: OSU-19028
• Secondary ID: NCI-2019-01223R3
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1227
• Est. completion date: March 31, 2025
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• Best Practice
Receive standard information about HPV and HPV vaccine
• Informational Intervention
Receive Outsmart HPV intervention
• Questionnaire Administration
Ancillary studies

Behavioral:
• Text Message-Based Intervention
Receive unidirectional text message vaccine reminders
• Text Message-Based Intervention
Receive interactive text message vaccine reminders

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   The Jamesline