Healthy Subject Clinical Trial
Official title:
A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
Verified date | May 2024 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
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 |
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