Clinical trial NCT04032106: HPV Vaccine Intervention for Young Sexual Minority Men
Official title: A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Keywords: HPV
Men
Vaccine
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-25
Enrollment: 1227
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Human Papillomavirus (HPV) Vaccine Initiation and Completion
timeFrame: Baseline up to 9 months
measure: Changes in Theoretical Constructs
timeFrame: Baseline up to 9 months
measure: Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
timeFrame: Baseline up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Paul Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.