Clinical trial NCT02835755: Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
Official title: Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-18
Enrollment: 150
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 pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine.

Detailed description: PRIMARY OBJECTIVES:

I. Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual men to establish feasibility and acceptability.

II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.

SECONDARY OBJECTIVES:

I. Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as the vaccine information statement (VIS), on a mobile-friendly website study portal.

GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail.

All patients complete a survey on the study portal at baseline, immediately after the mHealth intervention or control materials, and at 3 months and 7 months thereafter for about 10-15 minutes each.

Eligibility criteria: Inclusion Criteria:

* Self-identifies as gay or bisexual
* Lives in the United States (US)
* Has not received any doses of HPV vaccine

Primary outcomes:
measure: Acceptability will be established by examining participant satisfaction with study materials
timeFrame: Up to 7 months
measure: Feasibility established by achieving recruitment, retention, and medical record release goals
timeFrame: Up to 7 months
measure: Receipt of 1 or more doses of HPV vaccine
timeFrame: Up to 7 months
Secondary outcomes:
measure: Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)
timeFrame: Up to 7 months
measure: Receipt of second and third doses of HPV vaccine
timeFrame: Up to 7 months
Other outcomes:
Locations:
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, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. Increasing Human Papillomavirus Vaccination Among Young Gay and Bisexual Men: A Randomized Pilot Trial of the Outsmart HPV Intervention. LGBT Health. 2018 Jul;5(5):325-329. doi: 10.1089/lgbt.2018.0059.
citation: McRee AL, Shoben A, Bauermeister JA, Katz ML, Paskett ED, Reiter PL. Outsmart HPV: Acceptability and short-term effects of a web-based HPV vaccination intervention for young adult gay and bisexual men. Vaccine. 2018 Dec 18;36(52):8158-8164. doi: 10.1016/j.vaccine.2018.01.009. Epub 2018 Jan 10.