NCT02835755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

July 13, 2016

Last Update Submit

August 1, 2017

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (3)

  • Acceptability will be established by examining participant satisfaction with study materials

    Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.

    Up to 7 months

  • Feasibility established by achieving recruitment, retention, and medical record release goals

    Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05

    Up to 7 months

  • Receipt of 1 or more doses of HPV vaccine

    Evaluated using logistic regression.

    Up to 7 months

Secondary Outcomes (2)

  • Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)

    Up to 7 months

  • Receipt of second and third doses of HPV vaccine

    Up to 7 months

Study Arms (2)

Group I (Control)

ACTIVE COMPARATOR

Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal.

Other: Educational InterventionOther: Survey Administration

Group II (mHealth HPV vaccine)

EXPERIMENTAL

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.

Other: Educational InterventionOther: Survey Administration

Interventions

Educational InterventionOTHER

Receive standard HPV and HPV vaccine information

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Group I (Control)
Survey AdministrationOTHER

Ancillary studies

Group I (Control)Group II (mHealth HPV vaccine)

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • 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.

    PMID: 29979642DERIVED

  • 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.

    PMID: 29331245DERIVED

Related Links

MeSH Terms

Interventions

Early Intervention, EducationalEducational StatusMethods

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Paul Reiter, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 18, 2016

Study Start

July 11, 2016

Primary Completion

September 8, 2016

Study Completion

April 16, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

US(1)