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NCT02835755 Clinical Trial

Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men

Healthy Subject Clinical Trial

Official title:
Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02835755
Other study ID # OSU-15234
Secondary ID NCI-2016-00819P3
Status Completed
Phase N/A
First received July 13, 2016
Last updated August 1, 2017
Start date July 11, 2016
Est. completion date April 16, 2017

Study information
Verified date August 2017
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 16, 2017
Est. primary completion date September 8, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Self-identifies as gay or bisexual

- Lives in the United States (US)

- Has not received any doses of HPV vaccine

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Educational Intervention
Receive standard HPV and HPV vaccine information
• Educational Intervention
Receive mHealth HPV vaccine intervention
• Survey Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

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 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
Primary 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
Primary Receipt of 1 or more doses of HPV vaccine Evaluated using logistic regression. Up to 7 months
Secondary Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge) Evaluated using analysis of covariance models. Up to 7 months
Secondary Receipt of second and third doses of HPV vaccine Evaluated using logistic regression. Up to 7 months
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