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

The Ohio State University

Status: Completed

Conditions: Healthy Subject

Treatments: Other: Educational Intervention; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02835755

OSU-15234

R21CA194831 (U.S. NIH Grant/Contract)

P30CA016058 (U.S. NIH Grant/Contract)

NCI-2016-00819 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group I (Control)

Active Comparator group

Description:

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

Treatment:

Other: Educational Intervention

Other: Survey Administration

Other: Educational Intervention

Group II (mHealth HPV vaccine)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Survey Administration

Other: Educational Intervention