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

NCT ID: NCT02835755

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2017-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subject

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I (Control)

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

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Receive standard HPV and HPV vaccine information

Survey Administration

Intervention Type OTHER

Ancillary studies

Group II (mHealth HPV vaccine)

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive mHealth HPV vaccine intervention

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational Intervention

Receive standard HPV and HPV vaccine information

Intervention Type OTHER

Educational Intervention

Receive mHealth HPV vaccine intervention

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul Reiter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Reiter, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29979642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29331245 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2016-00819

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA016058

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA194831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-15234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Information Seeking About Pre-exposure Prophylaxis
NCT05728034 ACTIVE_NOT_RECRUITING NA