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OpenTrials
Completed

NCT Number: NCT02835755

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

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.

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Key information

Conditions

Healthy Subject

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Educational Intervention

Other

Receive standard HPV and HPV vaccine information

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Acceptability will be established by examining participant satisfaction with study materials

    Time frame: Up to 7 months

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

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

    Time frame: Up to 7 months

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

  3. Receipt of 1 or more doses of HPV vaccine

    Time frame: Up to 7 months

    Evaluated using logistic regression.

Secondary outcomes

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

    Time frame: Up to 7 months

    Evaluated using analysis of covariance models.

  2. Receipt of second and third doses of HPV vaccine

    Time frame: Up to 7 months

    Evaluated using logistic regression.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 18, 2016
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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