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HPV Vaccine Intervention for Young Sexual Minority Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032106
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul Reiter, Ohio State University Comprehensive Cancer Center

Brief Summary:
This phase III trial studies how well the Outsmart HPV intervention works in increasing HPV vaccine initiation and completion among young individuals who report having a history of same-sex partners, being sexually attracted to males, or identify as gay, bisexual, or queer (i.e., sexual minority males). The Outsmart HPV intervention, which is a population-targeted, individually-tailored mHealth intervention that includes vaccine reminders, may increase HPV vaccine initiation and completion among unvaccinated young sexual minority individuals.

Condition or disease Intervention/treatment Phase
Healthy Subject Other: Best Practice Other: Informational Intervention Other: Questionnaire Administration Behavioral: Text Message-Based Intervention Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the efficacy of the Outsmart HPV intervention on increasing HPV vaccine initiation and completion.

II. Identify mediators that explain the relationship between study arm and HPV vaccine initiation and completion.

III. Determine if intervention efficacy differs across key demographic and health-related characteristics of participants.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP A: Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.

GROUP B: Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).

GROUP C: Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Participants in all study group are followed for 9 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1995 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants are not aware of the research questions being tested in the trial.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A (standard HPV information)
Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Other: Best Practice
Receive standard information about HPV and HPV vaccine
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies

Experimental: Group B (Outsmart HPV, unidirectional vaccine reminders)
Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Other: Informational Intervention
Receive Outsmart HPV intervention

Other: Questionnaire Administration
Ancillary studies

Behavioral: Text Message-Based Intervention
Receive unidirectional text message vaccine reminders

Experimental: Group C (Outsmart HPV, interactive vaccine reminders)
Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).
Other: Informational Intervention
Receive Outsmart HPV intervention

Other: Questionnaire Administration
Ancillary studies

Behavioral: Text Message-Based Intervention
Receive interactive text message vaccine reminders




Primary Outcome Measures :
  1. Human papillomavirus (HPV) vaccine initiation and completion [ Time Frame: Baseline up to 9 months ]
    Number and proportion of participants who initiate and complete the HPV vaccine series during the study period

  2. Changes in theoretical constructs [ Time Frame: Baseline up to 9 months ]
    Changes in theoretical constructs from baseline to follow-up timepoints as assessed by study surveys

  3. Potential moderators [ Time Frame: Baseline up to 9 months ]
    Demographic and health-related characteristics as assessed by study surveys



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cisgender male
  • Ages 18-25
  • Sexual minority (reports ever having oral or anal sex with a male or being sexually attracted to males; or identifies as gay, bisexual, or queer)
  • Lives in the United States (US)
  • Has not received any doses of HPV vaccine
  • Did not participate in the pilot study
  • Read English
  • Able to provide informed consent (inferred by completing the screener survey and consent form)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032106


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Annie-Laurie McRee, PhD    612-626-0162    almcree@umn.edu   
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Paul Reiter    614-292-4803    reiter.36@osu.edu   
Principal Investigator: Paul Reiter         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Paul Reiter, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Paul Reiter, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04032106    
Other Study ID Numbers: OSU-19028
NCI-2019-01223 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
R37CA226682 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Reiter, Ohio State University Comprehensive Cancer Center:
HPV
Men
Vaccine
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs