HPV Vaccine Intervention for Young Sexual Minority Men

The Ohio State University

Status: Completed

Conditions: Healthy Subject

Treatments: Other: Best Practice; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04032106

NCI-2019-01223 (Registry Identifier)

R37CA226682 (U.S. NIH Grant/Contract)

OSU-19028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,227 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,227 participants in 3 patient groups

Group A (standard HPV information)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Group B (Outsmart HPV, unidirectional vaccine reminders)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention

Behavioral: Text Message-Based Intervention

Behavioral: Text Message-Based Intervention

Other: Questionnaire Administration

Group C (Outsmart HPV, interactive vaccine reminders)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention

Behavioral: Text Message-Based Intervention

Behavioral: Text Message-Based Intervention

Other: Questionnaire Administration