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HPV Vaccine Intervention for Young Sexual Minority Men

NCT04032106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1227

Last updated 2025-03-14

Study results available
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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.

Conditions

  • Healthy Subject

Interventions

OTHER

Best Practice

Receive standard information about HPV and HPV vaccine

OTHER

Informational Intervention

Receive Outsmart HPV intervention

OTHER

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Text Message-Based Intervention

Receive unidirectional text message vaccine reminders

BEHAVIORAL

Text Message-Based Intervention

Receive interactive text message vaccine reminders

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Paul Reiter, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2022-03-30
Completion
2022-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032106 on ClinicalTrials.gov