Clinical trial · Interventional
HPV Vaccine Intervention for Young Sexual Minority Men
A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Subject | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Text Message-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group A (standard HPV information)
- description
- Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
- interventionNames
- Other: Best Practice
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group B (Outsmart HPV, unidirectional vaccine reminders)
- description
- Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
- interventionNames
- Other: Informational Intervention
- Other: Questionnaire Administration
- Behavioral: Text Message-Based Intervention
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDMarshall DJ, Gower AL, Katz ML, Bauermeister JA, Shoben AB, Reiter PL. Recruitment of Young Gay, Bisexual, and Other Men Who Have Sex With Men for a Web-Based Human Papillomavirus Vaccination Intervention: Differences in Participant Characteristics and Study Engagement by Recruitment Source in a Randomized Controlled Trial. J Med Internet Res. 2025 Jan 3;27:e64668. doi: 10.2196/64668. PMID 39752644
- DERIVEDReiter PL, Gower AL, Kiss DE, Malone MA, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 24;9(2):e16294. doi: 10.2196/16294. PMID 32130192