Healthy SubjectNCT04032106

HPV Vaccine Intervention for Young Sexual Minority Men

A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Healthy Subject, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subject
What is being tested?: Best Practice, Informational Intervention and Questionnaire Administration
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,227 participants
Where: 2 sitesUnited States
Study dates: 3 Oct 2019to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men

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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Healthy Subject
Being tested: Best Practice, Informational Intervention, Questionnaire Administration, Text Message-Based Intervention
Keywords: HPV, Men, Vaccine
Medical subject headings: Multiple Endocrine Neoplasia Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive standard information about HPV and HPV vaccine
Informational InterventionOther
Receive Outsmart HPV intervention
Questionnaire AdministrationOther
Ancillary studies
Text Message-Based InterventionBehavioural
Receive unidirectional text message vaccine reminders
Text Message-Based InterventionBehavioural
Receive interactive text message vaccine reminders

Study groups in NCT04032106
Study group	Role	What they receive
Group A (standard HPV information)	Active comparator	Participants receive standard information about HPV and HPV vaccine via a mobile-friendly website. Receives: Other: Best Practice; Other: Questionnaire Administration
Group B (Outsmart HPV, unidirectional vaccine reminders)	Experimental	Participants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond). Receives: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention
Group C (Outsmart HPV, interactive vaccine reminders)	Experimental	Participants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond). Receives: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Text Message-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Human Papillomavirus (HPV) Vaccine Initiation and Completion
Number and proportion of participants who initiate and complete the HPV vaccine series during the study period
Measured: Baseline up to 9 months
Changes in Theoretical Constructs
Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change.
Measured: Baseline up to 9 months
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys
Measured: Baseline up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201931 Mar 2022

First posted25 Jul 2019
Study start3 Oct 2019
Primary completion30 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04032106
Sponsor's protocol ID: OSU-19028
Other IDs: NCI-2019-01223, R37CA226682
Status last verified: Mar 2025
First submitted: 22 Jul 2019
Last updated: 14 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Marshall 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.
PubMed 39752644
Reiter 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.
PubMed 32130192

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of an HPV Vaccine Intervention for Young Sexual Minority Men
ClinicalTrials.gov ID: NCT04032106
Acronym / sponsor ID: OSU-19028
Conditions: Healthy Subject
Keywords: HPV, Men, Vaccine
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,227 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 3 Oct 2019 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 25 Jul 2019 (actual)
Results: Posted 6 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Group A (standard HPV information)	Active comparator	Other: Best Practice, Other: Questionnaire AdministrationParticipants receive standard information about HPV and HPV vaccine via a mobile-friendly website.
Group B (Outsmart HPV, unidirectional vaccine reminders)	Experimental	Other: Informational Intervention, Other: Questionnaire Administration, Behavioral: Text Message-Based InterventionParticipants receive Outsmart HPV with unidirectional vaccine reminders (i.e. reminders that do not give participants the option to respond).
Group C (Outsmart HPV, interactive vaccine reminders)	Experimental	Other: Informational Intervention, Other: Questionnaire Administration, Behavioral: Text Message-Based InterventionParticipants receive Outsmart HPV with interactive vaccine reminders (i.e. reminders that allow participants to respond).

Who may qualify

Ages: 18 to 25 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Best PracticeAlso: standard of care, standard therapyReceive standard information about HPV and HPV vaccine	Other	Group A (standard HPV information)
Informational InterventionReceive Outsmart HPV intervention	Other	Group B (Outsmart HPV, unidirectional vaccine reminders), Group C (Outsmart HPV, interactive vaccine reminders)
Questionnaire AdministrationAncillary studies	Other	Group A (standard HPV information), Group B (Outsmart HPV, unidirectional vaccine reminders), Group C (Outsmart HPV, interactive vaccine reminders)
Text Message-Based InterventionReceive unidirectional text message vaccine reminders	Behavioural	Group B (Outsmart HPV, unidirectional vaccine reminders)
Text Message-Based InterventionReceive interactive text message vaccine reminders	Behavioural	Group C (Outsmart HPV, interactive vaccine reminders)

Primary outcome

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
Changes in Theoretical Constructs
Time frame: Baseline up to 9 months
Changes in theoretical constructs from baseline to follow-up as assessed by study surveys. Survey items developed by the study team were used to assess changes in perceived severity of HPV-related disease (possible range of -3 to 3), response efficacy of HPV vaccine (possible range of -4 to 4), and worry about getting HPV-related disease (possible range of -3 to 3). The reported numbers represent the mean change for each construct that occurred from baseline to follow-up. For each construct, a score of 0 represents no change between survey timepoints. Change scores greater than 0 indicate an increase in that construct between survey timepoints, with more positive values indicating a greater amount of change. Change scores less than 0 indicate an decrease in that construct between survey timepoints, with more negative values indicating a greater amount of change.
Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics
Time frame: Baseline up to 9 months
Counts of human papillomavirus (HPV) vaccine initiation by demographic and health-related characteristics as assessed by study surveys

Results and safety

Results posted to the registry on 6 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (Standard HPV Information)	412	295
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)	407	271
Group C (Outsmart HPV, Interactive Vaccine Reminders)	408	276

Primary outcome: Human Papillomavirus (HPV) Vaccine Initiation and Completion

Time frame: Baseline up to 9 months. Count of participants. Unit: Participants

Measure	Group A (Standard HPV Information) n = 412	Group B (Outsmart HPV, Unidirectional Vaccine Reminders) n = 407	Group C (Outsmart HPV, Interactive Vaccine Reminders) n = 408
HPV Vaccine Series Initiation: Yes	114	139	147
HPV Vaccine Series Initiation: No	298	268	261
HPV Vaccine Series Completion: Yes	14	30	47
HPV Vaccine Series Completion: No	398	377	361

Primary outcome: Changes in Theoretical Constructs

Time frame: Baseline up to 9 months. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Group A (Standard HPV Information) n = 295	Group B (Outsmart HPV, Unidirectional Vaccine Reminders) n = 271	Group C (Outsmart HPV, Interactive Vaccine Reminders) n = 276
Perceived severity of HPV-related disease	-0.04 (0.74)	0.01 (0.79)	-0.09 (0.75)
Response efficacy of HPV vaccine	0.41 (0.84)	0.58 (0.88)	0.50 (0.85)
Worry about getting HPV-related disease	0.63 (0.98)	0.56 (1.05)	0.57 (0.98)

Population analysed: Participants who completed the end-of-study survey at 9 months

Primary outcome: Counts of Human Papillomavirus (HPV) Vaccine Initiation by Participant Characteristics

Time frame: Baseline up to 9 months. Count of participants. Unit: Participants

Measure	Group A (Standard HPV Information) n = 412	Group B (Outsmart HPV, Unidirectional Vaccine Reminders) n = 407	Group C (Outsmart HPV, Interactive Vaccine Reminders) n = 408
Ages 18-21	41	53	46
Ages 22-25	73	86	101
High school education or less	33	44	39
Some college education or more	81	95	108
Preventive health visit within the last year	56	65	66
No preventive health visit within the last year	58	74	81

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A (Standard HPV Information)	0 of 412 (0%)	0 of 412 (0%)	0 of 412
Group B (Outsmart HPV, Unidirectional Vaccine Reminders)	0 of 407 (0%)	0 of 407 (0%)	0 of 407
Group C (Outsmart HPV, Interactive Vaccine Reminders)	0 of 408 (0%)	0 of 408 (0%)	0 of 408

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39752644Marshall 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.
Derived from this study: PubMed 32130192Reiter 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.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Reiter, PhD principal investigator

Ohio State University Comprehensive Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Human Papillomavirus (HPV) Vaccine Initiation and Completion (time frame: Baseline up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032106, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.