Healthy SubjectNCT02835755
Mobile Health Intervention in Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
A study testing Educational Intervention and Survey Administration in people with Healthy Subject, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine. Read more about this study
- 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?
- Educational Intervention and Survey Administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2016to 16 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Self-identifies as gay or bisexual
- Lives in the United States (US)
- Has not received any doses of HPV vaccine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine.
Read the detailed description
PRIMARY OBJECTIVES:
- Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual men to establish feasibility and acceptability.
II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.
SECONDARY OBJECTIVES:
- Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as the vaccine information statement (VIS), on a mobile-friendly website study portal.
GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail.
All patients complete a survey on the study portal at baseline, immediately after the mHealth intervention or control materials, and at 3 months and 7 months thereafter for about 10-15 minutes each.
- Conditions
- Healthy Subject
- Being tested
- Educational Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive standard HPV and HPV vaccine information
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive mHealth HPV vaccine intervention
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control) | Active comparator | Patients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. Receives: Other: Educational Intervention; Other: Survey Administration |
| Group II (mHealth HPV vaccine) | Experimental | Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail. Receives: Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability will be established by examining participant satisfaction with study materials
Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.
Measured: Up to 7 months
Feasibility established by achieving recruitment, retention, and medical record release goals
Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05
Measured: Up to 7 months
Receipt of 1 or more doses of HPV vaccine
Evaluated using logistic regression.
Measured: Up to 7 months
Secondary outcomes (2)
Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)
Evaluated using analysis of covariance models.
Measured: Up to 7 months
Receipt of second and third doses of HPV vaccine
Evaluated using logistic regression.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start11 Jul 2016
- Primary completion8 Sep 2016
- Study completion16 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul Reiter, Ohio State University Comprehensive Cancer Center
- Investigators
- Paul Reiter, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835755
- Sponsor's protocol ID
- OSU-15234
- Other IDs
- NCI-2016-00819, P30CA016058, R21CA194831
- Status last verified
- Aug 2017
- First submitted
- 13 Jul 2016
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reiter PL, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. Increasing Human Papillomavirus Vaccination Among Young Gay and Bisexual Men: A Randomized Pilot Trial of the Outsmart HPV Intervention. LGBT Health. 2018 Jul;5(5):325-329. doi: 10.1089/lgbt.2018.0059.
PubMed 29979642McRee AL, Shoben A, Bauermeister JA, Katz ML, Paskett ED, Reiter PL. Outsmart HPV: Acceptability and short-term effects of a web-based HPV vaccination intervention for young adult gay and bisexual men. Vaccine. 2018 Dec 18;36(52):8158-8164. doi: 10.1016/j.vaccine.2018.01.009. Epub 2018 Jan 10.
PubMed 29331245
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing HPV Vaccine Coverage Among Young Adult Gay and Bisexual Men
- ClinicalTrials.gov ID
- NCT02835755
- Acronym / sponsor ID
- OSU-15234
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 16 Apr 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV) vaccine intervention works in increasing HPV vaccine coverage among young adult gay and bisexual men. Giving young men information about the HPV vaccine and the importance of vaccination may encourage them to get the HPV vaccine.
Detailed description
PRIMARY OBJECTIVES:
- Pilot test a mobile health (mHealth) HPV vaccine intervention for young gay and bisexual men to establish feasibility and acceptability.
II. Obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.
SECONDARY OBJECTIVES:
- Examine whether the mHealth HPV vaccine intervention affects secondary outcomes compared to the control group.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients receive standard information about HPV and HPV vaccine, such as the vaccine information statement (VIS), on a mobile-friendly website study portal.
GROUP II (INTERVENTION): Patients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail.
All patients complete a survey on the study portal at baseline, immediately after the mHealth intervention or control materials, and at 3 months and 7 months thereafter for about 10-15 minutes each.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Control) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationPatients receive standard information about HPV and HPV vaccine, such as the VIS, on a mobile-friendly website study portal. |
| Group II (mHealth HPV vaccine) | Experimental | Other: Educational Intervention, Other: Survey AdministrationPatients receive the mHealth HPV vaccine intervention consisting of content about HPV and HPV vaccine on the study portal for 15 minutes and vaccination reminders sent by the portal via text or e-mail. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-identifies as gay or bisexual
- 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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive standard HPV and HPV vaccine information | Other | Group I (Control) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive mHealth HPV vaccine intervention | Other | Group II (mHealth HPV vaccine) |
| Survey AdministrationAncillary studies | Other | Group I (Control), Group II (mHealth HPV vaccine) |
Primary outcome
Acceptability will be established by examining participant satisfaction with study materials
Time frame: Up to 7 months
Linear regression will be used and usage data and satisfaction with vaccination reminders (intervention group only) will be descriptively examined.
Feasibility established by achieving recruitment, retention, and medical record release goals
Time frame: Up to 7 months
Critical parameters with point estimates and 95% confidence intervals will be estimated and tested with a two-sided alpha=.05
Receipt of 1 or more doses of HPV vaccine
Time frame: Up to 7 months
Evaluated using logistic regression.
2 secondary outcomes
Changes in potential mediators between study group and HPV vaccination (i.e., protection motivation theory [PMT] constructs and HPV and HPV vaccine knowledge)
Time frame: Up to 7 months
Receipt of second and third doses of HPV vaccine
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 29979642Reiter PL, Katz ML, Bauermeister JA, Shoben AB, Paskett ED, McRee AL. Increasing Human Papillomavirus Vaccination Among Young Gay and Bisexual Men: A Randomized Pilot Trial of the Outsmart HPV Intervention. LGBT Health. 2018 Jul;5(5):325-329. doi: 10.1089/lgbt.2018.0059.
- Derived from this study: PubMed 29331245McRee AL, Shoben A, Bauermeister JA, Katz ML, Paskett ED, Reiter PL. Outsmart HPV: Acceptability and short-term effects of a web-based HPV vaccination intervention for young adult gay and bisexual men. Vaccine. 2018 Dec 18;36(52):8158-8164. doi: 10.1016/j.vaccine.2018.01.009. Epub 2018 Jan 10.
- The JameslineLink provided by the sponsor.
Related trials for Healthy Subject
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Survey Administration in people with Healthy Subject, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 3 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 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability will be established by examining participant satisfaction with study materials (time frame: Up to 7 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 NCT02835755, 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 3 Aug 2017.