Healthy SubjectNCT02960100
mHealth Intervention in Increasing HPV Vaccinations in College Students
A study testing Informational Intervention, Media 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 randomized pilot trial studies how well a mobile health (mHealth) intervention works in increasing human papillomavirus (HPV) vaccination among college students at the Ohio State University. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Informational Intervention, Media Intervention and Survey Administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to 31 Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled as a first year Ohio State University (OSU) student on the Columbus campus
- Being able to read English
- Not having received any doses of the 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: S.M.A.R.T. (Students Motivating and Acting in Real-Time) eStudy
This randomized pilot trial studies how well a mobile health (mHealth) intervention works in increasing human papillomavirus (HPV) vaccination among college students at the Ohio State University. mHealth educational intervention may communicate information about HPV vaccination and increase HPV vaccine uptake in college students.
Read the detailed description
PRIMARY OBJECTIVES:
- Pilot test an mHealth HPV vaccine intervention for college students 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: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message.
ARM II: Participants receive standard information about HPV and then HPV vaccine information statement (VIS) via the mobile-friendly website.
After completion of study, participants are followed up at 3 and 7 months.
- Conditions
- Healthy Subject
- Being tested
- Informational Intervention, Media Intervention, Survey Administration
- Keywords
- Cancer prevention, HPV, Human papillomavirus vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive standard HPV vaccine information (HPV VIS)
Media InterventionOther
Receive targeted HPV vaccine narrative-style video
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (mHealth HPV vaccine intervention) | Experimental | Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message. Receives: Other: Media Intervention; Other: Survey Administration |
| Arm II (standard HPV information and HPV VIS) | Active comparator | Participants receive standard information with the HPV Vaccine Information Statement via the mobile-friendly website. Receives: Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of the first dose of HPV vaccine in intervention and control group
Will obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.
Measured: Up to 7 months
Participant satisfaction scores
Acceptability and feasibility will be established by examining participant satisfaction with study materials.
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 posted9 Nov 2016 (estimated)
- Study start18 Oct 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mira Katz, Ohio State University Comprehensive Cancer Center
- Investigators
- Mira Katz, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960100
- Sponsor's protocol ID
- OSU-16109
- Other IDs
- NCI-2016-01449, P30CA016058
- Status last verified
- Feb 2018
- First submitted
- 7 Nov 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S.M.A.R.T. (Students Motivating and Acting in Real-Time) eStudy
- ClinicalTrials.gov ID
- NCT02960100
- Acronym / sponsor ID
- OSU-16109
- Conditions
- Healthy Subject
- Keywords
- Cancer prevention, HPV, Human papillomavirus vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 9 Nov 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 randomized pilot trial studies how well a mobile health (mHealth) intervention works in increasing human papillomavirus (HPV) vaccination among college students at the Ohio State University. mHealth educational intervention may communicate information about HPV vaccination and increase HPV vaccine uptake in college students.
Detailed description
PRIMARY OBJECTIVES:
- Pilot test an mHealth HPV vaccine intervention for college students 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: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message.
ARM II: Participants receive standard information about HPV and then HPV vaccine information statement (VIS) via the mobile-friendly website.
After completion of study, participants are followed up at 3 and 7 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (mHealth HPV vaccine intervention) | Experimental | Other: Media Intervention, Other: Survey AdministrationParticipants receive targeted HPV vaccine narrative-style video via the mobile-friendly website. Participants also receive monthly HPV vaccination reminders via email or by text message. |
| Arm II (standard HPV information and HPV VIS) | Active comparator | Other: Informational Intervention, Other: Survey AdministrationParticipants receive standard information with the HPV Vaccine Information Statement via the mobile-friendly website. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Currently enrolled as a first year Ohio State University (OSU) student on the Columbus campus
- Being able to read English
- Not having received any doses of the 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 |
|---|---|---|
| Informational InterventionReceive standard HPV vaccine information (HPV VIS) | Other | Arm II (standard HPV information and HPV VIS) |
| Media InterventionReceive targeted HPV vaccine narrative-style video | Other | Arm I (mHealth HPV vaccine intervention) |
| Survey AdministrationAncillary studies | Other | Arm I (mHealth HPV vaccine intervention), Arm II (standard HPV information and HPV VIS) |
Primary outcome
Receipt of the first dose of HPV vaccine in intervention and control group
Time frame: Up to 7 months
Will obtain preliminary efficacy data on whether the mHealth HPV vaccine intervention increases HPV vaccine initiation compared to the control group.
Participant satisfaction scores
Time frame: Up to 7 months
Acceptability and feasibility will be established by examining participant satisfaction with study materials.
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 22 Feb 2018.
- 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.
Mira Katz, 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 Informational Intervention, Media 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 22 Feb 2018. 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?
Receipt of the first dose of HPV vaccine in intervention and control group (time frame: Up to 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.