Human Papilloma Virus, MaleNCT02508701
A Pilot Study Comparing the Effectiveness of Campus Intervention to Increase HPV Vaccine Rate Among College Aged Men
A study testing Message X Onsite/Offsite Vaccination in people with Human Papilloma Virus, Male, run by Purdue University.
Trial summary
This is a study testing what type of message and access influences a young male to get the HPV vaccine. The investigators are conducting a 2 X 2 design These conditions are: Condition 1: Altruistic personal with direct recommendation inside-dorm Condition 2: Generic message with inside-dorm Condition 3: Generic… Read more about this study
- Who is it for?
- Ages 18 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Male
- What is being tested?
- Message X Onsite/Offsite Vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2016
- 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 21 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be young men between 18 to 21 years old
- live in one of the dorm floors in the study
Who cannot join
- Under 17 years old
- over 21 years old
- females
- young men that live outside the pre-identified dorm halls
- Also any young man with a moderate to severe illness will be excluded.
- anyone with a life threatening allergic reaction to components to the HPV vaccine
About this study
Official title: A Pilot Study Comparing the Effectiveness of On-site Campus Interventions to Increase the Uptake of the HPV Three-shot Series Vaccine Among College Aged Men: A 2 X 2 Repeated Design
This is a study testing what type of message and access influences a young male to get the HPV vaccine.
The investigators are conducting a 2 X 2 design
Read more
These conditions are:
- Condition 1: Altruistic personal with direct recommendation inside-dorm
- Condition 2: Generic message with inside-dorm
- Condition 3: Generic message with outside-dorm HPV vaccine
- Condition 4: Altruistic personal with outside-dorm HPV vaccine
The objectives of this study are:
- To examine the efficacy in encouraging young men to receive HPV shots at Time 1 within each of the four intervention conditions (altruistic/personal with direct recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).
- To examine the efficacy in encouraging young men to receive HPV shots at Times 2 \& 3 within each of the four intervention conditions (altruistic/personal with direct recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).
2.1.1 List the clinical hypotheses. Objective A H A.1: At Time 1, college men who have immediate access to the HPV vaccination will take the vaccination at a higher rate than those who do not have immediate access to the vaccine.
H A.2: At Time 1, college men who receive an altruistic/personal health message along with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the men in the other three arms of the study.
Objective B H B.1: At Times 2 \& 3, college men who have immediate access to the HPV vaccination will take the vaccination at a higher rate than those who do not have immediate access to the vaccine.
H B.2: At Times 2 \& 3, college men who receive an altruistic/personal health message along with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the men in the other three arms of the study.
Read the detailed description
The investigators will conduct an intervention on the Purdue campus targeting men-only dorm wings (living areas). Eight (8) dorm wings will be selected in advance.
Dorm wings will be randomly assigned to one of four intervention arms: (1) educational message with altruistic/personal health benefits emphasized along with a direct recommendation to get the vaccine along with immediate access to the vaccine with the dormitory (altruistic/personal benefit message with recommendation + in-dorm vaccine), (2) educational message with altruistic/personal health benefits emphasized along with information on where to go to get the vaccine (altruistic/personal benefit message with recommendation + outside-dorm vaccine) and (3) generic informational message about the HPV vaccine and immediate access to the vaccine in the dormitory (generic + on-site vaccine), (4) generic informational message with information on where to go to get the vaccine (generic + outside-dorm vaccine).
Phase 1 (Initial vaccine dose #1):
Recruitment of all four intervention arms will be occur at the same time during the dorm wing's first mandatory meetings for residents. These mandatory meetings occur throughout the campus. Fifty-two (52) residents live on each dorm wing and the first mandatory dorm meeting attendance is typically between 75-90% of all residents within the wing (between 47 and 52 men).
At the end of the mandatory wing meeting, a male research assistant will provide a brief presentation to the young men that describe the HPV vaccine (either altruistic/personal benefit message with recommendation or a generic message).
At the end of the brief presentation, residents will either be directed to the location where the HPV vaccine is set-up within the dormitory for immediate immunization (on-site vaccine) or provided a printed card that tells them how to get the vaccine on campus through the health center(outside-dorm vaccine). The location of the on-site vaccine will be close to the dorm wing.
Eligibility requirements will be determined at the site of the HPV vaccine by student health center staff members. These requirements are (over 18-years of age and have not received the three-shot series of the HPV vaccine).
For the on-site vaccine arms, once eligibility has been determined, research assistants will hand the young man over to the student health center staff (who will then conduct their typical vaccine protocol).
For those in the outside-dorm vaccine arms, students will go to the health center to receive the vaccine.
Phase 2 (2-month follow-up vaccine dose #2):
On-site vaccine arms. One week before the student health center staff will return to the dormitory for administer the second HPV dose, research assistants will contact participants by text and email to remind them of the follow-up. The investigators will also send a text message and email the night before. In addition, Resident Assistants will also be provided the name of the men in the study to remind participants of the returned visit the night before about the visit.
Outside-dorm vaccine. For those randomized to outside-dorm, research assistants will text and email participants one-week before their 2-month follow-up dose is needed. Resident Assistants will also be provided the name of the men in the study to remind participants about the getting the follow-up shot.
Phase 3: (6-month follow-up dose #3): The investigators will use the same protocol for the 6-month follow-up as the investigators use for the 2-month follow-up (reminder one week before and the night before using email, text, and resident assistants).
- Conditions
- Human Papilloma Virus, Male
- Being tested
- Message X Onsite/Offsite Vaccination
- Keywords
- HPV, Message Design, Adolescent Males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message X Onsite/Offsite VaccinationBehavioural
Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Altruistic inside-dorm | Other | Altruistic \& personal message with direct recommendation and access to the vaccine on-site
The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm and provides a direct recommendation to get the vaccine Receives: Behavioral: Message X Onsite/Offsite Vaccination |
| Generic inside-dorm | Other | Generic message and access to the vaccine on-site
The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm but provides no recommendation Receives: Behavioral: Message X Onsite/Offsite Vaccination |
| Generic outside-dorm | Other | Generic message and off-site access to the vaccine
The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the health center but provides no recommendation Receives: Behavioral: Message X Onsite/Offsite Vaccination |
| Altruistic outside-dorm | Other | Altruistic \& personal message with direct recommendation and off-site access to the vaccine
The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the student health center and provides a direct appeal to get the vaccine Receives: Behavioral: Message X Onsite/Offsite Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 1st Uptake Shots
Number of Participants with the 1st Uptake Shots
Measured: Up to 12 months
Number of Participants With 1st Uptake Shot
The Number of Participants with 1st Uptake Shot
Measured: 6 months
Secondary outcomes (2)
Number of Participants With Second Uptake Shot
Measured: 6 months
Number of Participants With 3rd Uptake Shots
The Number of Participants with 3rd Uptake Shots
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
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.
- Other trials for Human Papilloma Virus, MaleStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Stewart Chang Alexander, Purdue University
- Investigators
- Stewart C Chang Alexander, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508701
- Sponsor's protocol ID
- 1506016224
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2015
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing the Effectiveness of On-site Campus Interventions to Increase the Uptake of the HPV Three-shot Series Vaccine Among College Aged Men: A 2 X 2 Repeated Design
- ClinicalTrials.gov ID
- NCT02508701
- Acronym / sponsor ID
- 1506016224
- Conditions
- Human Papilloma Virus, Male
- Keywords
- HPV, Message Design, Adolescent Males
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study testing what type of message and access influences a young male to get the HPV vaccine.
The investigators are conducting a 2 X 2 design
These conditions are:
- Condition 1: Altruistic personal with direct recommendation inside-dorm
- Condition 2: Generic message with inside-dorm
- Condition 3: Generic message with outside-dorm HPV vaccine
- Condition 4: Altruistic personal with outside-dorm HPV vaccine
The objectives of this study are:
- To examine the efficacy in encouraging young men to receive HPV shots at Time 1 within each of the four intervention conditions (altruistic/personal with direct recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).
- To examine the efficacy in encouraging young men to receive HPV shots at Times 2 \& 3 within each of the four intervention conditions (altruistic/personal with direct recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).
2.1.1 List the clinical hypotheses. Objective A H A.1: At Time 1, college men who have immediate access to the HPV vaccination will take the vaccination at a higher rate than those who do not have immediate access to the vaccine.
H A.2: At Time 1, college men who receive an altruistic/personal health message along with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the men in the other three arms of the study.
Objective B H B.1: At Times 2 \& 3, college men who have immediate access to the HPV vaccination will take the vaccination at a higher rate than those who do not have immediate access to the vaccine.
H B.2: At Times 2 \& 3, college men who receive an altruistic/personal health message along with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the men in the other three arms of the study.
Detailed description
The investigators will conduct an intervention on the Purdue campus targeting men-only dorm wings (living areas). Eight (8) dorm wings will be selected in advance.
Dorm wings will be randomly assigned to one of four intervention arms: (1) educational message with altruistic/personal health benefits emphasized along with a direct recommendation to get the vaccine along with immediate access to the vaccine with the dormitory (altruistic/personal benefit message with recommendation + in-dorm vaccine), (2) educational message with altruistic/personal health benefits emphasized along with information on where to go to get the vaccine (altruistic/personal benefit message with recommendation + outside-dorm vaccine) and (3) generic informational message about the HPV vaccine and immediate access to the vaccine in the dormitory (generic + on-site vaccine), (4) generic informational message with information on where to go to get the vaccine (generic + outside-dorm vaccine).
Phase 1 (Initial vaccine dose #1):
Recruitment of all four intervention arms will be occur at the same time during the dorm wing's first mandatory meetings for residents. These mandatory meetings occur throughout the campus. Fifty-two (52) residents live on each dorm wing and the first mandatory dorm meeting attendance is typically between 75-90% of all residents within the wing (between 47 and 52 men).
At the end of the mandatory wing meeting, a male research assistant will provide a brief presentation to the young men that describe the HPV vaccine (either altruistic/personal benefit message with recommendation or a generic message).
At the end of the brief presentation, residents will either be directed to the location where the HPV vaccine is set-up within the dormitory for immediate immunization (on-site vaccine) or provided a printed card that tells them how to get the vaccine on campus through the health center(outside-dorm vaccine). The location of the on-site vaccine will be close to the dorm wing.
Eligibility requirements will be determined at the site of the HPV vaccine by student health center staff members. These requirements are (over 18-years of age and have not received the three-shot series of the HPV vaccine).
For the on-site vaccine arms, once eligibility has been determined, research assistants will hand the young man over to the student health center staff (who will then conduct their typical vaccine protocol).
For those in the outside-dorm vaccine arms, students will go to the health center to receive the vaccine.
Phase 2 (2-month follow-up vaccine dose #2):
On-site vaccine arms. One week before the student health center staff will return to the dormitory for administer the second HPV dose, research assistants will contact participants by text and email to remind them of the follow-up. The investigators will also send a text message and email the night before. In addition, Resident Assistants will also be provided the name of the men in the study to remind participants of the returned visit the night before about the visit.
Outside-dorm vaccine. For those randomized to outside-dorm, research assistants will text and email participants one-week before their 2-month follow-up dose is needed. Resident Assistants will also be provided the name of the men in the study to remind participants about the getting the follow-up shot.
Phase 3: (6-month follow-up dose #3): The investigators will use the same protocol for the 6-month follow-up as the investigators use for the 2-month follow-up (reminder one week before and the night before using email, text, and resident assistants).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Altruistic inside-dorm | Other | Behavioral: Message X Onsite/Offsite VaccinationAltruistic \& personal message with direct recommendation and access to the vaccine on-site The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm and provides a direct recommendation to get the vaccine |
| Generic inside-dorm | Other | Behavioral: Message X Onsite/Offsite VaccinationGeneric message and access to the vaccine on-site The intervention is a message asking students to get the vaccine that tell students the vaccine is available in the dorm but provides no recommendation |
| Generic outside-dorm | Other | Behavioral: Message X Onsite/Offsite VaccinationGeneric message and off-site access to the vaccine The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the health center but provides no recommendation |
| Altruistic outside-dorm | Other | Behavioral: Message X Onsite/Offsite VaccinationAltruistic \& personal message with direct recommendation and off-site access to the vaccine The intervention is a message asking students to get the vaccine that tell students the vaccine is available at the student health center and provides a direct appeal to get the vaccine |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be young men between 18 to 21 years old
- live in one of the dorm floors in the study
Key exclusion criteria (6 listed)
- Under 17 years old
- over 21 years old
- females
- young men that live outside the pre-identified dorm halls
- Also any young man with a moderate to severe illness will be excluded.
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 |
|---|---|---|
| Message X Onsite/Offsite VaccinationPersonal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination | Behavioural | Altruistic inside-dorm, Altruistic outside-dorm, Generic inside-dorm, Generic outside-dorm |
Primary outcome
Number of Participants With 1st Uptake Shots
Time frame: Up to 12 months
Number of Participants with the 1st Uptake Shots
Number of Participants With 1st Uptake Shot
Time frame: 6 months
The Number of Participants with 1st Uptake Shot
2 secondary outcomes
Number of Participants With Second Uptake Shot
Time frame: 6 months
Number of Participants With 3rd Uptake Shots
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stewart C Chang Alexander, PhD principal investigator
Purdue University
Questions about this trial
What is this clinical trial studying?
A study testing Message X Onsite/Offsite Vaccination in people with Human Papilloma Virus, Male, run by Purdue University.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 20 Sep 2018). 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?
Number of Participants With 1st Uptake Shots (time frame: Up to 12 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 20 Sep 2018.