Human Papilloma Virus, Male Clinical Trial
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
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:
A. 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).
B. 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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02897232 -
Community and Physician Perspectives Regarding Male Youth Human Papillomavirus (HPV) Disease and Vaccination
|