A Pilot Study Comparing the Effectiveness of Campus Intervention to Increase HPV Vaccine Rate Among College Aged Men

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ClinicalTrials.gov Identifier: NCT02508701

Recruitment Status : Terminated

First Posted : July 27, 2015

Results First Posted : September 20, 2018

Last Update Posted : September 20, 2018

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Stewart Chang Alexander, Purdue University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Human Papilloma Virus, Male	Behavioral: Message X Onsite/Offsite Vaccination	Not Applicable

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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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Non-Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Study Start Date :	August 2015
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Altruistic inside-dorm 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	Behavioral: Message X Onsite/Offsite Vaccination Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
Generic inside-dorm 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	Behavioral: Message X Onsite/Offsite Vaccination Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
Generic outside-dorm 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	Behavioral: Message X Onsite/Offsite Vaccination Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
Altruistic outside-dorm 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	Behavioral: Message X Onsite/Offsite Vaccination Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Number of Participants With Second Uptake Shot [ Time Frame: 6 months ]
Number of Participants With 3rd Uptake Shots [ Time Frame: 6 months ]
The Number of Participants with 3rd Uptake Shots

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 21 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must be young men between 18 to 21 years old
live in one of the dorm floors in the study

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508701

Sponsors and Collaborators

Purdue University

Merck Sharp & Dohme Corp.

Investigators

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Principal Investigator:	Stewart C Chang Alexander, PhD	Purdue University

More Information

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Responsible Party:	Stewart Chang Alexander, Associate Professor, Purdue University
ClinicalTrials.gov Identifier:	NCT02508701
Other Study ID Numbers:	1506016224
First Posted:	July 27, 2015 Key Record Dates
Results First Posted:	September 20, 2018
Last Update Posted:	September 20, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Stewart Chang Alexander, Purdue University:


HPV Message Design Adolescent Males

Additional relevant MeSH terms:

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Papilloma Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type	Neoplasms Vaccines Immunologic Factors Physiological Effects of Drugs

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