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临床试验/NCT02508701
NCT02508701终止不适用

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

Purdue University0 个研究点目标入组 24 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
24
主要终点
Number of Participants With 1st Uptake Shots

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 21 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

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

排除标准

  • •Under 17 years old
  • •over 21 years old
  • •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

研究组 & 干预措施

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

干预措施: Message X Onsite/Offsite Vaccination (Behavioral)

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

干预措施: Message X Onsite/Offsite Vaccination (Behavioral)

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

干预措施: Message X Onsite/Offsite Vaccination (Behavioral)

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

干预措施: Message X Onsite/Offsite Vaccination (Behavioral)

结局指标

主要结局

Number of Participants With 1st Uptake Shots

时间窗: Up to 12 months

Number of Participants with the 1st Uptake Shots

Number of Participants With 1st Uptake Shot

时间窗: 6 months

The Number of Participants with 1st Uptake Shot

次要结局

  • Number of Participants With Second Uptake Shot(6 months)
  • Number of Participants With 3rd Uptake Shots(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stewart Chang Alexander

Associate Professor

Purdue University

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