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

2018년 8월 31일 업데이트: Stewart Chang Alexander, Purdue University

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.

연구 개요

상세 설명

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).

연구 유형

중재적

등록 (실제)

24

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

남성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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

Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
다른: 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

Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
다른: 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

Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
다른: 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

Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With 1st Uptake Shots
기간: Up to 12 months
Number of Participants with the 1st Uptake Shots
Up to 12 months
Number of Participants With 1st Uptake Shot
기간: 6 months
The Number of Participants with 1st Uptake Shot
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Second Uptake Shot
기간: 6 months
6 months
Number of Participants With 3rd Uptake Shots
기간: 6 months
The Number of Participants with 3rd Uptake Shots
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Stewart C Chang Alexander, PhD, Purdue University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 8월 1일

기본 완료 (실제)

2016년 5월 1일

연구 완료 (실제)

2016년 5월 1일

연구 등록 날짜

최초 제출

2015년 7월 24일

QC 기준을 충족하는 최초 제출

2015년 7월 24일

처음 게시됨 (추정)

2015년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 31일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

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아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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