- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01087164
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents
연구 개요
상세 설명
The proposed study will employ a randomized, full factorial experimental design to examine the effects of brief message interventions on parents' acceptance of the first dose of HPV vaccine for their adolescents aged 11-14 years, as well as follow through with subsequent doses. Specifically, the study will employ a 2 x 2 experimental design, in which participants will be assigned randomly to one of two different message sidedness conditions (1 sided vs. 2 sided) and two social compliance conditions (high compliance request [HCR] vs. noHCR). The interventions will be administered by a bilingual research assistant who will read, verbatim, scripts provided to them. Computer assisted telephone interview (CATI) will be used to gather demographic and background information as well as parental health beliefs regarding preexisting worries about HPV vaccine leading to safety concerns (moderator variable) prior to administration of the interventions. After the interventions, additional health beliefs will be assessed (mediators).
- A greater proportion of girls as compared to boys will receive a first dose of vaccine.
- Among both girls and boys who receive a first dose of Gardasil™, no differences in completion rates will be detected.
- The social compliance intervention to be more effective with parents of girls as compared to parents of boys. This prediction of a differential effect is based on the fact that cervical cancer will be seen as a more serious and less stigmatizing condition than genital warts.
In summary, the implementation of this protocol will allow us to systematically examine the use of two different interventions on parents of both boys and girls. Thus, parents (n=800) of 11-14 year old girls and boys will be randomized to the two sets of interventions, resulting in a 2 X 2 design: message sidedness (1-sided; 2-sided) and HCR (yes; no).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Galveston, Texas, 미국, 77550
- Teen Health Centers
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The parents of adolescent males and females (aged 11-14 years) who have provided written consent for their adolescent to receive health care services through the Teen Health Center, Inc, a nonprofit organization that works in collaboration with the Department of Pediatrics at the University of Texas Medical Branch, Galveston, Texas and whose adolescents have not received their first dose of HPV vaccine, will be eligible to participate.
Exclusion Criteria:
- Having received one or more doses of the HPV vaccine Gardasil
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Compliance
Parents will be randomized to receive high or no compliance condition where those in the experimental group will be asked about whether or not they will protect their daughter from cervical cancer or for males, their son from genital warts.
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Parent will either receive a high or no compliance condition where each is asked to endorse the importance of prevention cervical cancer or genital warts depending on their teen's gender.
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실험적: Message sidedness
Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.
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Parent will receive either a one-sided or two-sided message about the HPV vaccine
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Gardasil immunization
기간: One year
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Parent signs vaccine information sheet and returns to school-based health center.
Adolescent is vaccinated with first dose of Gardasil by licensed health care professional.
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One year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Completion of three dose series of Gardasil
기간: Three years
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We will identify all enrolled parents to determine whether their adolescent received all three required Gardasil immunization across a three year period.
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Three years
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Message type
기간: Two years
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Determine whether the type of message delivered to parent, i.e., one-sided or two-sided, increases the number of first dose immunizations.
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Two years
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Gender
기간: One year
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Determine if there are gender differences between male and female children relative to first dose administration
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One year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vaughn I Rickert, PsyD, Indiana University school of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0911-50
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Compliance에 대한 임상 시험
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Wolfson Medical Center알려지지 않은