- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06700447
남아프리카의 청소년 소녀와 젊은 여성을 대상으로 한 HIV 백신 잘못된 정보로부터 보호하기 (PROTECT)
2026년 8월 7일 업데이트: University of Pennsylvania
예방 및 치료 프로그램의 기록적인 진전에도 불구하고 남아프리카공화국에서는 15~24세 사이의 청소년기 소녀와 젊은 여성(AGYW)이 인간 면역결핍 바이러스(HIV) 감염을 계속해서 겪고 있습니다.
HIV 감염에 대한 젊은 여성의 지속적인 민감성과 매우 효과적인 노출 전 예방(PrEP)과 같은 예방 옵션의 차선책 활용으로 인해 HIV 감염 위험이 상당한 인구 집단에 혜택을 줄 수 있는 HIV 백신이 필요합니다.
그러나 이전 백신 연구와 최근 코로나19 백신의 교훈은 널리 퍼진 잘못된 정보와 백신 주저와 같은 백신 활용에 대한 심각한 장벽을 강조했습니다.
이러한 과제는 미래의 HIV 백신의 성공적인 구현을 위협합니다.
이러한 통찰력을 바탕으로 이 연구는 심리 접종 이론을 활용하여 청소년기 소녀와 젊은 여성을 대상으로 HIV 백신 메시지를 개발하고 평가할 것입니다.
1차 목표: 심리적 접종 및 행동 경제학 강화가 있는 그룹과 없는 그룹의 잘못된 정보 노출에 따른 HIV 백신 접종 의도의 변화를 비교합니다.
이차 목표: (1) 심리적 예방접종 및 행동경제학 강화가 있거나 없는 그룹의 잘못된 정보와 관련된 잘못된 정보 주장 및 동기 부여 위협의 신뢰성과 설득력을 비교합니다.
(2) HIV 위험, PrEP 이력, 코로나19 백신 이력, 일반적인 백신 주저, 정보 회피 등 관련 사회인구통계학적 및 행동 요인에 따른 하위그룹 효과를 탐색합니다.
조사관은 남아프리카의 HIV 백신에 대한 새로운 통념과 잘못된 정보를 다루는 2~3가지 접종 메시지에 대한 3군 무작위 대조 시험을 실시할 것입니다.
참가자는 무작위로 통제 그룹이나 두 개의 개입 부문 중 하나에 배정됩니다: (1) 예방접종 메시지 부문 또는 (2) 행동경제학의 통찰력으로 예방접종 메시지 강화.
연구 개요
연구 유형
중재적
등록 (실제)
2163
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Johannesburg, 남아프리카
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
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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
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 여성
- 18~24세
- 지난 12개월간 성행위에 대해 스스로 보고한 이력
- 등록 시 자가 보고된 HIV 음성 상태 또는 알 수 없는 HIV 상태
- 서면 동의를 제공할 의지와 능력이 있음
- 영어를 읽고 이해할 수 있는 분
제외 기준:
- 연구 참여에 대한 동의를 제공할 의사가 없거나 제공할 수 없습니다.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 제어
대조군에 등록한 참가자는 접종 메시지와 동일한 길이의 당뇨병 및 영양 주제에 대한 관련없는 정보를받습니다.
이 메시지가 어떻게 구성되는지에 대한 예는 부록 6을 참조하십시오.
이를 통해 통제 그룹을주의 통제 그룹으로 만들고 중재 그룹이 연구에 참여할 때 더 많은 시간과주의 자원을 소비하여 결과가 혼란스럽지 않도록합니다.
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대조군에 등록한 참가자는 접종 메시지와 동일한 길이의 당뇨병 및 영양 주제에 대한 관련없는 정보를받습니다.
이 메시지가 어떻게 구성되는지에 대한 예는 부록 6을 참조하십시오.
이를 통해 통제 그룹을주의 통제 그룹으로 만들고 중재 그룹이 연구에 참여할 때 더 많은 시간과주의 자원을 소비하여 결과가 혼란스럽지 않도록합니다.
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다른: 개선 된 접종 메시지
강화 된 접종 메시지 ARM에 등록한 참가자는 임박한 HIV 백신 잘못된 정보에 대한 경고를받는 메시지를 받고 해당 청구가 거짓 또는 오해의 소지가있는 이유를 설명하면 행동 경제학의 통찰력으로 메시지가 응용서 5 : "접종 메시지를 가진 접종 메시지"를 참조하십시오.
행동 경제학 부스트의 일환으로 참가자는 예방 접종을 일관성 및 약정 프라이트로 홍보하는 메시지가 포함 된 작은 토큰 (예 : 스티커, 배지, 팔찌)을받을 수 있습니다.
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강화 된 접종 메시지 ARM에 등록한 참가자는 임박한 HIV 백신 잘못된 정보에 대한 경고를받는 메시지를 받고 해당 청구가 거짓 또는 오해의 소지가있는 이유를 설명하면 행동 경제학의 통찰력으로 메시지가 응용서 5 : "접종 메시지를 가진 접종 메시지"를 참조하십시오.
행동 경제학 부스트의 일환으로 참가자는 예방 접종을 일관성 및 약정 프라이트로 홍보하는 메시지가 포함 된 작은 토큰 (예 : 스티커, 배지, 팔찌)을받을 수 있습니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HIV Vaccine Intention, at the End of the Baseline Assessment
기간: At the end of the baseline assessment
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Intention to get the HIV vaccine, measured after inoculation intervention and misinformation exposure The intention to get the vaccine will be measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
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At the end of the baseline assessment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HIV Vaccine Intention, Follow-up
기간: 2-4 weeks
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Intention to get the HIV vaccine, measured at follow-up survey following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
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2-4 weeks
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Recommend to Friends, at the End of the Baseline Assessment
기간: At the end of the baseline assessment
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Intention to recommend the HIV vaccine to friends, measured at survey baseline following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
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At the end of the baseline assessment
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Recommend to Friends, Follow-up
기간: 2-4 weeks
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Intention to recommend the HIV vaccine to friends, measured at follow-up survey following misinformation exposure and intervention, controlling for baseline pre-intervention/exposure intention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
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2-4 weeks
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Credibility of Inoculated Exposure #1
기간: At the end of the baseline assessment
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Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #2
기간: At the end of the baseline assessment
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Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #3
기간: At the end of the baseline assessment
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Extent to which claim #3 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #4
기간: At the end of the baseline assessment
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Extent to which claim #4 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #5
기간: At the end of the baseline assessment
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Extent to which claim #5 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #6
기간: At the end of the baseline assessment
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Extent to which claim #6 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #1
기간: At the end of the baseline assessment
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Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #2
기간: At the end of the baseline assessment
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Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #3
기간: At the end of the baseline assessment
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Extent to which claim #3 made the participants anxious or nervous about the HIV vaccine.
TThey were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #4
기간: At the end of the baseline assessment
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Extent to which claim #4 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #5
기간: At the end of the baseline assessment
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Extent to which claim #5 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Anxiousness of Inoculated Exposure #6
기간: At the end of the baseline assessment
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Extent to which claim #6 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #1
기간: At the end of the baseline assessment
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Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #7
기간: At the end of the baseline assessment
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Extent to which claim #7 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #3
기간: At the end of the baseline assessment
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Extent to which claim #3 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #4
기간: At the end of the baseline assessment
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Extent to which claim #4 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #5
기간: At the end of the baseline assessment
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Extent to which claim #5 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Shareability of Inoculated Exposure #6
기간: At the end of the baseline assessment
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Extent to which claim #6 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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At the end of the baseline assessment
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Credibility of Inoculated Exposure #1, Follow-up
기간: 2-4 weeks
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Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Credibility of Inoculated Exposure #2, Follow-up
기간: 2-4 weeks
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Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Shareability of Inoculated Exposure #1, Follow-up
기간: 2-4 weeks
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Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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2-4 weeks
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Shareability of Inoculated Exposure #2, Follow-up
기간: 2-4 weeks
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Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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2-4 weeks
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Anxiousness of Inoculated Exposure #1, Follow-up
기간: 2-4 weeks
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Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Anxiousness of Inoculated Exposure #2, Follow-up
기간: 2-4 weeks
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Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Credibility of New Claims, Exposure #12, Follow-up
기간: 2-4 weeks
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Extent to which claim #12 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Credibility of New Claims, Exposure #8, Follow-up
기간: 2-4 weeks
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Extent to which claim #8 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Credibility of New Claims, Exposure #9, Follow-up
기간: 2-4 weeks
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Extent to which claim #9 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Credibility of New Claims, Exposure #10, Follow-up
기간: 2-4 weeks
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Extent to which claim #10 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Credibility of New Claims, Exposure #11, Follow-up
기간: 2-4 weeks
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Extent to which claim #11 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
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2-4 weeks
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Anxiousness o of New Claims, Exposure #12, Follow-up
기간: 2-4 weeks
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Extent to which claim #12 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Anxiousness of New Claims, Claim #8, Follow-up
기간: 2-4 weeks
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Extent to which claim #8 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Anxiousness of New Claims, Exposure #9, Follow-up
기간: 2-4 weeks
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Extent to which claim #9 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Anxiousness of New Claims, Exposure #10, Follow-up
기간: 2-4 weeks
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Extent to which claim #10 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Anxiousness of New Claims, Exposure #11, Follow-up
기간: 2-4 weeks
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Extent to which claim #11 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
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2-4 weeks
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Shareability of New Claims, Exposure #12, Follow-up
기간: 2-4 weeks
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Extent to which claim #12 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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2-4 weeks
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Shareability of New Claims, Exposure #8, Follow-up
기간: 2-4 weeks
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Extent to which claim #8 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
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2-4 weeks
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Shareability of New Claims, Exposure #9, Follow-up
기간: 2-4 weeks
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Extent to which claim #9 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #10, Follow-up
기간: 2-4 weeks
|
Extent to which claim #10 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #11, Follow-up
기간: 2-4 weeks
|
Extent to which claim #11 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Credibility of Inoculated Exposure #7
기간: At the end of the baseline assessment
|
Extent to which claim #7 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #7
기간: At the end of the baseline assessment
|
Extent to which claim #7 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #2
기간: At the end of the baseline assessment
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Credibility of New Claims, Exposure #13, Follow-up
기간: 2-4 weeks
|
Extent to which claim #13 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #13, Follow-up
기간: 2-4 weeks
|
Extent to which claim #13 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #13, Follow-up
기간: 2-4 weeks
|
Extent to which claim #13 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2025년 7월 24일
기본 완료 (실제)
2025년 10월 16일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2024년 11월 7일
QC 기준을 충족하는 최초 제출
2024년 11월 18일
처음 게시됨 (실제)
2024년 11월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 7일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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. .