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未成年人和青年在 HIV 暴露前预防的 II 期安全性研究中的研究同意过程体验。

Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV.

机构信息

Department of Community & Health Systems, Indiana University School of Nursing, Indianapolis, Indiana.

Department of Pediatrics, Adolescent Medicine, Indiana University School of Medicine, Indianapolis, Indiana.

出版信息

J Adolesc Health. 2017 Dec;61(6):747-754. doi: 10.1016/j.jadohealth.2017.06.013. Epub 2017 Sep 28.


DOI:10.1016/j.jadohealth.2017.06.013
PMID:28967541
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5701834/
Abstract

PURPOSE: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. METHODS: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled. RESULTS: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. CONCLUSIONS: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.

摘要

目的:在美国,性少数群体和跨性别青少年中存在持续的 HIV 流行。口服暴露前预防(PrEP)是一种有效的预防策略,但尚未批准用于未成年人。未成年人获得生物医学 HIV 预防技术受到同意参与研究的伦理和法律复杂性的阻碍。我们探讨了自主同意,并研究了 Project PrEPare 中的未成年和成年参与者的经验,这是一项针对 HIV 预防的 PrEP 安全性研究的第二阶段。

方法:本混合方法描述性研究的数据通过 2016 年初的自我管理网络调查和深入的电话访谈收集。符合条件的参与者以前曾参加过 Project PrEPare。我们试图联系 191 名参与者;有 74 名参与者联系并表示有兴趣参与,其中 58 名参与者参与。

结果:参与者普遍感到消息灵通、了解研究情况,并在明确了解可以随时退出的情况下自愿参与。所有人都感到研究人员的支持,但少数人希望在登记期间得到更多支持。未成年人比成年人更有可能表示希望在决策过程中得到更多支持,而成年人对自己的决定表示出比未成年人更高的满意度。同意的各个要素与 Project PrEPare 研究结果之间没有关联。

结论:参与者在一项针对 HIV 预防的 PrEP 安全性研究中获得了压倒性的积极体验。一些未成年人希望在决策过程中得到更多支持,但没有人就该决定咨询他们的父母。我们的研究结果支持在青少年同意过程中纳入决策支持,同时保护他们的隐私。

相似文献

[1]
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[2]
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[3]
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[4]
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[5]
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[6]
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J Adolesc Health. 2023-5

[7]
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[8]
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[9]
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[10]
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本文引用的文献

[1]
An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.

J Acquir Immune Defic Syndr. 2017-1-1

[2]
"I Won't Out Myself Just to Do a Survey": Sexual and Gender Minority Adolescents' Perspectives on the Risks and Benefits of Sex Research.

Arch Sex Behav. 2017-7

[3]
Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

Res Ethics. 2016-4

[4]
Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.

J Empir Res Hum Res Ethics. 2016-2

[5]
Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

J Adolesc Health. 2015-7

[6]
Enrollment of adolescents aged 16-17 years old in microbicide trials: an evidence-based approach.

J Adolesc Health. 2014-3-29

[7]
Preventive misconception and adolescents' knowledge about HIV vaccine trials.

J Med Ethics. 2013-12

[8]
State adolescent consent laws and implications for HIV pre-exposure prophylaxis.

Am J Prev Med. 2013-1

[9]
Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision.

J Med Ethics. 2012-8-8

[10]
Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research.

J Acquir Immune Defic Syndr. 2010-7

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