Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
AIDS Action Baltimore, Baltimore, MD, USA.
HIV Res Clin Pract. 2021 Feb;22(1):14-30. doi: 10.1080/25787489.2021.1902116. Epub 2021 Mar 24.
Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV.
Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs.
We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations.
Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants.
While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.
在 HIV 治愈相关研究中，分析性治疗中断（ATI）可能导致试验参与者的 HIV 病毒血症，使 HIV 阴性的性伴侣面临更高的 HIV 感染风险。
我们的研究旨在为设计和实施适当的风险缓解策略提供伦理和实践方面的考虑，以减少 ATI 期间意外的 HIV 传播事件。
我们对五类信息提供者进行了 21 次深入访谈：生物伦理学家、社区成员、生物医学 HIV 治愈研究人员、社会行为科学家/流行病学家和 HIV 护理提供者。我们使用常规内容分析来分析数据并生成考虑因素。
主要发现包括：1）ATI 试验的伦理可接受性取决于尽职调查和知情同意，以减轻参与者及其性伴侣的风险；2）如果参与者选择向其伴侣透露 ATI 参与情况，他们应获得足够的支持和/或咨询；3）在 ATI 期间保护试验参与者的性伴侣免受 HIV 传播的措施应包括转介和/或提供暴露前预防，以及其他预防 HIV 传播的可用手段；4）在 ATI 试验期间出现新的性传播感染的适当管理以及对 ATI 试验参与者的多个和/或匿名性伴侣的可能保护措施存在不确定性。
虽然无法完全消除 ATI 期间 HIV 传播给性伴侣的风险，但 HIV 治愈研究人员和赞助商应考虑与 ATI 参与者的性伴侣相关的伦理问题。这样做对于确保参与者、其伴侣和研究的可信度的福利至关重要。
