Sugarman Jeremy, Bollinger Juli, Agostini Jose, Weinfurt Kevin, Geller Gail, Jose Sheethal, Hannah Marissa, Edwards O Winslow, Henry Leslie Meltzer, Sanchez Travis
Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD, 21205, United States, 1 410-614-5634.
School of Medicine, Johns Hopkins University, Baltimore, MD, United States.
JMIR Public Health Surveill. 2025 Apr 11;11:e64663. doi: 10.2196/64663.
Molecular HIV surveillance (MHS) can be used to help identify and respond to emerging clusters of rapidly spreading HIV transmissions, a practice known as cluster detection and response (CDR). In the United States, MHS relies on HIV gene sequences obtained from routine clinical antiretroviral resistance testing (ARVRT). By law, ARVRT results are reported to public health agencies for MHS and individuals are not asked for their specific consent to do so. This practice has raised ethical concerns, including the lack of consent for, and transparency surrounding, public health uses of these clinical data. Such concerns have spurred debate and could have a chilling effect on the willingness of people living with HIV to agree to ARVRT when recommended clinically and jeopardize the utility of MHS-informed HIV prevention efforts. In response to the lack of routine disclosure of use of ARVRT results for MHS, in 2022, the Presidential Advisory Council on HIV/AIDS (PACHA) issued a resolution calling on the US Centers for Disease Control to "require that providers explain MHS/CDR and the laboratory test results that are collected and used in these surveillance activities to their patients."
This study aimed to examine the effect of clinician disclosure of the public health uses of ARVRT results for MHS versus clinician nondisclosure on patient willingness to undergo recommended ARVRT.
We conducted a randomized survey experiment examining the effect of clinician disclosure of the public health uses of ARVRT results for MHS versus clinician nondisclosure (the current standard of care) and subsequent discovery of such uses through a "trusted media source" on patient willingness to undergo recommended ARVRT. Study participants were respondents to 1 of 2 national web-based surveys conducted annually in the United States: the American Men's Internet Survey (AMIS) and the Transgender Women's Internet Survey and Testing (TWIST).
Overall, 4348 AMIS participants (n=2151 disclosure; n=2197 nondisclosure) and 3314 TWIST participants (n=1670 disclosure; n=1644 nondisclosure) completed survey items regarding the randomly assigned vignettes. The majority were willing to undergo ARVRT regardless of which vignette they saw (1670/2151, 82.7% [AMIS] and 1326/1670, 80.8% [TWIST] in the disclosure group; and 1399/2197, 68% [AMIS] and 1101/1674, 68.45% [TWIST] in the nondisclosure group) after later learning about public health uses of ARVRT results.
The majority of respondents expressed willingness to undergo ARVRT even with disclosure of public health uses of these data, but willingness markedly decreased when learning about these uses after the fact, highlighting the importance of transparency in MHS programs. Accordingly, in line with the ethical principle of respect for autonomy and the likelihood that the potential public health benefits of MHS programs will not be compromised, consideration should be given to encouraging clinicians to disclose public health uses of ARVRT at the time ARVRT is recommended.
分子HIV监测(MHS)可用于帮助识别和应对迅速传播的HIV感染新集群,这种做法称为集群检测与应对(CDR)。在美国,MHS依赖于从常规临床抗逆转录病毒耐药性检测(ARVRT)中获得的HIV基因序列。根据法律,ARVRT结果会上报给公共卫生机构用于MHS,且未要求个人对此给予明确同意。这种做法引发了伦理问题,包括对这些临床数据用于公共卫生用途缺乏同意以及缺乏透明度。此类担忧引发了辩论,并可能对HIV感染者在临床建议时同意进行ARVRT的意愿产生寒蝉效应,危及基于MHS的HIV预防工作的效用。针对MHS缺乏对ARVRT结果用途的常规披露,2022年,总统艾滋病咨询委员会(PACHA)发布了一项决议,呼吁美国疾病控制中心“要求医疗服务提供者向患者解释MHS/CDR以及在这些监测活动中收集和使用的实验室检测结果”。
本研究旨在探讨临床医生披露ARVRT结果用于MHS的公共卫生用途与不披露相比,对患者接受推荐的ARVRT的意愿的影响。
我们进行了一项随机调查实验,研究临床医生披露ARVRT结果用于MHS的公共卫生用途与不披露(当前的护理标准)以及随后通过“可信媒体来源”发现此类用途对患者接受推荐的ARVRT意愿的影响。研究参与者是美国每年进行的两项全国性网络调查之一的受访者:美国男性互联网调查(AMIS)和跨性别女性互联网调查与检测(TWIST)。
总体而言,4348名AMIS参与者(n = 2151名披露组;n = 2197名非披露组)和3314名TWIST参与者(n = 1670名披露组;n = 1644名非披露组)完成了关于随机分配的 vignette的调查项目。在后来了解到ARVRT结果的公共卫生用途后,大多数人无论看到哪个vignette都愿意接受ARVRT(披露组中1670/2151,82.7%[AMIS]和1326/1670,80.8%[TWIST];非披露组中1399/2197,68%[AMIS]和1101/1674,68.45%[TWIST])。
大多数受访者表示即使披露这些数据的公共卫生用途也愿意接受ARVRT,但在事后了解到这些用途时意愿明显下降,这突出了MHS项目中透明度的重要性。因此,根据尊重自主权的伦理原则以及MHS项目潜在的公共卫生益处不太可能受到损害的可能性,应考虑鼓励临床医生在推荐ARVRT时披露其公共卫生用途。