Impact of Disclosing to Patients the Use of Antiretroviral Resistance Testing Results for Molecular HIV Surveillance: A Randomized Experiment in 2 National Surveys.

Background: 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." Objective: 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. Methods: 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). Results: 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. Conclusions: 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.