Molecular HIV surveillance (MHS) is used in public health to help identify and respond to clusters of rapidly spreading HIV transmissions, a practice known as cluster detection and response (CDR). In the United States, MHS relies on partial HIV gene sequences obtained from antiretroviral resistance testing (ARVRT) performed during routine clinical care of people living with HIV [1]. As opposed to time-space clusters that rely on the identification of an increase in new HIV diagnoses in a geographic area, MHS/CDR uses ARVRT data to identify emerging clusters of highly similar HIV sequences, which is an indicator of rapid HIV transmission [2]. Research has demonstrated that rapidly growing clusters contribute disproportionally to new HIV infections [3]. The use of MHS/CDR allows health departments to direct and prioritize resources toward groups experiencing rapid HIV transmission [2].

In the interests of public health and as is the case with other reportable conditions, ARVRT results are reported to public health agencies for MHS and individuals are not asked for their specific consent to do so. In 2018, the US Centers for Disease Control and Prevention (CDC) mandated that health departments include MHS in their CDR procedures; and in 2019, the use of MHS for CDR was identified as a pillar of the US Ending the HIV Epidemic initiative [4].

While difficult to quantify, the CDC has cited beneficial results of using MHS for CDR, including reduction in new HIV diagnoses, improved HIV testing and diagnoses, increased pre-exposure prophylaxis uptake, expanded syringe services program use, and improved linkage to care [5-7]. Nevertheless, current practices regarding such uses have raised ethical and social concerns regarding disclosure, consent, privacy, stigma, and the potential for HIV-related criminal prosecution [8-11]. Critics have argued that the identification of individuals in transmission clusters for intervention and prevention services, and the publicity surrounding those networks, could potentially further increase stigma and legal risk for marginalized individuals and groups including people of color, sex workers, and those already subject to enhanced policing and surveillance [12,13]. Several advocacy organizations have opposed using MHS for CDR [12,13], with some calling upon the CDC to halt its use altogether [14], citing concerns that the personal and medical information of people living with HIV are being used for surveillance purposes without meaningful engagement of people living with HIV in program planning, individuals’ knowledge about how their ARVRT results are used in surveillance activities, and lack of informed consent. In response to these concerns, the Presidential Advisory Council on HIV/AIDS (PACHA) passed a nonbinding resolution in 2022 calling for substantial action by public health agencies and others, including the need to meaningfully engage with communities regarding MHS to minimize harms associated with its implementation, to gather evidence concerning its use, to obtain consent for it, to review criminal and public health laws that disparately treat people living with HIV, and to address punitive laws related to HIV criminalization [15]. To deal with the lack of transparency surrounding the use of clinical ARVRT results for MHS/CDR, the resolution called upon CDC to “require that providers explain MHS/CDR and the laboratory test results that are collected and used in these surveillance activities to their patients” [15].

While use of MHS continues to spur vigorous debate, to date there has not been a systematic assessment of how the risks and benefits of MHS are perceived among people living with HIV and people without HIV at increased risk of acquiring it. If left unidentified and unaddressed, these perceptions and risks could conceivably have a chilling effect on the willingness of people living without HIV at increased risk to pursue HIV testing and people living with HIV to agree to ARVRT when recommended clinically as well as decrease trust in both the health care system and public health.

To this end, our multidisciplinary team is conducting a mixed-methods, multiphase research project titled, “Study of Ethics and Stakeholder Attitudes towards Molecular Epidemiology (SESAME)” to collect data from a wide range of stakeholders to inform developing policies and practices.

In this report, we describe the results of a randomized survey experiment examining the effect of clinician disclosure of the public health uses of ARVRT results for MHS versus clinician nondisclosure and subsequent discovery of such uses through a “trusted media source” on patient willingness to undergo recommended ARVRT.

In this study with GBMSM and transgender women or transfeminine persons from across the United States, majorities of both study populations were willing to undergo ARVRT recommended by an HIV care clinician regardless of the requirement for public health reporting of those test results and the manner in which they learned about the reporting requirement. Despite these majorities, however, our results show that disclosing the public health reporting requirement to patients at the time ARVRT is ordered resulted in significantly higher willingness to pursue ARVRT than subsequently finding out about this reporting requirement from a “media story.” The disclosure-related disparities in willingness to pursue ARVRT were most evident among transfeminine persons who were Black or who were living with HIV infection.

Importantly, our data suggest that informing patients upfront that ARVRT results are shared with public health authorities has only a modest effect on ARVRT uptake. Higher levels of ARVRT uptake were reported among nondisclosure vignette respondents when asked before learning about the public health reporting requirement through the “media story” and, thus, when they were “unaware” of the reporting requirement. However, when those in the nondisclosure group later learned of the public health reporting requirement from a media story, their subsequent willingness to pursue testing dropped significantly, far below the level reported by those who were informed by the clinician at the time of testing (disclosure group). This steep drop in willingness to pursue recommended ARVRT among those in the nondisclosure group is not surprising and is likely attributed to respondents’ learning that their ARVRT results were shared with public health authorities without their knowledge.

Critics of MHS have advocated for incorporating informed consent into sharing ARVRT data with public health authorities for MHS, citing a lack of transparency about the process and concerns about individual privacy and autonomy. In their 2022 resolution PACHA urged “CDC to work with states and jurisdictions, alongside community members, providers, tribes, tribal epidemiology centers, members of networks of people living with HIV, and partner agencies within HHS to create a stronger system of informed consent around the uses of molecular HIV data” and called upon CDC to require states to “provide plain language notifications to individuals living with HIV on the types of surveillance and analyses being conducted and opt-out options for the use of MHS patient data for CDR activities” [15]. Nevertheless, while CDC’s recently updated HIV CDR Guidance for Health Departments includes calls for public health practitioners to be more transparent about the use of MHS, it does not endorse waivers or opting out of it [19].

In the absence of informed consent or an opt-out option for sharing ARVRT results with public health agencies for MHS, our data suggest the potential value of simply disclosing the public health use of ARVRT results to people living with HIV, preferably at the time testing is recommended. While disclosure is not equivalent to obtaining informed consent, upfront disclosure about public health reporting may resolve some of the ethical and community concerns regarding the lack for transparency about how personal data are used in MHS/CDR without jeopardizing the potential public health utility of MHS-informed HIV prevention efforts.

These findings also align with results from an earlier survey we conducted as part of our SESAME project where we examined 2 methods for explaining MHS to MSM living with HIV and those at-risk without HIV in the 2021 AMIS survey. Specifically, participants were randomly assigned to view a brief video or text explaining MHS. In the video group, respondents with high video engagement were less likely to be concerned about MHS; and in the text group, discomfort with MHS decreased as awareness of different public health activities increased [20].

The results of our study should be interpreted with some limitations in mind. First, while responses to hypothetical vignettes can be informative, it is unknown how well the findings translate to real-world situations. For example, we do not know why some participants in both arms of the study declined ARVRT testing at the time of their visit with the clinician. Clearly there were other factors at play besides the disclosure of public health use of these test results. Ideally, future demonstration projects in actual situations could assess the impact of disclosure on willingness to undergo ARVRT. In addition, unmeasured contextual factors may play a role in real-world decision making, but it is unlikely such factors would bias the results given randomization. Although the vignettes were simple, there may have been differential understanding of them based upon the vignette type. Of note, to overcome this possibility, we conducted extensive cognitive testing of the scenarios (as well as the response options) before fielding them.

Furthermore, AMIS and TWIST are online convenience sampling surveys and results are not generalizable to all people living with HIV and those without HIV at increased risk of acquiring it. The convenience sampling approach, even though conducted with multiple types of websites and social networking applications intended to increase sample diversity, increases the potential for selection biases and in ways that cannot be directly measured. Racial and ethnic minority persons in both AMIS and TWIST and younger persons in AMIS were also substantially underrepresented, potentially reducing our ability to discern key differences among these groups.