Advancing Dialogue About Consent and Molecular HIV Surveillance in the United States: Four Proposals Following a Federal Advisory Panel’s Call for Major Reforms

On October 17th, 2022, the US Presidential Advisory Council on HIV/AIDS (PACHA) adopted a nonbinding resolution about domestic molecular HIV surveillance and cluster detection and response (MHS/CDR) programs.¹ PACHA is the highest federal advisory body on matters of HIV/AIDS policy; its membership includes people living with HIV, civil society advocates, jurisdictional public health leaders, and other HIV stakeholders. MHS/CDR has been a core part of US HIV surveillance and prevention since 2018 and is the “fourth pillar” of the Ending the HIV Epidemic initiative launched in 2019.^2-4 MHS/CDR involves reusing clinical HIV genetic sequence tests for public health purposes.^3,5 HIV genotype tests are generally ordered by clinicians for people living with HIV upon entry or reentry into care. These data help clinicians prescribe appropriate medications by showing whether a person’s HIV is resistant to certain antiretroviral drugs.⁶ When HIV genetic sequence data—also called “molecular” HIV data—are sent to HIV surveillance systems operated by jurisdictional health departments, they can be analyzed using phylogenetic methods alongside other traditional forms of epidemiological data to reveal transmission dynamics among individuals. This public health work aims to quickly reveal unidentified “clusters” of recent transmission that can be targeted for outreach using interventions that are often framed using the rhetoric of “real-time.”^7,8 Proponents of MHS/CDR argue that the practice is beneficial because it is cost-effective, can rapidly identify clusters that traditional methods might not, and can assist with driving resources into transmission hot-spots.^3,5

Following outcry about MHS/CDR by networks of people living with HIV over concerns about program activities, the practice has been called into question and become controversial. Concerns expressed by advocates, ethicists, and scholars of HIV surveillance have included a lack of informed consent in HIV surveillance, issues related to bodily autonomy regarding the repurposing of clinical laboratory data for public health purposes, the potential to worsen institutionalized forms of racism in the United States through extracting data from disproportionately affected communities of color, a lack of demonstrated benefit, and how CDR might intersect with HIV criminalization.^9-12 2018–2023 has seen protests, comments sent to federal agencies, concern from some health department staff,¹ calls for a moratorium on MHS/CDR, and debates in the public health, policy, and ethics literatures to which we have contributed.^9,10,13-21 However, other voices in the field have argued in favor of the practice, ranging from ethicists who have endorsed the benefits of these programs and characterized MHS/CDR technologies as simply “old wine in new bottles”¹⁹ to public health practitioners who advocate for its utility in addressing HIV/AIDS epidemics^{.5, 7,8}  Others take a mixed view and argue that the benefits and risks are uncertain or call for greater research into MHS/CDR programs in order to understand how they can benefit people living with HIV (especially people who are not yet diagnosed).^22-25 The MHS/CDR controversy came to a head when PACHA convened a workgroup on the subject in May 2022—in which the first author participated—and then in October 2022 passed its resolution calling on the US Centers for Disease Control and Prevention (CDC) to require local MHS/CDR implementation considerations and other reforms. These include establishing MHS/CDR-specific community advisory boards, requiring jurisdictions to conduct MHS/CDR cost benefit analyses, and other requests.¹ In part, the resolution “urges 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.”¹ It also asks the CDC to “[r]equire that states 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.”¹

Here, we consider what this recent development means for the future of MHS/CDR in the United States and make four policy recommendations aimed mainly at federal stakeholders. We focus our analysis on matters related to consent, opt-out affordances, and plain-language notifications because we believe that these are the most technically challenging elements of the resolution. These aspects are also potentially the most transformative parts of the resolution because they call for a rethinking of how HIV surveillance and prevention should take place in the era of digitized public health systems, integrated HIV data infrastructures, and routine uses of molecular epidemiology in public health programs. We operate from the premise that new digital health systems and the introduction of pathogen genomics and big data methods into routine practice raise questions about appropriate data uses related to privacy, confidentiality, autonomy, and the right for individuals to be informed that prompt a collective rethinking of traditional public health frameworks that do not require individual consent for infectious disease control programs.^20,22,26,27

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References

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