Keywords

Public Health Ethics Issue

Emergent technologies create innovativetechniques and new insights that hold great potential for improving human life but also can disrupt the status quo. ELSI refers to the ethical, legal, and social implications that can attend these disruptions (Gannett 2019; Greenbaum 2013). One such emergent technology is molecular HIV epidemiology, which medical researchers and epidemiologists have framed in terms of ELSI challenges (Coltart et al. 2018; Mehta et al. 2019). The use of HIV molecular sequences has emerged as an approach to identify clusters of rapid HIV transmission. The use of this technology has raised concerns among HIV advocacy groups and has ethical implications for HIV practitioners.

Viral genetic sequences are generated as part of clinical care to identify potential drug resistance and determine the appropriate drug regimen to treat people with HIV. Public health practitioners analyze these sequences, reported routinely through surveillance systems as part of disease reporting, to identify and respond to clusters of rapid HIV transmission. The ethical, social, and legal implications of this work have arisen against the backdrop of HIV stigma and amidst efforts to build trust with the HIV community.

HIV stigma follows an historic pattern of “othering” people or groups in marginalizing ways that create or increase inequalities (Powell and Menendian 2016). HIV disproportionately affects persons marginalized because of racism, homophobia, transphobia, or other socially stigmatized behaviors, including some deemed criminal (e.g. injecting drugs or engaging in sex work) (Whetten et al. 2006; Arias et al. 2015; Bogart et al. 2019). Many groups disproportionately affected by HIV have experienced historical harms and negative personal experiences when engaging with government programs and medical systems, posing challenges to building and maintaining trust. (Whetten et al. 2006; Arias et al. 2015; Bogart et al. 2019). These compounded effects of HIV and other stigmas result in barriers to care, potentially increase mental and general health issues, and further the feeling of being “less-than” or outside of regular society (Brinkley-Rubinstein 2015).

Additionally, funding for HIV programs indirectly depends on the good will of the larger public, which initially ignored HIV (Padamsee 2020). Several years of work by advocates and public health agencies – including social marketing campaigns and activism with news media – changed the narrative around HIV and led to increased public understanding that anyone could acquire HIV and consequent increases in funding and resources (Brier 2009). Public support for funding relied, then, on enlightened self-interest, the idea that treating people with HIV also protected the broader public, a strategy that also aligns with a public health perspective. However, addressing ongoing HIV disparities will require a focus on the needs of people with HIV and the social, structural and contextual factors that disproportionately affect their communities (McCree et al. 2016). To people with HIV, a focus on protecting the general public from HIV can seem to downplay the recognition that people with HIV are already experiencing harms; it is akin to telling a Black Lives Matter advocate that “all lives matter” (McClelland et al. 2020; Nelson 2020). Suggesting that society needs to be protected from HIV (and by extension, people with HIV) can seem more like a subtle form of othering than a strategy to build trust (Center for HIV Law and Policy 2019; Kempner 2019). Instead, public health practitioners and clinical practitioners can extend dignity and respect to people with HIV as autonomous persons, to ensure that people feel they are within the “circle of human concern,” thereby fostering collaboration and building trust (Powell and Menendian 2016).

Another challenge to building trust relates to the use of emergent technologies, which alter our activities and environment in ways that foster progress but also disrupt the status quo, including its ethical and legal landscape (Greenbaum 2013). Concerns about the use of HIV sequences have arisen amid the broader context of increasing data collection by public health and national efforts to improve data quality information technology. Big data, artificial intelligence, algorithms created by machine learning, and the use of social media are transforming the potential of data collection both to promote health and to encroach on privacy (Zuboff 2019). This new era of technology necessitates that public health agencies empathically consider how the communities they serve will react to such disruptions and more specifically to privacy concerns. Molldrem and Smith (2020) have called for a framework of “HIV data justice” through which to consider HIV cluster detection and response. Although the number of individuals potentially adversely impacted by the release of public health data may be small in relation to the benefits of cluster detection in HIV prevention and control efforts, community concerns about expanded data collection, together with lack of control over the collection of personal health data and perceived lack of communication about it, risk undermining trust and reinforce the belief that government and medical systems are putting them in harm’s way.

The sensitivity of HIV data, specifically HIV molecular sequences, raises ethical concerns related to autonomy, specifically to the confidentiality of one’s medical information. HIV sequence data is often considered more sensitive than many other types of viral sequences, for several reasons. First, in the human body, HIV viral sequences are converted from RNA to DNA and become integrated into the genome of people with HIV, leading to challenges finding a cure (though it can be well-controlled) and raising concerns that do not arise with more transient viral infections (Maldarelli et al. 2014). HIV has historically been more stigmatized than other viral infections, such as influenza, leading to a range of discriminatory actions. In addition, concerns about non-public health uses of HIV data (i.e. as evidence in criminal proceedings) are rooted in the fact that people with HIV can be prosecuted for, or face steeper charges because of, their HIV status. Many states have laws that criminalize or control behaviors that can potentially expose another person to HIV, often including behaviors with effectively no risk of transmitting HIV, like spitting and having sex without disclosing HIV status while virally suppressed (Centers for Disease Control and Prevention2020a). Other states that do not have specific HIV laws prosecute people with HIV on similar grounds under more general charges, such as assault, or under more general infectious disease laws. In many states, law enforcement officers or prosecutors can request and often obtain – via a court order or subpoena – data on diagnosis, viral load, and other private information (Galletly et al. 2014, 2019; Lazzarini et al. 2013). The degree to which people with HIV are prosecuted under these types of statutes varies widely by state and local jurisdiction, and health department policies play an important role in protecting data (NASTAD 2018).

Several high-profile HIV criminalization cases have raised concerns about these laws among advocates for persons with HIV (Young 2012; Tien 2019). In the same timeframe, the collection and use of molecular HIV data in health departments has expanded, amplifying concerns about the potential use of these data as evidence in HIV transmission cases. The convergence of these issues has galvanized advocates to push back against both HIV criminalization and collection of HIV sequence data. Advocates for people with HIV have called for better data safeguards and greater transparency about the implications of drug resistance testing (Ryan 2018; Center for HIV Law and Policy 2019; Kempner 2019). Advocates are concerned about the potential for criminal and immigration systems to obtain such data from health departments and use it as evidence in criminal justice proceedings or as a basis to disallow immigration (Chung et al. 2019; Ayala et al. 2019; Spieldenner 2020; The Legacy Project 2019; Ryan 2018). Concerns about the potential for these non-public health uses of data held in health departments could have adverse public health implications. For instance, individuals concerned about lack of privacy might avoid seeking testing or follow-up care or might not disclose HIV status to medical providers.

To understand how molecular HIV cluster detection has exacerbated existing ethical and legal challenges, we need to explain how and why molecular HIV sequences have been generated as part of medical care. We also describe the evolution of the use of the sequences from clinical care to their use as a new public health tool.

Background Information

Surveillance, the process of continuously and systematically collecting health-related data, is a core component of public health (World Health Organization2020; Centers for Disease Control and Prevention2018). Public health relies on these data to set policymaking priorities, to alert agencies to emerging threats, and to plan, implement, and evaluate programs. Careful consideration of the ethics of public health surveillance helps agencies responsibly implement programs and activities, maintain trust with communities, and balance individual and community perspectives and concerns (World Health Organization2017).

In the United States, public health agencies have the legal authority and duty to collect and report HIV data for public health purposes from medical and laboratory records. These data are collected without informed consent for the greater societal good to address public health needs, in accordance with the Common Rule (World Health Organization2017; Lee et al. 2012). Nevertheless, collecting individual-level public health surveillance data frequently raises concerns regarding individual privacy and consent. These concerns are heightened regarding HIV surveillance, because of the stigma and discrimination persons with HIV often face (Fairchild et al. 2007).

CDC, state, and local health departments began collecting data on the syndrome that would later be called AIDS in 1981, and later, on HIV diagnoses and treatment (Centers for Disease Control and Prevention2019). Many states delayed adoption of reporting of HIV diagnoses because of public concerns around confidentiality and privacy, especially with regard to name-based reporting. Because few effective treatments were available early in the epidemic and the risks of stigma and harm were great, the potential harms of collecting this information outweighed the benefits. Once effective anti-retroviral treatment (ART) became available, the balance began shifting in favor of the benefits of collecting more individual-level information, including names.Footnote 1 As state and federal HIV surveillance systems have evolved in scope and technical sophistication, CDC has periodically considered the ethical implications of these developments, including recently for molecular HIV cluster detection and response (Sweeney et al. 2013; Lee et al. 2012; Centers for Disease Control and Prevention2020b).

Molecular HIV cluster detection and response activities use HIV genotype sequences routinely collected as part of clinical care and public health surveillance to detect very similar HIV sequences. Because HIV evolves over time, changes in the genetic sequence of HIV produce different strains which can sometimes develop drug resistance. To identify appropriate medications for people with HIV and to monitor drug efficacy, clinicians order drug resistance tests, which generate viral genetic sequences (Gunthard et al. 2019). By collecting and analyzing these sequences, public health agencies can identify groups of very similar HIV strains, which alert the agency to possible rapid transmission and provide opportunities to highlight and address gaps in public health programs. However, cluster analysis also includes highly sensitive information about modes and patterns of transmission, risk behaviors, and the demographics of partners. Detection of a cluster neither implies that persons involved have transmitted HIV directly nor provides conclusive information on the direction of transmission, but suggests common transmission links, whether direct or indirect (e.g. a third person transmitted to both or was the intermediary). Perhaps more importantly, these clusters shed light on much higher HIV transmission rates compared to baseline rates (Oster et al. 2018). Public health practitioners can use this information to identify and address gaps in public health prevention programs.

Approach to the Narrative

This narrative explores several issues related to HIV cluster detection and response. These include the lack of individual consent for HIV surveillance, the collection of HIV genotype data, and the use of these data for beneficial public health purposes. Moreover, the potential use of these data for non-public health purposes also underscores the need for transparency. These potential uses, and concerns about these uses, are likely to disproportionately impact marginalized populations. The characters in the narrative – public health agency staff and people with HIV – portray these issues from various, sometimes opposed, perspectives. The narrative also illustrates how common ground can exist between groups in relation to ethical concerns that arise within the context of traditional public health activities. These activities include public health focusing on population-level interventions rather than on individuals, partnering with communities, and establishing trusting relationships with them.

The following fictionalized narrativesFootnote 2 portray a response to an HIV outbreak, first through an email interaction between staff members at two different health departments (Chris and Maria), and then through an online exchange on a public blog post between people with HIV and HIV advocates (Alex and Perry). The choice of the email and blog formats is twofold: one, to demonstrate the existence of narratives in the daily interactions of public health workers and activists that can be sources of ethical insight; two, to highlight the fact that these methods of communication can be ways for both groups to actively incorporate different perspectives into their own rhetoric surrounding the issue. The agency perspective prioritizes preventing HIV transmission and reflects a utilitarian focus on the balance of benefit and harm. The community perspective reflects an ethics of care that focuses on the client’s community, an HIV-support network, and the potential harms associated with public health interventions. We have attempted to express the language in the vernacular that persons in these roles might use on these communication platforms. It should be noted that not all of the discussion in the narrative aligns with CDC or health department science or terminology, but rather is presented with an intention to convey how these conversations might unfold under informal circumstances.

Both conversations discuss a cluster of rapid HIV transmission among men who have sex with men (MSM) in a small midwestern town. The health department has identified a group of men who share similar HIV genotypes, suggesting rapid transmission. CDC and the state are working with local health departments to respond to the situation as quickly as possible, to prevent continued transmission that might result in an eventual outbreak. This robust public health response does not go unnoticed in the small community, and people start to talk; a local news station even airs a story about the “outbreak”. Many in the community are learning about HIV prevention and surveillance systems for the first time, and some are alarmed. These fictionalized accounts derive in part from previous discussions and online conversations, such as the HIV/AIDS Network Coordination webinar series on HIV Genetic Sequencing,Footnote 3 CDC’s virtual meeting series on Responsible Use of HIV Cluster Data for Public Health Action,Footnote 4 and the Center for HIV Law and Policy’s webinarFootnote 5 and documentsFootnote 6 on the topic. The reader is encouraged, while absorbing these pieces, to call upon examples from their own professional and personal careers that could benefit from the recognition of alternate perspectives and narratives.

Narrative

Emails Between Chris and Maria: Staff Members at Different Health Departments

Hi Maria,

Did you hear about the MSM HIV cluster over here? Very challenging; it’s been keeping us real busy. We need to get the transmission rates under control, fast. It’s starting to create some panic and the governor’s office keeps wanting to know how many new cases have been diagnosed. I’d love to walk you through what we’re already doing and pick your brain for some advice on how to address it.

We’re setting up testing sites in neighborhoods where men hook up. That’ll help identify the positives, and then we’re referring people to treatment or to PrEPFootnote 7 depending on their test results. We’re also trying to get local CBOsFootnote 8 to set up testing and education on their end. My boss is meeting with folks at the hospital to push their emergency unit to start routine testing. That’s about it. I’m hoping our weekly case counts start leveling off soon, but with the big increase in testing, that might not happen. We just don’t know how many cases are out there.

What’s driving me crazy and prompting me to write to you is the pushback we’re getting from the community. They’re suddenly upset we’re collecting their personal data – we’ve been doing it for years! At some of the meetings we’ve had with community groups, we’ve been getting wild comments, like “you’re collecting our names and blood samples without our permission,” “you’re tracking us behind our back,” “next you’ll be quarantining us!” Consent for research is on everyone’s radar now, so they don’t get it that we don’t need their consent to collect data to monitor disease. I’m sure they’d be complaining just as loudly if we weren’t collecting data and some outbreak caught us by surprise. Then they’d all be screaming if we actually made them come in to sign off on including their data for surveillance.

But now I’m just grumbling. I mean, sure, I agree that people have the right to control what goes on with their personal data (that’s why I don’t use social media), but we’re in the middle of trying to contain this disease. We can’t just give veto power on everything we do to the few people who don’t want the government to have their lab results. We’re open to any solution that everyone can live with, but right now nothing we say or do seems to pacify some of these folks. Meanwhile we have our work cut out for us dealing with the disease and that’s our priority.

How have you handled these types of sticky situations before?

Looking forward to your response,

Chris

  • ~

Chris,

Hello. Looks like you have quite the situation. Glad you reached out and am assuming you know I’ve had similar experiences working with communities toward win-win solutions for all involved. Getting them to understand the why and how of HIV sequences is a real challenge! Literally every term involved sounds stigmatizing or triggers some scary thought… “molecular,” “surveillance,” “cluster,” etc. – we’re even doing focus groups now to try and figure out the best way to explain all this!

To address HIV, we need input from people involved, so we can understand what’s going on when people are acquiring HIV really quickly. I think that’s just it – we have to work with communities instead of just on their behalf. Everything you’ve said is from a public health agency perspective, which is fair, because it’s where we sit. Every. Single. Day. (By the way, did you ever get that window office? I did not… ) Our work comes from a place of desire to help others, which is extremely important. But we have to also realize that you and I will never be able to really understand the fear and stigma associated with having HIV. For example, some of your language (“identify all the positives” or “stop the spread of disease”) sounds stigmatizing for many people with HIV. I sincerely hope you don’t speak like that at community meetings. I know we want what’s best for the community’s health, but sometimes our language sounds like we only care about stopping transmission.

I’ve been around long enough to remember the early days, when we didn’t have good treatment available, so we funded community support groups. We don’t do that anymore because we just expect people to take their meds. While our biomedical advances are wonderful, focusing on HIV without a focus on people with HIV is part of our problem. Yes, medical advances have made HIV a manageable condition nowadays, but there are still a LOT of issues – lots of people have never heard of PrEP, or don’t believe HIV medications are effective or affordable, for example. General practitioners aren’t always comfortable prescribing PrEP, but people need PrEPbefore they get HIV, so they can’t just go to the infectious disease doc. I’ve heard recent stories of teenagers who have been kicked out of their houses when their parents found out they were diagnosed, not just because of HIV, but because they were gay. Not to mention the side effects of the medications people have to take, and the cost of meds and visits for lab work, check-ups, time off work, etc. Remember when you came back from your mission trip with malaria? Can you imagine having to deal with something like that for the rest of your life?

We want to make sure that as many people as possible understand why we’re doing what we’re doing, and if we’re talking down to them, they probably won’t listen. We also need to reassure them about how well-protected their data are, so that they continue to seek medical care and aren’t so afraid of being “tracked” that they forego treatment and testing. As you said, our number one goal is to “stop HIV” but where are the “people” in that goal? For people who already have HIV, we need to stop it from progressing, which helps them and also helps stop transmission. We don’t want to scare people away from getting tested or treated. Besides, we really need the community’s input to help us figure out what is going on. Let’s face it… some people are never going to want to come to the health department. We need to be working with folks in the community to help us figure out how to reach people in the way that is right for them.

I think we both know that molecular cluster detection and response can be incredibly useful, but to be honest, we got off to a rocky start here with our community groups because we didn’t introduce it early on or involve them in how we rolled it out. Listening to their concerns and criticisms takes longer up front, for sure, but it’s really important because it will help us create a better and more effective public health program in the long run. And yeah, you might never see perfectly eye-to-eye with some folks, but it’s still really important to hear them out and try and understand where they’re coming from.

I encourage you to think about the issue from another viewpoint other than the one with which you’re comfortable. We can all benefit from multiple perspectives.

Thanks for reaching out and for being open to new thinking on the issue. I hope you all are able to figure out a solution quickly. Happy to talk more.

Sincerely,

Maria

Blog Posting Between Alex and Perry: Advocates for People with HIV

  • Blog Post #44 – Consent Concerns and Sneaky Surveillance: Alex

Hi, new and old readers, and friends! As most of you know, I started blogging a few years ago to talk about my diagnosis with friends and family, and my readership grew exponentially (not sure if that’s a good thing or a bad thing!!). You’ve been following my dating escapades, my struggles with doctors and insurance, and my journey from scared, ashamed kid in the HIV clinic to proud and empowered advocate. I think of myself as being pretty well informed about HIV, so I was stunned when the health department had a press conference about an HIV outbreak here. While I was saddened for all the gay men finding out they’re now HIV-positive, I was also shocked that there was a new surveillance system that uses my blood from lab testsFootnote 9 without my consent. Just last year, we had an activist speak at our World AIDS Day event about HIV criminalization. He had been put in prison for close to two years because his ex claimed he did not disclose his HIV status. With this new system, could any of the people I’ve met online use this against me? What if a relationship doesn’t work out, and someone decides to get revenge by saying I didn’t disclose my status? Could this happen to me or my friends? I didn’t know what else to do but blog about it.

I pride myself on being involved. Ever since I was diagnosed, I have shared my journey, my hopes and fears. You read about my first date with Coffeehouse Bear – how scared I was to tell him I had HIV, and how awesome he was about it when I finally worked up the courage. Then, I told you about how crushed I was when we broke up. But thanks to your support and advice, I got back out there. Now I’m on the apps and meeting new guys … So, what if I don’t tell them about my HIV? I mean – I do, but… I’m undetectable, so do I really have to say anything? Don’t they have some responsibility to protect themselves? There’s PrEP, and condoms, and all sorts of other ways of reducing risk… In this state, if I don’t disclose, I’ve committed a felony. But how do they prove it? They don’t. The legal burden is on me to prove I disclosed (maybe I should text them my blog? Or screenshot our Grindr chats?? ).

Since I learned about this law, I’ve gotten a little more nervous meeting new guys. Imagine my surprise to find out that on top of that, our health department has a new way of tracking us, one they’ve been using for over a year without informing us. I’ve seen it called Molecular HIV Surveillance,Footnote 10 although now I think they’re using a new name, and it’s how they figured out the recent HIV outbreak here is all related.

Now when blood is drawn for HIV testing or treatment, the labs that process the samples report genetic information about my HIV to health departments and the CDC. They say it’s for clinical reasons, to find out if I am developing resistance to my meds. But with so many people prosecuted for HIV, even when they didn’t transmit, do we really want states collecting this type of information and risking more legal repercussions? Do the police get access to this data? What about the FBI or ICE? We should all think twice before letting our doctors run these tests.

The health department has implemented this new system without consulting us, the people living with HIV most affected by it. Haven’t we learned from the early years of ACT UP that the voice of people living with HIVmust be central to HIV services? Don’t they remember, “nothing about us, without us”?? I DEMAND that the health department get feedback from all of us before continuing this potentially damaging and invasive surveillance system, ESPECIALLY in this state where people are in prison for (supposedly) exposing others to HIV (even for things like spitting at a cop, not even sex or drugs).

And, while I’m uncomfortable with the amount of data that’s being collected, as a “gainfully employed” white gay guy, I can’t imagine what this is doing to other folks with less privilege than me. Case in point: I recently heard news of an HIV outbreak among people who inject drugs in the town where I went to college. Most of the folks involved are experiencing homelessness or unstable housing, and the community there is, shall we say … less than understanding (in the middle of this outbreak, there’s a woman posting live feeds of people coming out of the needle exchange on a local Facebook group…). I’m worried for myself but I’m really talking about this because I fear what this additional surveillance will do to people who are more stigmatized, and less resourced, than me.

  • ~

  • Blog response: Perry

Hi Alex! I appreciate the work that you do. I’ve followed your blog for a long time – for my friends who are newly diagnosed, it has been a real life saver. Thank you!!

I do have to say, when I read this piece, I couldn’t help but think that you might be presenting a “worst-case scenario” that could alarm people. I would hate for people to stop seeing their doctor and getting the medical care they need to thrive with HIV. You and I are undetectable,Footnote 11 so, for us, the healthcare system is working. And part of that system are our longtime allies at the health department, annoying and imperfect though they may be!!

When I was first diagnosed in the 1990s, I thought my life was over. Sadly, my partner only made it 3 years after diagnosis. It was the health department staff that helped connect us to support groups, and later, to clinics when better meds were available. Through the support groups and my doctors, I have been able to live longer than I thought possible. I see the health department folks at the Pride parade every year, and they put up PrEP ads in our town last year. I don’t think it’s fair to paint them as total enemies to our community. Maybe if we just reached out to them, they could figure out some way for people who have legitimate fears to opt out of some of the surveillance requirements? Maybe it’s naïve to think a conversation could change things, but surely, it’s a start?

I’m more worried about people with HIV who aren’t getting care, unlike us. I realize this is probably because of other challenges in their lives – I have a younger friend who got diagnosed, and who didn’t have health insurance. I gave him rides to the HIV clinic and helped him get enrolled in Ryan White,Footnote 12 but I can’t do that for everyone. I also worry about the kids who come from farm towns to the “big city” because they want to meet guys, and don’t really even think about HIV until they get diagnosed. How do we make sure everybody gets the same acceptable and affordable care that we have benefitted from? If we are a community, we need to think about the ones who do not get a seat at the table, not just ourselves.

Thanks for all you do!

-Perry

Questions for Discussion

Autonomy, confidentiality and consent, beneficence and nonmaleficence, transparency, and respect for persons are key ethical issues at the heart of the divide between advocates, people with HIV, and public health agency leadership and staff. Relative importance of the balance of potential benefits and harms to the individual versus the population presents another level of complexity for the use of sensitive personal data. Advocates often strive for outcomes that center around the needs of people with HIV, from a perspective centered on an ethics of care and justice (protecting the vulnerable, just distribution of resources).

Lastly, respect for persons is important to consider – the narrative of stopping a virus can often seemingly remove the needs of people with HIV from the story.

  1. 1.

    How do these two narratives illustrate similarities and differences in the ways the health officials and people with HIV or their allies consider these ethical issues?

  2. 2.

    Why does the involvement of viral genetic data increase community discomfort?

  3. 3.

    What ethical considerations should public health agencies consider when communicating about and implementing molecular HIV cluster and outbreak detection and response activities to the public?

  4. 4.

    How can public health agencies foster two-way communication with the communities they serve? What mechanisms would allow people with HIV to provide more input into programs that affect them?

  5. 5.

    How do public health officials recognize and address the authority and power dynamics presented in public health/community collaborations?

  6. 6.

    How can agencies and communities work together to establish and build trust? Can there ever be true partnership between agencies and community members?

  7. 7.

    How can this analysis provide insight into future initiatives and expansion of existing efforts?