How is the Expert Consensus Statement bringing science to justice?

Two years ago this month saw the launch of the Expert consensus statement on the science of HIV in the context of criminal law (Expert Consensus Statement) at a press conference during AIDS2018 in Amsterdam, published in the Journal of the International AIDS Society (JIAS), and translated into French, Russian and Spanish.

Authored by 20 of the world’s leading HIV scientists, and endorsed by more than 70 additional expert scientists, as well as IAPAC, IAS and UNAIDS, the Expert Consensus Statement described current evidence on HIV transmission, treatment effectiveness and forensics so that HIV-related science may be better understood in criminal law contexts.

The Expert Consensus Statement was the end result of a multi-year process developed by a partnership comprising the International AIDS Society (IAS), the International Association of Providers of AIDS Care (IAPAC), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the HIV JUSTICE WORLDWIDE Steering Committee.

The HIV Justice Network has now published an interim scoping report, written by HJN’s Senior Policy Analyst Sally Cameron, that explores the impact of the Expert Consensus Statement in the two years since its publication.

The report concludes that the Expert Consensus Statement is meeting both its primary aim (to support defence arguments in HIV criminalisation cases) and its secondary aim (supporting lobbying for law and policy reform) in many jurisdictions. But it also found that the process of developing and promoting the content of the Expert Consensus Statement has delivered additional benefits that further support advocacy efforts to end HIV criminalisation.

In summary, the Expert Consensus Statement is being used to:

  • Assist HIV criminalisation defence arguments and strategic litigation, changing courts’ understanding of transmission risks associated with HIV and the effectiveness of modern treatments.
  • Shape advocacy for law and policy reform, including mobilising stakeholders to lobby for reform, delivering law and policy reform, improving legal and judicial practice, facilitating community advocates’ access to government and judicial bodies, and gaining support from public health bodies and customary and religious leaders.
  • Inform scientific and medical thinking, including being cited in many peer reviewed articles and in scientific and medical press, being hosted on the sites of scientific/medical/academic organisations, and being ranked the #1 JIAS article to date.
  • Develop stronger relationships that cross silos and advance capacity, enabling efficient and informal communications between partners to rapidly move projects forward, with Expert Consensus Statement authors supporting community organisations by assisting in defence cases, answering ad hoc questions and co-authoring abstracts, presentations and articles.
  • Disseminate accurate, positive messages about people living HIV and the issue of HIV criminalisation, including facilitating keynote addresses and presentations at notable conferences and meetings, and generating global mainstream, community and social media. Ultimately, interest in the Expert Consensus Statement has elevated the global conversation about HIV criminalisation, with co-ordinated messaging translating into a powerful positive narrative in many sites.

 

US: Activists activists raise concerns over the links between public health & law enforcement surveillance

Questioning the Benefits of Molecular Surveillance

Can this HIV prevention strategy overcome mistrust and fear among marginalized communities?

In Texas, health officials recently used a new surveillance technology to identify a large HIV outbreak among gay and bisexual Latino men. In Massachusetts, officials used the same strategy to respond to an outbreak among injection drug users. And in California, researchers used the method to identify a transmission cluster among transgender women.

Led by initial proof-of-principle research at the Centers for Disease Control and Prevention (CDC), an HIV prevention strategy known as molecular surveillance is quickly expanding across the country. Since December 2015, according to an email from a CDC source who commented on background, the technique, based on sequencing and comparing individuals’ viral genetic blueprints, has identified more than 240 recent and rapidly growing HIV transmission clusters, the vast majority of which had not previously been recognized. Comparing these sequences allows researchers to determine whether individuals’ HIV is closely related, which offers clues about who transmitted the virus to whom. 

Traditional public health methods—now being used to trace the spread of COVID-19, the disease caused by the new SARS-CoV-2 coronavirus—largely rely on asking people about their contacts and getting in touch with them by phone or in person. The CDC source said molecular data analysis allows for more rapid and comprehensive cluster and outbreak detection and response. As such, molecular surveillance is seen by the agency as a key part of effective HIV prevention and a means to help hard-hit communities and the nation end the HIV epidemic.

Those idealized goals, however, are clashing with a far messier reality in which decades of mistrust and fear among marginalized communities, heightened in the current political climate, are coming to a head. The tech-aided HIV surveillance strategy, six activists told POZ, could open up new avenues for private data to be breached, exploited, subpoenaed or otherwise released through many of the HIV criminalization laws and statutes still on the books in 34 states.

Activists say the CDC-led molecular surveillance effort was launched with little or no consultation or buy-in from the communities most likely to be impacted. Several meetings ensued, including one convened in 2018 by the O’Neill Institute for National & Global Health Law at Georgetown Law School in Washington, DC, that allowed critics to air some of their concerns. Despite a subsequent round of CDC guidelines on how best to safeguard patient data, however, the controversy has only grown over the potential misuse and unintended consequences of the surveillance scheme.

Patients can’t opt out of providing their viral sequence data for the molecular tracking, critics point out. Nor does the strategy adequately consider the state-by-state patchwork of protections and penalties or the growing health implications of an erosion of immigrant, minority and LGBTQ rights, they say.

Sean Strub, POZ’s founder and the executive director of the nonprofit Sero Project, which focuses on reforming HIV criminalization laws, says he fears the CDC-led strategy will diminish trust and cooperation with public health agencies and drive more vulnerable people further from the health care system out of fear of surveillance. “I think the risk of unintended consequences is very great,” he says.

Strub and other activists see molecular surveillance as part of a broader trend in the “securitization of disease,” which is increasingly blurring the lines between the public health and criminal justice systems.

“We are potentially threatening people’s freedom just to get cleaner data, and I think it’s a clear ethical concern,” says Devin Hursey, a member of the Missouri HIV Justice Coalition and a board member of Blaq Out, a nonprofit advocacy group for Black queer and transgender people in the Kansas City region. “We can’t just look the other way or say we’re doing our best effort when we’re not really addressing that HIV criminalization still exists.”

The CDC source told POZ that the agency understands and has addressed many of the questions and concerns raised by community advocates. The CDC has strong data protections and security measures in place, the source said, and has worked for many years to provide guidance to states on reviewing and revising criminalization laws and ensuring data are well protected.

But Naina Khanna, executive director of Positive Women’s Network–USA, says the CDC hasn’t responded to specific questions about its data-sharing practices with other federal agencies, like the Department of Homeland Security and Immigration and Customs Enforcement (ICE). Khanna points out that the communities most impacted by HIV are also disproportionately affected by surveillance, policing and criminalization. “That’s extremely concerning when we think about how policing intersects with being a Black gay man or being a Latino gay man,” she says. In response, the CDC source told POZ that all HIV surveillance data are reported to the agency without names or any personal identifiers and are encrypted and protected by an Assurance of Confidentiality under Section 308(d) of the federal Public Health Service Act.

A New Surveillance Tool

When someone tests positive for HIV in the United States, a blood draw allows labs to sequence part of the viral genome, or its genetic blueprint, and use that to determine whether the virus contains mutations that might lead to drug resistance. This information can help doctors tailor the best HIV treatment regimen for each individual. But once the genetic sequencing is complete, health departments can access that data for molecular HIV surveillance. Specifically, they compare viral RNA sequences from multiple individuals to identify clusters of transmission. This is possible because HIV mutates over time; as a result, people with similar genetic sequences are more likely to have been infected around the same time as part of the same person-to-person chain of viral transmission.

Randy Mayer, MS, MPH, chief of the Bureau of HIV, STD and Hepatitis at the Iowa Department of Public Health, says the HIV resistance tests sent in by doctors around the state essentially provide his department with free surveillance data. “It’s something that we can use to try to improve our response that doesn’t really cost us anything,” Mayer says. “So from that point of view, it is cost effective.”

If a state-run computer program finds two or more individuals who share closely related viral sequences, it suggests that HIV might have passed between them or through a close intermediary. Spotting such clusters of transmission could help public health officials identify HIV-positive individuals and their close sexual or needle-sharing partners.

The surveillance approach has multiple potential benefits, researchers say. “This is just one more strategy in the toolbox of surveillance tools used to guide public practice,” says Nanette Benbow, MAS, research assistant professor of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine in Chicago. HIV transmission clusters identified through this method, she says, may represent only the “tip of the iceberg” of at-risk individuals, since the genetic information is available only for HIV-positive people who’ve been to a doctor and received drug resistance testing. Through contact tracing, though, public health officials can find other people associated with the cluster, contact them and offer them a range of care or prevention services, like pre-exposure prophylaxis (PrEP), if they’re not already receiving them.

Benbow says evidence suggests that the rate of HIV transmission within such clusters is much higher than that of transmissions overall, bolstering the case that public health agencies should focus on these clusters as significant sources of active viral transmission.

Some public health experts say the growth of surveillance is inevitable. “You’re not going to stop technology. All you can do is try to get it implemented in an ethical manner,” says Eve Mokotoff, MPH, managing director of HIV Counts, a consulting business based in Ann Arbor, Michigan, that assists with HIV surveillance.

Andrew Spieldenner, PhD, vice chair of the U.S. People Living with HIV Caucus and an assistant professor of communications at California State University San Marcos, rejects that argument. “Just because technology exists doesn’t mean we have to use it,” Spieldenner says. “We have to balance it with the harms it does to individuals.”

Newer technology that could extend molecular HIV surveillance is giving activists more pause. One method, called ultra-deep whole-genome next-generation sequencing, isn’t yet part of the CDC strategy. But emerging study data suggest that it could predict the directionality of linked HIV transmissions, potentially adding new evidence to suggest who infected whom. Researchers at Johns Hopkins University School of Medicine, in fact, recently described how they correctly predicted HIV transmission from an index case to a sexual partner in more than 90% of 105 sample pairs. The direction couldn’t be established in the remaining cases, but the method didn’t incorrectly predict any transmissions.

Other research the CDC is pursuing may help estimate the recency of an infection, meaning whether one person acquired HIV more recently than another. Together, the data could enable additional predictions about when and how HIV infections occurred within transmission clusters. Benbow says the data on their own don’t prove direct transmission, since another individual could have been an intermediary in the chain, but Khanna points out that judges and juries wouldn’t necessarily take these scientific caveats into account. “We see a lot of potential for opening the door to criminalization,” she says.

Despite privacy assurances, Strub maintains that data collected for one purpose is being unethically used for another without patient consent. “It’s not being used evenly across the society. Molecular surveillance focuses on the communities that are already highly marginalized, communities where there is the greatest risk of serious, harmful consequences,” he says. “People of privilege don’t see this.”

In a 2019 letter in the journal Lancet, researchers at the University of California, San Diego responded to criticism of their molecular surveillance study of an HIV transmission cluster involving transgender women by questioning whether informed consent is “imperative” for such analyses. “Surveillance for numerous infectious agents, including HIV, is done ethically and without consent. The public good of HIV surveillance justifies this approach,” they wrote. “Requiring consent for surveillance reporting would preclude a robust understanding of disease distribution and spread and the ensuing benefit to the health of individuals and communities.”

Alexander McClelland, PhD, a postdoctoral researcher in the Department of Criminology at the University of Ottawa, says such arguments reflect the logic that people living with HIV are an “object of risk” to be managed by public health. “We’re not considered to be people who have autonomy or rights to privacy or security of our own lives and our own bodies and our own data,” he says.

Many defenses of molecular surveillance, McClelland adds, also overlook other implications beyond the “broader public good” of repurposing patient data for public health surveillance. Among them, he says, are the criminalization, uncertainty and fear of people who are living with HIV and subject to continual privacy breaches. “People love to say, ‘We’re looking at molecules not people.’ But those molecules are connected to people, and those people are in the social world,” McClelland says, “and you can’t evacuate a virus from the social context that it’s in.”

A Climate of Fear

According to the Center for HIV Law & Policy in New York City, 34 states have enacted some form of HIV criminalization law or sentencing enhancement for other crimes allegedly committed by a person living with HIV. Although the language varies, 21 states have laws under which HIV-positive people who are aware of their status but don’t disclose it to sexual partners can be prosecuted (additional states have prosecuted nondisclosure under different laws); 12 states require the same disclosure among people who share needles. Some laws cover alleged HIV exposure while others cover actual transmission. Between 2009 and 2019, 24 states also prosecuted people living with HIV under other criminal statutes.

The interpretations and enforcement of laws can vary widely as well. In an April 2020 report, the Williams Institute at the UCLA School of Law documented 209 arrests and 107 convictions under Missouri’s HIV criminalization laws between 1990 and 2009. The report noted that the crimes appeared to be disproportionately enforced in St. Louis and adjacent St. Louis County. Although Black men account for 5.5% of Missouri’s population and 35% of people living with HIV, the report found, they accounted for more than half of HIV crime arrests and convictions over the 20-year period.

“We’re oftentimes targeted by not just HIV laws but by a lot of other different laws. We’re more likely to experience surveillance by law enforcement,” Hursey says of Black men. Layering on the element of molecular surveillance, he adds, only compounds the fear and lack of trust in public health and discourages the honest answers and cooperation necessary for HIV peer educators like him to do their jobs effectively. That mistrust is heightened by the legal requirement that Missouri’s health department must turn over all surveillance data to prosecutors pursuing an HIV criminalization case, he says.

“We have an epidemic of criminalization of people living with HIV, and you can only be prosecuted or convicted if you know your HIV status,” Khanna says. If people already feel marginalized and stigmatized, she and Hursey say, the added threat of criminalization based on knowing their HIV status can deter them from ever seeking out testing or care—the very opposite of stated public health goals.

Marco Castro-Bojorquez, cochair of the HIV Racial Justice Now project, says molecular HIV surveillance could likewise put undocumented immigrants at risk, especially since their existence in the United States is already criminalized. “It’s problematic, and it breaks my heart because a lot of people that could be very affected are those that are so fearful of the government and don’t really know that it’s happening,” he says.

Across the border from Missouri, Mayer says public health data are “well protected” in Iowa. They weren’t always, but in 2014, Iowa reformed its HIV criminalization law. The updated statute, Mayer says, requires proof that an HIV-positive person was negligent in exposing a partner to the virus and prohibits molecular surveillance data gathered by the state health department from being used to prosecute anyone. “I had some upset prosecutors who have tried to come to me, with subpoenas, to get information, which we don’t allow,” he says. Prosecutors can gather the data from other sources, but the health department has largely cut its tether to law enforcement.

Even so, prosecutors have found other mechanisms to gather data and enforce Iowa’s HIV criminalization law. In May, a 33-year-old Black man was sentenced to 26 years for “knowingly” exposing three women and a minor to HIV and transmitting the virus to three of them.

Activists say public health agencies also cannot divorce their molecular surveillance plans, however well intentioned, from the current rollback of LGBTQ, immigrant and minority rights. Castro-Bojorquez says the Trump administration’s anti-immigrant rhetoric and policies have not only eroded the Latino community’s trust in public officials but also worsened health outcomes. “Those attacks,” he says, “and the promotion of hatred, rolling back the few rights that we had and we fought so hard for, they have an impact, and people die.”

Numerous undocumented immigrants held in crowded detention centers have contracted COVID-19, and some deported immigrants have brought the coronavirus back to Guatemala, Mexico and other countries. Fear of HIV criminalization or deportation, Castro-Bojorquez says, has led other immigrants to avoid or delay “official” activities, including HIV testing and treatment. “Late diagnosis is a major issue in our communities,” he says, adding that it’s a big contributor to higher mortality rates among Latino men.

***

Finding Common Ground

Amid the ongoing controversy, HIV activists and public health officials may be finding common ground on the need for more community engagement and on the importance of decoupling public health and law enforcement. In a 2019 commentary in the American Journal of Public Health, Benbow joined other AIDS researchers, bioethicists and a representative of the National Alliance of State and Territorial AIDS Directors (NASTAD) in explaining how multiple aspects of existing HIV criminalization laws could confound public health goals around molecular surveillance.

Benbow and her coauthors cautioned that using identified surveillance data against the interest of patients, especially without informing them, “could jeopardize community confidence in public health agencies.” The authors also noted the CDC’s requirement that funded health departments create plans to address gaps in data protection and consider eliminating or modifying potentially counterproductive laws. “In light of the considerations we have addressed, health department leaders should consider supporting statutes that expressly limit, or even prohibit entirely, release of surveillance data for law enforcement purposes,” they wrote.

Mokotoff cautions that a health department can’t always change its state law. “But the health department can work with the community to help them understand what needs to be done and what kind of wording might be helpful,” she says. “We have to stop allowing surveillance data to be used for prosecution of people who are sick or infected.” Protecting that data from being used in law enforcement, she adds, “would change the entire discussion” with stakeholders in the HIV-positive community.

The CDC itself has avoided criticizing specific state laws, though the agency source told POZ that the CDC has worked with partners like NASTAD to review the range of legal protections, policies and procedures that can help protect HIV data. The source noted that in 2014, the Department of Justice recommended that states either reform their laws to eliminate HIV-specific criminal penalties or modernize their laws to reflect current scientific evidence. The source also pointed out that the Department of Health and Human Services 2019 initiative, “Ending the HIV Epidemic: A Plan for America,” encourages states to take similar steps to help reduce stigma.

Benbow conceded that addressing the intense mistrust of underserved individuals who may need HIV prevention or treatment services the most, including people who inject drugs and undocumented immigrants, remains a steep challenge. But identifying clusters, she says, could help health officials make the case for targeted services that benefit underserved people, like the legalization of needle exchange programs.

“A lot of what we do in public health infringes on privacy, and what we’re trying to do is balance a person’s individual freedoms and liberties and privacy with trying to improve public health and work for the common good,” Mayer says. “You really have to think very carefully about that because if you push that too far, then you’re likely to get a lot of public health interventions rolled back, and people don’t want to work with you. They don’t trust you.” And as the history of HIV shows, regaining lost trust can take decades.

US: Interdisciplinary working group issues recommendations to better inform research while serving the interests of individuals affected by HIV

Addressing ethical challenges in US-based HIV phylogenetic research

Abstract

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials; in molecular epidemiology; and in public health surveillance programs.

Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in United States-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) community engagement; (4) legal issues; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

The full analysis can be downloaded here

Webinar: Molecular HIV Surveillance (PWN-USA, 2019)

PWN’s Barb Cardell’s webinar on Molecular HIV Surveillance and its implications for marginalized communities living with HIV, including intersections with HIV criminalization.

US: Anti-criminalisation advocates worried about use of molecular surveillance to identify transmission clusters

Will the Genetic Analysis–Based HIV Surveillance Safeguard Privacy?

The CDC is beginning to use molecular surveillance of HIV to identify transmission clusters, which has some privacy advocates concerned.

 

The future of the U.S. public health system’s efforts to track and respond to the spread of HIV is called molecular surveillance. The Centers for Disease Control and Prevention (CDC) has recently begun scaling up a program to analyze genetic sequencing of newly identified cases of the virus so as to identify transmission clusters: groups of people who share strains of HIV so genetically similar that the virus likely passed among them.

 Such a high-tech ability to characterize HIV’s pathway through sexual or injection-drug-use networks could open the door for local health departments to seek out individuals in such transmission webs or at risk of joining one so as to provide them tailored HIV care and treatment or prevention services.

 The epidemic-battling prospects of this dawning method of epidemic surveillance notwithstanding, an ad hoc group of HIV advocates has begun to raise concerns about what they see as the potential for the misuse of personal information gleaned from the process.

 Additionally, advocates point to the patchwork of laws that, depending on the state, make it a crime for people living with the virus not to disclose their HIV status, to potentially expose someone to the virus, or to transmit the virus to another individual during sex or the sharing of drug paraphernalia. At least in theory, a criminal case based on an alleged violation of such a law could prompt a subpoena for information from molecular surveillance records and ultimately allow such data to enter a court record.

 Molecular HIV surveillance, or MHS, “provides an opportunity to help address growing HIV disparities but only if it is implemented responsibly and in collaboration and partnership with communities affected by and living with HIV,” says Amy Killelea, JD, director of health systems integration at NASTAD (National Alliance of State & Territorial AIDS Directors). “Because MHS activities are rolling out in states with HIV criminal transmission statutes in place, it is important for health departments, providers and anyone charged with safeguarding this data to follow procedures for prohibiting or limiting its release.”

 How molecular HIV surveillance works

 When an individual tests positive for HIV and connects to medical care for the virus, his or her clinician typically orders drug resistance testing, sending a blood sample to a lab that genetically sequences the virus. The results are sent to the clinician and to the local health department. Then, depending on the state, the findings may be stripped of information connecting them to a named individual and sent from the health department to the CDC for further analysis. Looking at diagnoses from the previous three years, investigators at the federal agency will search for genetic matches among these de-identified cases of the virus—HIV strains that have no more than a 0.5 percent variation, or genetic distance, between them.

 The CDC is in especially hot pursuit of rapidly growing HIV transmission clusters, which the agency defines as a collection of genetically linked cases of which at least five were diagnosed within the most recent 12-month period. After identifying such a cluster, the CDC will report its findings to the health department that has jurisdiction over the majority of the related cases of the virus.

 That health department may then take action, for example, by engaging in a practice known as HIV partner services: contacting members of the transmission cluster and asking for their help in tracking down others in their sexual or drug-sharing network who may have been exposed to HIV in order to urge them to get tested for the virus.

 Among those individuals who test negative, health departments have an opportunity to promote HIV risk reduction, such as by prompting them to get on Truvada (tenofovir disoproxil fumarate/emtricitabine) as pre-exposure prophylaxis (PrEP).

 Those who test positive will ideally receive a prescription to antiretrovirals (ARVs) in short order. Immediate HIV treatment protects their health and, provided ARVs reduce their viral load to an undetectable level, renders them essentially unable to transmit the virus.

 Together, PrEP and HIV treatment use among those engaging in high-risk practices can help cut the links in transmission chains and possibly avert numerous downstream infections.

 On a wider scale, health departments can draw upon the findings from their investigations of transmission clusters to determine where they are coming up short in promoting HIV prevention and treatment services. They can also identify societal patterns that are facilitating HIV transmission—for example, if a lack of health care access among a particularly disenfranchised population is associated with an increased transmission rate among such individuals.

 At the February 2018 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, CDC epidemiologist Anne Marie France, PhD, MPH, presented a report on the agency’s recent efforts to identify molecular clusters, depicting this technology as a prime tool for helping to determine where and among whom the virus is rapidly transmitting. The agency, she said, was recently able to identify 60 rapid transmission clusters, which included five to 42 individuals, among whom the virus was transmitted at a rate 11 times greater than that of the general population.

The members of these clusters were disproportionately men who have sex with men, in particular young Latino MSM. Gathering such demographic information is especially vital as the CDC tries to make sense of why, in the MSM population, Latinos have seen a rising HIV transmission rate in recent years while the infection rate has leveled off among their Black counterparts and continued a long decline among white MSM.

 The effort to safeguard private information

 The late 1990s saw the beginning of a long-running debate about the potential costs of switching to a name-based system of reporting HIV test results, in which the names of people diagnosed with the virus were kept on file by state health departments. At the time, a broad swath of advocates expressed grave concerns that that this form of surveillance would lead to privacy violations and scare people away from testing for the virus.

 By and large, such fears were not borne out during the more than a decade it took for every state to switch over to name-based reporting. Instead, this recordkeeping transition proved vital in the CDC’s effort to comprehensively track the epidemic nationwide and to provide better-tailored responses.

 Now HIV advocates have staked a similarly critical stance with regard to molecular HIV surveillance: that the technology’s use may lead to privacy violations and also deter people who are concerned about such outcomes from getting tested.

 According to the CDC, the Public Health Service Act governs the privacy of information reported through the agency’s National HIV Surveillance System, forbidding its release for non-public-health purposes. This protection remains in effect in perpetuity, even after an individual’s death.

 In response to POZ’s inquiries about molecular HIV surveillance, a CDC spokesperson stated in an email: “As a condition of funding [from the federal agency], state and city health departments must comply with strict CDC standards for HIV data security, including multiple requirements for encryption of electronic data, physical security, limited access, [personnel] training and penalties if procedures aren’t followed.”

 For example, CDC policy holds that only authorized individuals should have access to information that identifies people included in molecular HIV surveillance analyses. Health agencies should print out such information only when necessary, and such hard copies should be kept under lock and key, not taken out of the health department office and shredded when they’re no longer in use.

 As for the matter of how such surveillance may affect individuals’ attitudes toward getting tested for HIV, the CDC relayed to POZ findings from a recent survey of young adults never tested for the virus. When asked their main reasons for not being screened, 70 percent reported they didn’t see themselves as at risk for HIV and 20 percent said they were never offered a test. The implication is that for most people, privacy concerns may not be a major factor affecting their willingness to get tested.

 Community engagement and response

 In the eyes of its critics, the CDC has not properly reached out to members of the HIV community for input about the scale-up of molecular surveillance.

 “I see how [molecular surveillance] could be beneficial for HIV prevention strategies in certain circumstances,” says Sean Strub, POZ’s founder and former publisher and the executive director of the Sero Project, a nonprofit that focuses on reforming HIV criminalization statutes. “But before [molecular surveillance is] utilized, the privacy and potential for abuse concerns need to be addressed in partnership with community activists.”

Addressing the CDC’s recent actions as it has pushed the rollout of molecular surveillance, David Evans, the interim executive director of Project Inform in San Francisco, says, “Meaningful engagement [by the CDC] with the communities most vulnerable to HIV has been sporadic and ineffective or completely absent in many geographic locations already. And I have yet to see concrete plans to ensure this takes place at the local, state and federal level going into the future.”

 Evans and Strub were among the attendees of a recent daylong meeting about molecular HIV surveillance convened by Georgetown Law School in Washington, DC. The confab, which included CDC representatives, heard concerns that partner services programs may wind up violating individuals’ privacy, including potentially sharing their sexual orientation, as outreach workers engage in partner services efforts.

 “Doing partner services successfully now takes a finesse that we have probably not developed in the staff across the country who are doing this work,” says another of the meeting’s attendees, Eve D. Mokotoff, MPH, director of HIV Counts in Ann Arbor, Michigan, which provides guidance on HIV surveillance issues nationally and internationally. “I am concerned that our country’s partner services workforce does not have the sensitivity, skill and tools needed to make them a welcome member of our prevention efforts. They too often offend clients, out them to others or otherwise are ineffective.”

 Mokotoff calls for improved education of such frontline public health staff in order to ensure the highest level of professionalism, discretion and sensitivity.

 As for the possibility that information acquired via molecular surveillance could be used in a criminal trial, Killelea notes the federal and state data privacy and security laws that limit health departments’ release of data except in narrow circumstances.

 “This is particularly important when it comes to the release of surveillance data for law enforcement purposes,” Killelea wrote in an email, “i.e., as a result of a court order or subpoena in the course of a prosecution under a state HIV criminal transmission statute.”

 “It’s important to note,” Killelea added, “that state laws vary on whether a subpoena or court order is required for health departments to release surveillance data and judges don’t necessarily need to approve a subpoena.”

 A likely safeguard, Killelea says, protecting molecular surveillance information from entering a trial is that for a judge to approve a subpoena such data would have to be able to prove the direction of HIV infection—who infected whom—which in most cases the technology cannot determine. Consequently, the release of this sort of information in a courtroom setting could be “rare or nonexistent,” according to Killelea. But as this surveillance technology advances, the directionality of infection could become provable, thus undermining such a legal safeguard.

 In response to such legal concerns, the CDC told POZ that the agency has “urged all state and local [health department] programs to review their own laws and policies for protection of data and to work with local policymakers to enhance protections as needed.”

 In an effort to guide such state-level policy revisions, the CDC has on hand a piece of model legislation called the Model State Public Health Privacy Act. And while the federal health agency is not actively engaging in an effort to change HIV criminalization statutes, a chief document on its website regarding molecular HIV surveillance suggests that states and local jurisdictions should “consider evaluating any laws that criminalize HIV transmission” as a part of a larger effort to “minimize the risk that molecular surveillance data will be misused or misinterpreted.”

Benjamin Ryan is POZ’s editor at large, responsible for HIV science reporting. His work has also appeared in The New York TimesNew YorkThe NationThe AtlanticThe Marshall ProjectThe Village Voice, QuartzOut and The AdvocateFollow him on Facebook and Twitter and at benryan.net.

Published in POZ on August 13, 2018

Bringing Science to Justice: End HIV Criminalisation Now

News Release

Networks of people living with HIV and human rights and legal organisations worldwide welcome the Expert Consensus Statement on the Science of HIV in the Context of Criminal Law

Amsterdam, July 25, 2018 — Today, 20 of the world’s leading HIV scientists released a ground-breaking Expert Consensus Statement providing their conclusive opinion on the low-to-no possibility of a person living with HIV transmitting the virus in various situations, including the per-act transmission likelihood, or lack thereof, for different sexual acts. This Statement was further endorsed by the International AIDS Society (IAS), the International Association of Providers of AIDS Care (IAPAC), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and 70 additional experts from 46 countries around the world.

The Expert Consensus Statement was written to both assist scientific experts considering individual criminal cases, and also to urge governments and criminal justice system actors to ensure that any application of the criminal law in cases related to HIV is informed by scientific evidence rather than stigma and fear. The Statement was published in the peer-reviewed Journal of the International AIDS Society (JIAS) and launched at a critical moment during the 22nd International AIDS Conference, now underway.

“As long-time activists who have been clamouring for a common, expert understanding of the current science around HIV, we are delighted with the content and widespread support for this Statement,” said Edwin J Bernard, Global Co-ordinator of the HIV Justice Network, secretariat to the HIV JUSTICE WORLDWIDE campaign. “Eminent, award-winning scientists from all regions of the world have come together to provide a clarion call for HIV justice, providing us with an important new advocacy tool for an HIV criminalisation-free world.”

The Statement provides the first globally-relevant expert opinion regarding individual HIV transmission dynamics (i.e., the ‘possibility’ of transmission), long-term impact of chronic HIV infection (i.e., the ‘harm’ of HIV), and the application of phylogenetic analysis (i.e., whether or not this can be used as definitive ‘proof’ of who infected whom). Based on a detailed analysis of scientific and medical research, it describes the possibility of HIV transmission related to a specific act during sexual activity, biting or spitting as ranging from low to no possibility. It also clearly states that HIV is a chronic, manageable health condition in the context of access to treatment, and that while phylogenetic results can exonerate a defendant when the results exclude them as the source of a complainant’s HIV infection, they cannot conclusively prove that one person infected another.

“Around the world, we are seeing prosecutions against people living with HIV who had no intent to cause harm. Many did not transmit HIV and indeed posed no actual risk of transmission,” said Cécile Kazatchkine, Senior Policy Analyst with the Canadian HIV/AIDS Legal Network, a member and key partner organisation of the HIV JUSTICE WORLDWIDE campaign. “These prosecutions are unjust, and today’s Expert Consensus Statement confirms that the law is going much too far.”

Countless people living with HIV around the world are currently languishing in prisons having been found guilty of HIV-related ‘crimes’ that, according the Expert Consensus Statement, do not align with current science. One of those is Sero Project Board Member, Kerry Thomas from Idaho, who says: “I practiced all the things I knew to be essential to protect my sexual partner: working closely with my doctor, having an undetectable viral load, and using condoms.  But in terms of the law, all that mattered was whether or not I disclosed. I am now serving a 30-year sentence.”

FINAL_KERRY_NOT-A-CRIME-POSTERWhile today’s Statement is extremely important, it is also crucial to recognise that we cannot end HIV criminalisation through science alone. Due to the numerous human rights and public health concerns associated with HIV criminalisation, UNAIDS, the Global Commission on HIV and the Law, the UN Committee on the Elimination of Discrimination against Women, and the UN Special Rapporteur on the Right to Health, among others, have all urged governments worldwide to limit the use of the criminal law to cases of intentional HIV transmission. (These are extremely rare cases wherein a person knows their HIV-positive status, acts with the intention to transmit HIV, and does in fact transmit the virus.)

We must also never lose sight of the intersectional ways that — due to factors such as race, gender, economic or legal residency status, among others — access to HIV treatment and/or viral load testing, and ability to negotiate condom use are more limited for some people than others. These are also the same people who are less likely to encounter fair treatment in court, within the medical system, or in the media.

“Instead of protecting women, HIV criminalisation places women living with HIV at increased risk of violence, abuse and prosecution,” says Michaela Clayton, Executive Director of the AIDS and Rights Alliance for Southern Africa (ARASA). “The scientific community has spoken, and now the criminal justice system, law and policymakers must also consider the impact of prosecutions on the human rights of people living with HIV, including women living with HIV, to prevent miscarriages of justice and positively impact the HIV response.”

HIV criminalisation is a pervasive illustration of systemic discrimination against people living with HIV who continue to be stigmatised and discriminated against on the basis of their status. We applaud this Statement and hope it will help end HIV criminalisation by challenging all-too-common mis-conceptions about the consequences of living with the virus, and how it is and is not transmitted. It is indeed time to bring science to HIV justice.

To read the full Expert Consensus Statement, which is also available in French, Spanish and Russian in the Supplementary Materials, please visit the Journal of the International AIDS Society at https://onlinelibrary.wiley.com/doi/full/10.1002/jia2.25161

VIsit the HIV JUSTICE WORLDWIDE website to read a short summary of the Expert Consensus statement here: http://www.hivjusticeworldwide.org/en/expert-statement/

To understand more about the context of the Expert Consensus Statement go to: http://www.hivjusticeworldwide.org/en/expert-statement-faq/

HIV JUSTICE WORLDWIDE is a growing, global movement to shape the discourse on HIV criminalisation as well as share information and resources, network, build capacity, mobilise advocacy, and cultivate a community of transparency and collaboration. It is run by a Steering Committee of ten partners AIDS Action Europe, AIDS-Free World, AIDS and Rights Alliance for Southern Africa (ARASA), Canadian HIV/AIDS Legal Network, Global Network of People Living with HIV (GNP+), HIV Justice Network, International Community of Women Living with HIV (ICW), Southern Africa Litigation Centre (SALC), Sero Project, and Positive Women’s Network – USA (PWN-USA) and currently comprises more than 80 member organisations internationally.

US: Webinar on HIV criminalisation primarily aimed at defense lawyers organised by NACDL and CHLP on Dec 15

On December 7, 2017, the National Association of Criminal Defense Lawyers (NACDL) and The Center for HIV Law & Policy (CHLP), will co-host a webinar on HIV Criminalization that will provide participants with a medical primer about the current state of medicine with regard to HIV research and treatment. This primer, geared toward criminal defense attorneys, but open to all, will be coupled with a discussion on how to use medical research to develop defenses, present the court with mitigation, negotiate favorable pleas for clients, and litigate constitutional, evidentiary, and discovery issues. There will also be a section exploring the ethical issues that attorneys must grapple with when handling these cases.

Date:   Thursday, December 7, 2017

When:  1:30 p.m. – 3:00 p.m. ET

Cost:   FREE

CLE credit:  Available for up to *1.5 hours of CLE (general) where self-study credit authorized and approved.

Register:  Click here to register.

Note:   Confirmed registrants will receive a web link via email the morning of the event.

Registrants will be sent a link to the written CLE materials in advance of the webinar.

Presenters

Dr. David Wohl (Chapel Hill, NC)

David Alain Wohl, MD is a Professor of Medicine in the Division of Infectious Diseases at the University of North Carolina (UNC). He is Site Leader of the UNC AIDS Clinical Trials Unit at Chapel Hill, Director of the North Carolina AIDS Education and Training Center (AETC) and Co-Directs HIV Services for the North Carolina state prison system. In 2014, he became Co-Director of the UNC-Duke-Clinical RM Ebola Response Consortium. Dr. Wohl’s research aims to optimize the treatment of HIV including the identification of the most effective therapeutic approaches, and minimizing adverse effects of therapy. He also is active in investigations focused on HIV vulnerable populations, such as the incarcerated. He is active within the US AIDS Clinical Trials Group and HIV Prevention Trials Network and served two terms as a member of the US Department of Health and Human Services Antiretroviral Guidelines Panel. As part of the response to the 2013-16 Ebola outbreak in West Africa, Dr. Wohl led UNC clinical research efforts to test interventions for Ebola Virus Disease in Liberia and now directs a clinical cohort of Ebola survivors. In addition to his research and administrative activities, Dr. Wohl maintains a large HIV continuity clinic at UNC.

Stephen Scarborough  (Atlanta, GA)

Stephen R. (Steve) Scarborough is a criminal defense attorney in Atlanta whose practice focuses on appellate and post-conviction matters in state and federal courts. A graduate of Emory University and Yale Law School, he has been a longtime public defender, a staff attorney at the Southern Regional Office of Lambda Legal, and an attorney in private practice representing persons accused in serious felony cases. He is interested in the intersection of the criminal law and public health and has represented several persons who were accused of HIV-related offenses or were subject to enhanced sentences on account of their status. He is part of a community effort to replace Georgia’s outdated, HIV-specific reckless conduct statute, which imposes felony liability in a broad range of cases where transmission of HIV is nearly or totally impossible.

UK: Whole genome sequencing shows potential as public health tool, but not yet able to definitively prove direction (or timing) in criminal cases

Potential for phylogenetic analysis to show direction of HIV transmission

Tentative results presented in a poster at BHIVA 2017 suggest that a new approach to phylogenetic testing might have the potential to show the direction of HIV infection between two individuals.

While the results are exciting from a scientific perspective, if the approach proves to be robust, this will raise many ethical and legal questions.

Until now, phylogenetic analysis, where sections of two viruses are compared for similarity, has been able to show similarity but crucially not direct infection (a third person could be involved) or direction of infection. Phylogenetic analysis is most useful for showing when transmissions are definitely not linked, when the two strains are unrelated. When linkage is shown, direction of infection cannot be inferred nor the possibility that both infections originated from intermediary partners.

The current study, presented as a poster by Kate El Bouzidi and colleagues from Brighton and Sussex University Hospitals Trust, used whole genome sequencing (WGS) to look at genetic diversity at each of the >9000 individual nucleotide sites in two linked viruses, with heterogeneous samples being interpreted as being the source virus for the sample which had homogeneity at the same nucleotide site.

WGS performed on 170 samples from a UK MSM cohort identified five linked pairs and these were compared to four control pairs where linkage was already established and direction inferred from clinical notes.

The direction of travel was able to be inferred using WGS for 3/4 control pairs, with the single indeterminate result linked to a sample that was taken so long after transmission took place that natural divergence was too great to determine direction.

WGS-inferred direction was consistent with clinical data for 2/5 case pairs. The lack of a signal in two further case pairs with indeterminate was able to be interpreted as not supportive direct transmission, but missing intermediary partners from whom samples were not available.

Finally, the case where WGS-inferred transmission did not match clinical route, was when the sample from the source partner was taken during primary infection (when HIV is likely to be homogenous at most points) several years before likely transmission to the second partner (whose sample was only taken during chronic infection (when heterogeneity is more likely).

This study is funded by both BHIVA and Public Health England as part of the COMPARE-HIV Study (Comparison of Molecular & Phylogenetic Approaches to Reconstruct an Epidemic of HIV), based at Brighton and Sussex University Hospitals NHS Trust.

Comment

The results are preliminary and clearly the timing of samples is likely to be important when interpreting the results from this approach.

WGS may improve our understanding of transmission networks at a population level but it cannot be used to confirm direct transmission at an individual level and sequence data should always be interpreted cautiously in conjunction with clinical information.

However, if the methodology is supported in larger analyses, the results will raise important ethical and legal concerns, especially in countries where HIV transmission is still criminalised.

Reference:

El Bouzidi K et al. Insights into the dynamics of HIV-1 transmission using whole genome deep sequencing. 23rd BHIVA, 4-7 April 2017, Liverpool. Poster abstract P31.

US: Mark S. King explores why the breakthrough message equating "HIV undetectable to untransmittable" matters

Five Reasons ‘HIV Undetectable’ Must Equal ‘Untransmittable’

December 15, 2016

We are not dirty, we are not a threat, and we are not disease vectors. In fact, we are the solution. People living with HIV who achieve viral suppression, who become undetectable, are the solution to the end of new HIV infections in the United States. … When we look back 20 years from now we’re going to judge ourselves in terms of how well we responded to this opportunity.

Dr. Rich Wolitski, person living with HIV and acting director for the Office for HIV/AIDS and Infectious Disease Policy at the U.S. Department of Health and Human Services

When Dr. Wolitski delivered his speech at the closing plenary of the 2016 United States Conference on AIDS (USCA), he received a standing ovation. He was referring to this year’s newest findings of HPTN 052 and the PARTNER study, which showed that people living with HIV who are undetectable are not transmitting the virus to their negative partners.

How wonderful that something many of us have assumed for years has been proven to be true. So now we can spread the news and encourage people with HIV to seek treatment and stick with it. And hey, there’s nothing like a little intercourse a la natural with your partner to reward yourself for being undetectable, am I right?

Not so fast. There is some strong resistance to a message that equates undetectable to untransmittable, and it’s not coming from where you might think.

Here are five reasons why this breakthrough message matters.

1. The science is solid.

The PARTNER Study has recorded 58,000 acts of penetrative sex without condoms between 1,000 positive/negative couples, in which the HIV positive partner had an undetectable viral load. There were no infections between the couples. Not a single one. The same results were reported in the HPTN 052 study and the empirical evidence to date. As Dr. Wolitiski said in his USCA speech, “this is a game-changing moment in the history of the HIV epidemic.”

Resistance to the conclusion that undetectable people pose no risk of infection has been either a matter of scientific data scrutiny or a fear that people may not actually be undetectable when they think they are. Let’s break that down.

A review of the argument against saying “zero risk” is enough to make you cross-eyed. It is based on the premise that nothing, really, is without risk. Detractors of the non-infectious message will calmly explain the perils of placing any risk at zero and then hypnotize you with statistical origami. Suffice it to say that proving zero risk is statistically impossible. You risked electrocution by turning on your device to read this article.

There will always be somebody who claims a terminally unique HIV infection, even if the precise circumstances of their claim may be murky. Weird things happen. Some folks are convinced that people who drink alcohol sometimes spontaneously combust. But you don’t see warning labels about it slapped on every bottle of Wild Turkey by overzealous worrywarts.

And yes, there is the possibility that someone might develop a viral load if they are not adherent to treatment and then transmit the virus. But the message here is that people who are undetectable cannot transmit HIV. If you stay on treatment and are undetectable you will not transmit HIV. Can we please celebrate this simple fact without remote qualifiers?

It is also important to note that a Canadian consensus statement concluded that any “viral blips” or sexually transmitted infections (STIs) were “not significant” to HIV transmission when someone is undetectable.

2. Major health experts are on board (but not all community leaders).

Public health leaders, from the New York Department of Health to the National Institutes of Health (NIH), have embraced these findings and its meaning to people with HIV, while community advocates and organizations have been reluctant to get on board, citing a theoretical risk of infection. Or maybe they consider changing their fact sheets and web sites an enormous bother.

The Prevention Action Campaign and their seminal message “U=U” (undetectable equals untransmittable) was founded on the energetic efforts of a man named Bruce Richman. He entered the HIV advocacy scene a few years ago, seemingly out of nowhere, carrying aloft the banner of undetectability. Richman gathered signatures of health experts the world over for a consensus statement about the research, while cajoling every U.S. HIV organization in sight to adopt language that removes the stigma of infectiousness from people who are undetectable.

My review of the web sites and statements from major HIV organizations includes no strong language about undetectable people not transmitting HIV. Worse, some exaggerate the risk from those who are undetectable. How could such a new research breakthrough be met with such ignorance and apathy by our own leaders? I will defer shaming anyone by name while they take a little time to update their official language. (Notable exceptions to this sad rule include work going on in the United Kingdom and France that flatly states that undetectable means non-infectious.)

This skepticism from our own community reduces people with HIV, again, to a problem that must be managed. It suggests that those of us who have achieved undetectability don’t have the judgment to keep taking our medications or to see our physician regularly to be sure our treatment plan is still effective. It keeps us in the role of untrustworthy victims unable to make decisions that will keep the rest of you safe from us. What infuriating, stigmatizing nonsense.

3. This is about HIV. Only HIV.

Auxiliary issues often creep into this debate that may be well-meaning but only muddy the waters, such as the fear that promoting the message of non-infectiousness will lead to more sexually transmitted infections (STIs) because of the freedom it allows (see also: critics of PrEP, the birth control pill, and any other vehicle that might lead to unbridled sexual pleasure).

Rates of STIs — which were on the rise before the advent of PrEP or news from the PARTNER Study — are deeply concerning but ultimately tangential. We are in desperate need of comprehensive sexual health programs, to be sure, but in this instance I feel compelled to “kill the alligator closest to the boat.” This is about being HIV undetectable, not syphilis impermeable. Being undetectable will not prevent other infections or address promiscuity or remove stubborn stains.

Advocates are also sensitive to the continued compartmentalization of our community, between those who are positive or not, who is on PrEP or not, and now, between those with HIV who are able to achieve viral suppression and those who cannot, despite their best efforts. I sympathize with this new divide among HIV positive people but believe the greater good — removing shame and stigma from those who are not capable of transmitting — shouldn’t be downplayed. All HIV positive people of good will can and should celebrate this development, regardless of their own viral load.

4. This is a major victory for HIV criminalization reform.

Terribly important work is being done to repeal and reform HIV criminalization laws that prosecute people with HIV for not disclosing their status to a sexual partner. Our lead defense is often that the defendant never posed a risk to their partner in the first place, due to their use of protection or the fact the defendant was undetectable and therefore rendered harmless.

Imagine the glee with which prosecutors might punch holes in this defense, based on statistical mumbo-jumbo saying “zero risk” is impossible and using it to explain to a jury that Joe Positive did, in fact, pose a risk to his sexual partner and should be jailed for it. Put that doubt into the heads of a jury, and another person with HIV gets a 30-year sentence for daring to have sex at all.

5. This profoundly changes how people with HIV view themselves.

Internalizing the fact that I cannot transmit HIV to anyone has had an effect on me that is difficult to describe. I can only liken it to the day the Supreme Court voted for marriage equality. Intellectually, I knew I was a gay man and a worthy human being. But on the day of the court’s decision I walked through the streets of my neighborhood with my head held higher. Something had changed. I felt whole.

In my thirty-five years living with HIV, I have never felt exactly that way. I deserve to. And so do millions of other people with HIV.

Of all the arguments to adopt the message that undetectable people cannot transmit HIV, that enhanced feeling of self-worth may be the most important reason of them all.

 

Australia: Analysis of the limitations of scientific evidence to prove timing and direction of alleged HIV transmission in three criminal trials

This article by Paul Kidd in the March 2016 issue of HIV Australia examines the use of HIV phylogenetic analysis in three Australian criminal trials. It argues that courts in Australia appear to accept forensic evidence uncritically. As the forensic methodology used in phylogenetic analysis is inherently limited, it argues there is risk of miscarriage of justice where this type of evidence forms a substantial part of the prosecution case.

Read the full article at: https://www.afao.org.au/library/hiv-australia/volume-14/vol-14-no-1/phylogenetic-analysis-as-expert-evidence-in-hiv-transmission-prosecutions