Toward Consent in Molecular HIV Surveillance?: Perspectives of Critical Stakeholders.

BACKGROUND: The emergence of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs as key features of the United States (US) HIV strategy since 2018 has caused major controversies. HIV surveillance programs that re-use individuals' routinely collected clinical HIV data do not require consent on the basis that the public benefit of these programs outweighs individuals' rights to opt out. However, criticisms of MHS/CDR have questioned whether expanded uses of HIV genetic sequence data for prevention reach beyond traditional public health ethics frameworks. This study aimed to explore views on consent within MHS/CDR among critical stakeholders. METHODS: In 2021 we interviewed 26 US HIV stakeholders who identified as being critical or concerned about the rollout of MHS/CDR. Stakeholders included participants belonging to networks of people living with HIV, other advocates, academics, and public health professionals. This analysis focused on identifying the range of positions among critical and concerned stakeholders on consent affordances, opt-outs, how to best inform people living with HIV about how data about them are used in public health programs, and related ethical issues. RESULTS: Participants were broadly supportive of introducing some forms of consent into MHS/CDR. However, they differed on the specifics of implementing consent. While some participants did not support introducing consent affordances, all supported the idea that people living with HIV should be informed about how HIV surveillance and prevention is conducted and how individuals' data are used. CONCLUSIONS: MHS/CDR has caused sustained controversy. Among critical stakeholders, consent is generally desirable but contested, although the right for people living with HIV to be informed was centrally supported. In an era of big data-driven public health interventions and routine uses of HIV genetic sequence data in surveillance and prevention, CDC and other agencies should revisit public health ethics frameworks and consider the possibility of consent processes.

Health policy counterpublics: Enacting collective resistances to US molecular HIV surveillance and cluster detection and response programs.

Health policies and the problems they constitute are deeply shaped by multiple publics. In this article we conceptualize health policy counterpublics: temporally bounded socio-political forms that aim to cultivate particular modes of conduct, generally to resist trajectories set by arms of the state. These counterpublics often emerge from existing social movements and involve varied forms of activism and advocacy. We examine a health policy counterpublic that has arisen in response to new forms of HIV public health surveillance by drawing on public documents and interview data from 2021 with 26 stakeholders who were critical of key policy developments. Since 2018, the national rollout of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs in the United States has produced sustained controversies among HIV stakeholders, including among organized networks of people living with HIV. This article focuses on how a health policy counterpublic formed around MHS/CDR and how constituents problematized the policy agenda set in motion by federal health agencies, including in relation to data ethics, the meaningful involvement of affected communities, informed consent, the digitization of health systems, and HIV criminalization. Although familiar problems in HIV policymaking, concerns about these issues have been reconfigured in response to the new sociotechnical milieu proffered by MHS/CDR, generating new critical positions aiming to remake public health. Critical attention to the scenes within which health policy controversies play out ought to consider how (counter)publics are made, how problems are constituted, and the broader social movement dynamics and activist resources drawn upon to contest and reimagine policymaking in public life.

Exploring team dynamics during the development of a multi-institutional cross-disciplinary translational team: Implications for potential best practices.

Introduction: A recent literature review revealed no studies that explored teams that used an explicit theoretical framework for multiteam systems in academic settings, such as the increasingly important multi-institutional cross-disciplinary translational team (MCTT) form. We conducted an exploratory 30-interview grounded theory study over two rounds to analyze participants' experiences from three universities who assembled an MCTT in order to pursue a complex grant proposal related to research on post-acute sequelae of COVID-19, also called "long COVID." This article considers activities beginning with preliminary discussions among principal investigators through grant writing and submission, and completion of reviews by the National Center for Advancing Translational Sciences, which resulted in the proposal not being scored. Methods: There were two stages to this interview study with MCTT members: pre-submission, and post-decision. Round one focused on the process of developing structures to collaborate on proposal writing and assembly, whereas round two focused on evaluation of the complete process. A total of 15 participants agreed to be interviewed in each round. Findings: The first round of interviews was conducted prior to submission and explored issues during proposal writing, including (1) importance of the topic; (2) meaning and perception of "team" within the MCTT context; and (3) leadership at different levels of the team. The second round explored best practices-related issues including (1) leadership and design; (2) specific proposal assembly tasks; (3) communication; and (4) critical events. Conclusion: We conclude with suggestions for developing best practices for assembling MCTTs involving multi-institutional teams.

Botswana tuberculosis (TB) stakeholders broadly support scaling up next-generation whole genome sequencing: Ethical and practical considerations for Botswana and global health.

Global health agencies are increasingly promoting the scale-up of next-generation whole genome sequencing (NG-WGS) of pathogens into infectious disease control programs, including for tuberculosis (TB). However, little is known about how stakeholders in low-to-middle income countries (LMICs) understand the ethics, benefits, and risks of these proposals. We conducted a qualitative study in Greater Gaborone, Botswana to learn how TB stakeholders there viewed a potential scale-up of NG-WGS into Botswana's TB program. We conducted 30 interviews and four deliberative dialogues with TB stakeholders based in Greater Gaborone, the country's largest city and capital. We created and showed participants an animated video series about a fictional family that experienced TB diagnosis, treatment, contact tracing, and data uses that were informed by NG-WGS. We analyzed transcripts using reflexive thematic analysis. We found broad support for the scale-up of TB NG-WGS in Botswana, owing to perceived benefits. Support was qualified with statements about ensuring adequate planning, resource-allocation, community and stakeholder engagement, capacity-building, and assessing ethical norms around publishing data. Our results suggest that scaling up NG-WGS for TB in Botswana would be supported by stakeholders there, contingent upon the government and other entities adequately investing in the initiative. These findings are relevant to other LMICs considering scale-ups of NG-WGS and related technologies for infectious diseases and suggest the need for sustained research into the acceptability of pathogen sequencing in other contexts.

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

Policy Points Molecular HIV surveillance and cluster detection and response (MHS/CDR) programs have been a core public health activity in the United States since 2018 and are the "fourth pillar" of the Ending the HIV Epidemic initiative launched in 2019. MHS/CDR has caused controversy, including calls for a moratorium from networks of people living with HIV. In October 2022, the Presidential Advisory Council on HIV/AIDS (PACHA) adopted a resolution calling for major reforms. We analyze the policy landscape and present four proposals to federal stakeholders pertaining to PACHA's recommendations about incorporating opt-outs and plain-language notifications into MHS/CDR programs.

Long COVID and mental health correlates: a new chronic condition fits existing patterns.

Background: Emerging Long COVID research indicates the condition has major population health consequence. Other chronic conditions have previously been associated with functional and mental health challenges - including depression, anxiety, post-traumatic stress disorder (PTSD), suicide ideation, substance use and lower life satisfaction. Methods: This study explores correlations between self-reported Long COVID, functional and mental health challenges among a random community-based sample of people (n = 655) aged 20-50 years who contracted COVID-19 prior to vaccination in a Texas county. A random sample of eligible participants was mailed a link to participate in a semi-structured questionnaire. Participant responses, including open-ended responses regarding their experience following COVID-19, were paired with health system data. Results: Long COVID was associated with increased presence of depression (13% increase), anxiety (28% increase), suicide ideation (10% increase), PTSD (20% increase), and decreased life satisfaction and daily functioning. Structural equation modeling, controlling for sociodemographic variables and imposing a theoretical framework from existing chronic disease research, demonstrated correlations between Long COVID and higher PTSD, suicide ideation and lower life satisfaction were mediated by higher daily functional challenges and common mental disorders. Conclusions: Basic and applied, interdisciplinary research is urgently needed to characterize the population-based response to the new challenge of Long COVID.

Open science, COVID-19, and the news: Exploring controversies in the circulation of early SARS-CoV-2 genomic epidemiology research.

Some early English language news coverage of COVID-19 epidemiology focused on studies that examined how SARS-CoV-2 (the coronavirus that causes COVID-19) was evolving at the genetic level. The use of phylogenetic methods to analyse pathogen genetic sequence data to understand disease dynamics is called 'molecular' or 'genomic' epidemiology. Many research groups in this subfield utilise open science practices, which can involve the circulation of early unreviewed findings on publicly-accessible venues online. From March to May 2020, media outlets covered early SARS-CoV-2 genomic studies that claimed to have discovered types of SARS-CoV-2 that had mutated to be more transmissible. We use methods from Science and Technology Studies (STS) to examine three cumulative cases in which unripe facts about SARS-CoV-2 genomics moved out of scientific publics and into mainstream news. The three cases are: (1) 'A More "Aggressive" Strain of SARS-CoV-2?', (2) 'Eight SARS-CoV-2 Strains?', and (3) 'A "More Contagious," "Mutant" Strain?' In each case, findings were called into question and reporters' framing was overly sensational. We interpret the COVID-19 pandemic as a 'stress-test' for open science practices, and argue that it is important for stakeholders to understand changes in scientific publication and dissemination processes in the wake of the pandemic.

Alternatives to sharing COVID-19 data with law enforcement: Recommendations for stakeholders.

During the COVID-19 pandemic, in some jurisdictions, police have become involved in enforcing coronavirus-related measures. Relatedly, several North American jurisdictions have established COVID-19 data sharing protocols with law enforcement. Research across a range of fields has demonstrated that involving police in matters of public health disproportionately impacts the most vulnerable and does more harm than good. This is reflected in the consensus against COVID-19 criminalization that has emerged among civil society organizations focused on HIV, human rights, and harm reduction. The European Data Protection Board has also released guidelines against re-uses of COVID-19 data for law enforcement purposes. This article offers an overview of the harms of criminalizing illnesses and strategies for health stakeholders to seek alternatives to sharing COVID-19 data with police agencies while facilitating interoperability with healthcare first responders. It also presents case studies from two North American jurisdictions - Ontario and Minnesota - that have established routine COVID-19 data sharing with police. We recommended seven alternatives, including designating COVID-19 data as sensitive and implementing segmented interoperability with first responder agencies. These guidelines can help ensure that health information technology platforms do not become vehicles for the criminalization of COVID-19, and that health data stay within the health system.

A scoping review of qualitative research in JAMIA: past contributions and opportunities for future work.

OBJECTIVE: Qualitative methods are particularly well-suited to studying the complexities and contingencies that emerge in the development, preparation, and implementation of technological interventions in real-world clinical practice, and much remains to be done to use these methods to their full advantage. We aimed to analyze how qualitative methods have been used in health informatics research, focusing on objectives, populations studied, data collection, analysis methods, and fields of analytical origin. METHODS: We conducted a scoping review of original, qualitative empirical research in JAMIA from its inception in 1994 to 2019. We queried PubMed to identify relevant articles, ultimately including and extracting data from 158 articles. RESULTS: The proportion of qualitative studies increased over time, constituting 4.2% of articles published in JAMIA overall. Studies overwhelmingly used interviews, observations, grounded theory, and thematic analysis. These articles used qualitative methods to analyze health informatics systems before, after, and separate from deployment. Providers have typically been the main focus of studies, but there has been an upward trend of articles focusing on healthcare consumers. DISCUSSION: While there has been a rich tradition of qualitative inquiry in JAMIA, its scope has been limited when compared with the range of qualitative methods used in other technology-oriented fields, such as human-computer interaction, computer-supported cooperative work, and science and technology studies. CONCLUSION: We recommend increased public funding for and adoption of a broader variety of qualitative methods by scholars, practitioners, and policy makers and an expansion of the variety of participants studied. This should lead to systems that are more responsive to practical needs, improving usability, safety, and outcomes.

Reassessing the Ethics of Molecular HIV Surveillance in the Era of Cluster Detection and Response: Toward HIV Data Justice.

In the United States, clinical HIV data reported to surveillance systems operated by jurisdictional departments of public health are re-used for epidemiology and prevention. In 2018, all jurisdictions began using HIV genetic sequence data from clinical drug resistance tests to identify people living with HIV in "clusters" of others with genetically similar strains. This is called "molecular HIV surveillance" (MHS). In 2019, "cluster detection and response" (CDR) programs that re-use MHS data became the "fourth pillar" of the national HIV strategy. Public health re-uses of HIV data are done without consent and are a source of concern among stakeholders. This article presents three cases that illuminate bioethical challenges associated with re-uses of clinical HIV data for public health. We focus on evidence-base, risk-benefit ratio, determining directionality of HIV transmission, consent, and ethical re-use. The conclusion offers strategies for "HIV data justice." The essay contributes to a "bioethics of the oppressed."