Going off antiretroviral treatment in a closely monitored HIV “cure” trial: longitudinal assessments of acutely diagnosed trial participants and decliners

Henderson, Gail E.; Waltz, Margaret; Meagher, Karen M.; Cadigan, R. Jean; Jupimai, Thidarat; Isaacson, Sinéad; Ormsby, Nuchanart; Colby, Donn; Kroon, Eugène; Phanuphak, Nittaya; Ananworanich, Jintanat; Peay, Holly

doi:10.1002/jia2.25260

Cited by 25 publications

(51 citation statements)

References 21 publications

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“…The ongoing RV254/SEARCH010 cohort in Bangkok has proven to be fertile ground for the development and implementation of HIV remission trials, leveraging evidence that the lower reservoir size and preserved immune function of individuals who start ART during acute infection might facilitate viral control in the absence of ART. The study has shown that execution of observational and interventional research during the period surrounding acute HIV infection is safe, feasible, and acceptable to participant populations [55, 56]. This includes research that involves invasive procedures such as lumbar puncture and lymph node biopsy [57, 58].…”

Section: Introductionmentioning

confidence: 99%

Leveraging early HIV diagnosis and treatment in Thailand to conduct HIV cure research

et al. 2019

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Thailand has the highest prevalence of HIV among countries in Asia but has also been a pioneer in HIV prevention and treatment efforts in the region, reducing the incidence of new infections significantly over the last two decades. Building upon this remarkable history, Thailand has set an ambitious goal to stop the AIDS epidemic in the country by 2030. A key component of the strategy to achieve this goal includes scale-up of HIV screening programs to facilitate early HIV diagnosis and investment in mechanisms to support immediate initiation of antiretroviral therapy (ART). Initiation of ART during early or acute HIV infection not only reduces viremia, thereby halting onward transmission of HIV, but also may facilitate HIV remission by reducing the size of the latent HIV reservoir and preserving immune function. In Thailand, many efforts have been made to reduce the time from HIV infection to diagnosis and from diagnosis to treatment, especially among men who have sex with men and transgender women. Successfully identifying and initiating ART in individuals with acute HIV infection has been leveraged to conduct groundbreaking studies of novel strategies to achieve HIV remission, including studies of broadly-neutralizing HIV-specific monoclonal antibodies and candidate therapeutic vaccines. These efforts have mostly been deployed in Bangkok and future efforts should include other urban and more rural areas. Continued progress in HIV prevention, screening, and treatment will position Thailand to substantially limit new infections and may pave the way for an HIV cure.

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Section: Introductionmentioning

confidence: 99%

Leveraging early HIV diagnosis and treatment in Thailand to conduct HIV cure research

et al. 2019

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“…Supportive BSSR also includes understanding how participants make decisions to participate in HIV cure research. With the support of biomedical HIV cure research teams, socio‐behavioural scientists are increasingly able to understand decision‐making processes of those who decide to participate (or not) in HIV cure research, rather than relying on hypothetical intentions and perceptions . Supportive BSSR may also include patient‐reported outcomes (PROs) and patient‐reported experience measures (PREMs) completed by participants to assess the effects of study participation on various critical domains, such as well‐being, symptoms, functioning, adverse events and experiences with interventions, studies and ATIs .…”

Section: Discussionmentioning

confidence: 99%

“…BSSR methods can help the field come to consensus around critical parameters and safeguards to maximize ATIs' utility while minimizing risks . Supportive BSSR can also help in understanding various aspects of informed consent related to HIV cure research, including how participants understand the risks and benefits of research . BSSR can provide strategies to measure adherence or non‐adherence to ART and ATIs .…”

Section: Discussionmentioning

confidence: 99%

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

et al. 2019

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Introduction The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt’s BSSR Functional Framework to the field of HIV cure research. Discussion The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi‐disciplinary combination approaches for real‐world implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of “cure” to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants related to different cure strategies; HIV care providers’ perceptions and attitudes about their patients’ participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio‐behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi‐disciplinary approach at all stages of cure research to ensure the real‐world applicability of any strategy that shows promise.

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“…Overall, she finds that both groups scored highly on a measure incorporating self-assessed informational clarity, support in decision-making and satisfaction with a choice. She also found that all eight of those who did participate in the research were initially motivated in part by the prospect of stopping ART, all eight reported elements of the treatment interruption as positive and all eight remained satisfied with their initial choice 9 13 …”

Section: Short Well-monitored Treatment Interruptionsmentioning

confidence: 97%

Reconceptualising risk–benefit analyses: the case of HIV cure research

Steel

2019

J Med Ethics

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Modern antiretroviral therapies (ART) are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer ‘no’. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant.

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Going off antiretroviral treatment in a closely monitored HIV “cure” trial: longitudinal assessments of acutely diagnosed trial participants and decliners

Cited by 25 publications

References 21 publications

Leveraging early HIV diagnosis and treatment in Thailand to conduct HIV cure research

Leveraging early HIV diagnosis and treatment in Thailand to conduct HIV cure research

Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research

Reconceptualising risk–benefit analyses: the case of HIV cure research

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