Abstract
HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval.
Highlights
While exact definitions vary [1], acute HIV infection (AHI) generally refers to the brief period between initial infection and detectable HIV-specific antibodies, i.e., seroconversion [1,2,3]
This study found AHI people to have a substantial burden of psychiatric morbidities, including alcohol/ substance abuse disorders
We suggest three primary domains of potential ethical concern for HIV remission clinical studies involving AHI participants
Summary
While exact definitions vary [1], acute HIV infection (AHI) generally refers to the brief period (circa 25 days; designated Fiebig stages 1 and 2) between initial infection and detectable HIV-specific antibodies, i.e., seroconversion [1,2,3]. Research suggests that they may have faster immunological recovery [30], decreased immune activation and exhaustion and better preservation of HIV-specific immunity [31], greater potential for post-treatment HIV control, and less opportunity for viral immune escape [32, 33] For these reasons, AHI people have long been of special interest for HIV prevention and treatment research [12, 34]. There is good reason to believe that limiting the establishment of HIV latent reservoirs in the body may be an initial, yet crucial step in the development of therapies that can consistently achieve HIV remission [39, 40] If this proves to be the case, AHI people [41,42,43] may be among the first to achieve long-term, post treatment control of HIV [44]
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