The psychology of “cure” - unique challenges to consent processes in HIV cure research in South Africa

Abstract

BackgroundConsent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research.MethodsIn total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted.ResultsThe majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants.ConclusionUnique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.

Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366

“…Scholars have discouraged the use of the word ''cure'' entirely in study-related documents to avoid participant misconceptions about the potential for cure from these early-phase investigations. 17,27 Using terms that more precisely describe the mechanisms being studied (e.g., latency reversal) can go a long way in setting realistic expectations [28][29][30] but can also at times be overly technical. Biomedical HIV cure research teams must also ensure adequate comprehension from study participants to ensure they are joining studies for appropriate reasons.…”

“…32 Undoubtedly, biomedical HIV cure research teams should appreciate the psychological dimensions of HIV cure-related research participation. 19,27 As bioethicists have previously posited, it is possible that participants' seemingly high expectations of clinical benefits may simply have reflected their hopes. 26,33 The surveys also revealed general understanding of the associated risks and benefits, but some lack of recall about specific details.…”

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

“…Furthermore, the margin of risk that ought to be tolerated by withdrawing ART even temporarily and under rigorous monitoring is smaller than in the early days of the HIV epidemic when no life‐saving option was available . Preliminary supportive BSSR revealed a complex matrix of demographic, experiential, psychosocial, ethical, logistical, economic and evidence‐based factors influencing decisions to participate in HIV cure research . Supportive BSSR could also help understand how insights from PLHIV, and relevant stakeholders, are collectively constructed, and how these could in turn strengthen the design and outcomes of biomedically focused clinical trials.…”

Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection

“…Previous research has highlighted people’s experiences during AHI [ 8 – 10 , 66 , 68 , 73 , 74 , 81 , 92 ], the ethics of HIV treatment [ 93 – 95 ] and prevention [ 96 – 101 ], and the ethics of clinical research generally [ 102 – 104 ]. Additionally, much work has been dedicated to clinical research ethics for studies involving adults living with HIV [ 36 , 59 , 105 – 110 ], including issues related to informed consent [ 111 – 116 ], analytical treatment interruption (ATI) [ 60 , 87 , 109 , 117 – 119 ], and risks versus benefits [ 120 – 128 ]. Following these efforts, we suggest three primary domains of potential ethical concern for HIV remission clinical studies involving AHI participants.…”

“…If researchers recognize these issues from the outset, they can plan to provide more interactive and much longer than usual sessions for informed consent [ 72 ] and/or incorporate tests of understanding and informed consent comprehension enhancement strategies [ 131 – 136 ]. If concerns around psychosocial issues arise, referral mechanisms for mental health services [ 116 ] should be included in a protocol's design and budget.…”