Abstract:
BACKGROUND : Consent 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.
METHODS : In 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.
RESULTS : The 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.
CONCLUSION : Unique 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.
