Acceptability of HIV cure-related trials: the challenges for physicians and people living with HIV (ANRS-APSEC)

ABSTRACT

Essential HIV cure-related clinical trials (HCRCT) have a potentially high-risk profile in terms of participants’ health, which could hinder enrollment by people living with HIV (PLWH) and healthcare professionals (HP). The ANRS-APSEC survey is part of the IAS “Towards an HIV cure” initiative, which promotes multidisciplinary research for a safe, affordable and scalable cure. The study objectives were to understand the psychosocial mechanisms underlying PLWH and HP viewpoints about future HCRCT. Six focus group discussions (three with PLWH (n = 21) and three with HP (n = 30)) were held in three French infectious disease units. From these, three perspectives on HCRCT were identified. The first involved beliefs and knowledge associating HCRCT with poorer health and quality of life for PLWH. The second concerned perceptions of HCRCT as a biological and epidemiological flashback to a situation when HIV infection was left uncontrolled. The third was characterized by aspects of historical HIV culture that embrace innovation.

KEYWORDS:

• Willingness to participate in clinical trials
• cure trial
• HIV history
• France

Acknowledgments

We thank all the PLWH involved, and all medical staff members in participating hospitals. We especially acknowledge the participating infectious disease units and principal investigators: Hôpital Bicêtre, Le Kremlin Bicêtre (Prs O. Lambotte and C. Goujard); CHU Mondor, Créteil (Pr J.-D. Lelièvre); CHU Hôtel-Dieu, Nantes (Pr F. Raffi). Finally, we thank Jude Sweeney for revising and editing the English version of the manuscript.

Ethics approval

The study was approved by CCTIRS (Comité consultatif sur le traitement de l’information en matière de recherche dans le domaine de la santé) and CNIL (Commission nationale de l’informatique et des libertés).

This research involves Human Participants.

Informed consent was obtained from all individual participants included in the study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Notes

1 All participants provided written informed consent. Patients receiving a stable ART regimen (≥6 months), with a sustained undetectable viral (≥3 years) and CD4 cell count >500 cells/mm³ were eligible.

2 Physicians and nurses participated on a voluntary basis.

Additional information

Funding

The ANRS APSEC survey was supported by ANRS (France Recherche Nord & sud Sida-hiv Hépatites).