Refusing to join a HIV cure clinical trial so as not to “break the carefree mindset about the disease”. Insights from a French qualitative study

1. Abstracts based on Formal Research Work
Sarah LEFEBVRE1 , Jean-Daniel LELIEVRE2, 3, Véronique RIEUX4, Laurence WEISS5, 6, Denise WARD7, Anne RACHLINE5, Morgane BUREAU-STOLTMANN1, Nadir GAAD2, Mohamed BEN MECHLIA4, Giorgio BARBARESCHI8, ϯGiulio MARIA CORBELLI9, Elizabeth BRODNICKI7, Bruno SPIRE1, Sheena MAC CORMACK7, Christel PROTIERE1
1 Aix Marseille Univ, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l’Information Médicale, ISSPAM, Marseille, France
2 VRI, Créteil, France
3 CHU Henri Mondor, APHP, Créteil, France
4 ANRS | Maladies infectieuses émergentes, France
5 Service d’Immunologie clinique, Hôtel Dieu, Paris, France
6 Université Paris Cité, Faculté de Santé, UFR de Médecine, Paris, France
7 MRC CTU, UCL, UK
8 European AIDS Treatment Group (EATG), Belgium
9 European AIDS Treatment Group (EATG), Italy

Abstract
Introduction

Accelerating scientific research on HIV cure/remission is a high priority. However, recruiting participants in HIV cure clinical trials (HCCT) can be challenging, as observed by the recent halt to the EHVA-T02/ANRS-VRI07 HCCT, a European randomized phase II placebo-controlled trial which included analytic treatment interruption (ATI). Our ongoing study AMEP-EHVA-T02 is the second in the world and the first in Europe to explore why people decide not to participate in HCCT with a view to improving recruitment in future HCCT.

Methods

This is an interpretive description-based qualitative research study. All persons (n=13) who refused to join EHVA-T02 in two collaborating French centres were invited to participate in semi-structured individual interviews to document their perceptions of HCCT, the context in which they had been invited to participate in EHVA-T02, their decision-making process, and their reasons for refusal. An inductive thematic analysis is currently underway.

Emerging findings

To date, five of the six persons who agreed to participate in our study have been interviewed (September 2022-January 2023). They were between 26 and 58 years old, and were diagnosed with HIV between 2 and 22 years prior to their interview. Four self-defined as men, one non-binary, three homosexual and two heterosexual. All were students or professionally active.

Despite being initially enthusiastic about participating in EHVA-T02 - their motivation to participate being driven by altruism and curiosity - all subsequently refused to participate without hesitation. Interestingly, refusal was not based on the fear of ATI or apprehension about the current COVID-19 pandemic context. Respondents seemed willing to accept some health risks, including viral load rebound, as they were reassured by the planned close monitoring. The primary reason for refusal was the constraints of the HCCT’s planned visits. Specifically, despite being perceived as essential, the follow-up intensity was incompatible with their professional/academic life, because visits were scheduled only during working hours. Three interviewees reported that this barrier could have been overcome with more timetable flexibility by the HCCT’s medical staff who “also have to make an effort”.

Other barriers to participation were more subtle and less obvious to overcome: regular visits to hospital could reveal their HIV status to others; regular visits could lead them to see themselves again as ill; ATI could lead to their having to “be careful again” by the need to re-implement their previous transmission risk prevention behaviours.
Four interviewees declared they did not feel the need for a cure as they lived a “normal life”: taking antiretroviral treatment was a non-burdensome routine for them, they felt fit, and were relieved that they no longer risked transmitting HIV. Consequently, they felt there would be a psychological burden if they participated in EHVA-T02. They did not want to experience the risk of having to “break the[ir] carefree mindset about the disease”.

Conclusion

Preliminary results suggest that recruitment in HCCT could be improved by scheduling follow-up appointments times which are compatible with an active lifestyle, but also by considering both the level of commitment required from the participant and the emotional impact related to participation.