The experiences of clinical research staff during an HIV cure trial with an analytical treatment interruption in Durban, South Africa.

BACKGROUND

HIV cure trials involving analytical treatment interruptions (ATIs) are expanding in resource-limited settings where HIV prevalence is highest, such as South Africa. Given the socio-economic challenges in these regions, ATI-inclusive trials may present unintended mental health risks to trial participants. To ensure participant safety, tailored mental health support should be part of the routine study implementation. While there is a trend toward more participant-centred study designs, less attention is focused on clinical research staff and their perceptions on managing participants with pre-existing or emerging trauma.

METHOD: We explored the perspectives of clinical research staff at Females Rising through Education Support and Health (FRESH) involved in an ATI-inclusive study, by conducting in-depth interviews (IDIs). Interviews were audio-recorded, transcribed and analysed thematically.

RESULTS

Clinical staff reported that participants were optimistic and hopeful about their involvement. However, staff expressed concerns about the psychological impact of going through the ATI, which was associated with emotional distress and, for some, triggered pre-existing trauma. The intersection of prior trauma and heightened anxiety around viral rebound warranted specific mental health support. Staff who counselled participants on HIV disclosure identified common barriers that hindered HIV status disclosure and trial participation. Staff expressed the need for specialised training to support participants' mental health.

CONCLUSIONS

Including participant-centred psychosocial support in the design of ATI-inclusive HIV cure trials may improve study adherence and retention while protecting participants' mental health. Equipping clinical research staff with trauma-informed competencies should be considered a minimum standard in ATI-inclusive trials settings.