‘Please do not leave us’ Qualitative excerpts of HIV-infected participants’ perspectives towards a clinical trial endpoint in Tanzania

Introduction: The field of bioethics lacks empirical evidence to support the debates surrounding human involvement in clinical investigations. We focused on HIV clinical trials to explore participants’ perceptions and experiences towards clinical trial endpoints. Methods: This qualitative multiple case study used in-depth interviews (IDIs), and case narratives to collect data. IDIs were conducted with HIV study participants at the Care and Treatment Centers (CTC) and the Child Centred Family Care Clinic (CCFCC) until data saturation was achieved. The interviews covered motivations for participation, perceived risks and benefits, and trial endpoint expectations. Additionally, participants were also encouraged to provide relevant recommendations. Results: A total of 18 in-depth interviews were conducted with individuals visiting CTC and CCFCC for various reasons including routine medication, voluntary counselling and testing, for visits as mandated by clinical trials, or as caretakers/guardians accompanying their children to HIV clinic for prevention of mother to child (PMTCT) programs. Participants reported different reasons for their motivation to participate in clinical trials. They perceived no risks involved in participating in clinical trials and highlighted financial benefits and high-quality healthcare received from health workers during the clinical trial at the period of participation. However, at the exit of the study, all participants expressed uncertainties about their fate and their children after the trials. Participants wished to continue accessing post-trial medical services similar to the one provided during the clinical trials even after being linked to other health facilities for standard care. They appreciated friendly service, regular professional advice, and follow-up of their health during the clinical trials. Conclusion: Our findings show that although at the end of the trial, patients are linked to standard care, continuation of supportive measures after the trial is also essential. Our findings highlight the importance of providing post-trial benefits for participants in HIV studies as a basic ethical practice such as intervention treatment, professional advice, and devices found beneficial to participants. Further research should focus on participants’ transition to standard care and their post-trial coping strategies.