Please do not leave us’ Qualitative excerpts of HIV-infected participants’perspectives towards a clinical trial endpoint in Tanzania. by Rose Mwangi1*, Maseke Mgabo2, Blandina Mmbaga3, Paul Ndebele4 Rachel Manongi5
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Abstract
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.
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