Facilitated transition in HIV drug trial closure: a conceptual model for HIV post-trial care

Abstract

Within the HIV clinical trial field, there are gaps in existing ethical regulations in relation to post-trial care. There is need to develop post-trial care guidelines that are flexible and sensitive to local contexts and to the specific needs of different groups of participants, particularly in low income contexts. Evidence regarding HIV trial closure and post-trial care is required to underpin the development of appropriate policies in this area. This article reports research from Uganda that develops a new model of ‘Facilitated Transition’ to conceptualize the transition process of HIV positive trial participants from ‘research’ to ‘usual care’ health facilities after trial conclusion. This was a qualitative grounded theory study that included 21 adult HIV positive post-trial participants and 22 research staff, undertaken between October 2014 and August 2015. The findings showed that trial closure is a complex process for HIV positive participants which includes three phases: the pre-closure, trial-closure, and post-trial phases. The model highlights a range of different needs of research participants and suggests specific and person-centred interventions that can be delivered at different phases with the aim of improving health outcomes and experiences for trial participants in low income settings during trial closure. Further research needs to be done to verify the model in other contexts and for other conditions.

Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

“…In addition to these, research staff in this study have recommended the need for: more person-centred post-trial care taking into account the psychological needs of participants; a more active researcher-led linkage to care approach; researcher (and other stakeholder) engagement with trial participants following trial exit; and a more person-centred approach to the provision of trial feedback. The proposed approach is further detailed in the Model of Facilitated Transition in HIV Drug Trial Closure (Nalubega et al, 2021) and is recommended for HIV trial closure practice in Uganda and related settings.…”

“…The study adopted a qualitative, constructive grounded theory approach (Charmaz, 2014), which resulted in construction of a model of 'Facilitated Transition' to guide post-trial practice -reported in another paper (Nalubega et al, 2021).…”

“…Authors in the field of HIV have recommended the need to address a range of post-trial care needs of research participants including ensuring continued access to required HIV treatments, psychosocial support and other services, (Cho et al, 2018;Nalubega et al, 2019Nalubega et al, , 2021Vallely et al, 2009). Despite these recommendations, a gap in research regulation appears to exist whereby available policy guidelines are too generic and do not emphasise key aspects of research ethics which appear essential to some stakeholders (Kwagala et al, 2010).…”