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.

Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions

“…The evidence clearly recommends describing post-trial services in CT protocols and the informed consent form or offering additional assistance to help trial participants express their ambivalence or doubts about the challenges of a future transition to routine care [ 13 , 52 ]. Although current ethical guidelines propose obligations of CT researchers, such as the need to ensure continued access to necessary HIV treatments, psychosocial support and other services [ 37 ], PLWH are scared and worried when the transition to regular HIV care nears [ 37 , 41 ]. Evidence points to psychological stress related to loss of quality care and loss of material benefits, concerns about how to access care after exiting the trial, difficulties associated with linkage to care facilities, and difficulties in coping with treatment and transportation costs [ 37 , 38 ].…”

“…Although current ethical guidelines propose obligations of CT researchers, such as the need to ensure continued access to necessary HIV treatments, psychosocial support and other services [ 37 ], PLWH are scared and worried when the transition to regular HIV care nears [ 37 , 41 ]. Evidence points to psychological stress related to loss of quality care and loss of material benefits, concerns about how to access care after exiting the trial, difficulties associated with linkage to care facilities, and difficulties in coping with treatment and transportation costs [ 37 , 38 ]. CTs offer participants many advantages that are not found at the regular HIV care centers [ 41 ].…”