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

Nalubega, Sylivia; Cox, Karen; Mugerwa, Henry; Evans, Catrin

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Authors

Sylivia Nalubega

Karen Cox

Henry Mugerwa

Dr CATRIN EVANS CATRIN.EVANS@NOTTINGHAM.AC.UK
Professor of Evidence Based Healthcare



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.

Citation

Nalubega, S., Cox, K., Mugerwa, H., & Evans, C. (2021). Facilitated transition in HIV drug trial closure: A conceptual model for HIV post-trial care. PLoS ONE, 16(4), 1-15. https://doi.org/10.1371/journal.pone.0250698

Journal Article Type Article
Acceptance Date Apr 13, 2021
Online Publication Date Apr 29, 2021
Publication Date Apr 1, 2021
Deposit Date Apr 16, 2021
Publicly Available Date Apr 16, 2021
Journal PLoS ONE
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 16
Issue 4
Article Number e0250698
Pages 1-15
DOI https://doi.org/10.1371/journal.pone.0250698
Keywords Conceptual Model; Drug Trials; Facilitated Transition; HIV; Post-trial
Public URL https://nottingham-repository.worktribe.com/output/5468682
Publisher URL https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250698

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