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Ethical and practical considerations in HIV drug trial closure

Perspectives of research staff in Uganda

Bibliographic Data

ID21787554
AuthorsSylivia Nalubega (0000-0002-0756-5819, Soroti University, corresponding author), Karen Cox (0000-0002-8621-3773, University of Kent), Henry Mugerwa (0000-0003-0575-754X, Joint Clinical Research Centre), Catrin Evans (0000-0002-5338-2191, University of Nottingham)
Year2021
Volume17
Issue4
Pages423-434
Publication date2021-10-01
Open AccessYes
TypeARTICLE
VenueResearch Ethics (JOURNAL)
Journal identifiersISSN: 1747-0161 • E-ISSN: 2047-6094
PublisherSAGE Publications (PUBLISHER • US)
DOI10.1177/17470161211030971
OpenAlexW3098952459
LanguageEN
Citations received1
References cited15

There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settings. This research aimed to establish how research staff in Uganda understood and practised post-trial care for HIV positive trial participants. A grounded theory study was conducted using in-depth individual interviews and focus group discussions with 22 research staff from three different trials in Uganda. The results indicated that researchers engaged in three main activities to support trial participants, including: (i) preparing for post-trial care, which included instituting trial closure guidelines, planning necessary resources, and informing trial participants about post-trial care; (ii) facilitating participants during trial exit by engaging in psychological and practical support activities and (iii) providing follow up care and support for participants after trial exit, to respond to the needs of trial participants which often arose after trial exit. This study established a need for a holistic approach to post-trial-care of HIV positive trial participants in Uganda, and the need to engage multiple stakeholders including ethics authorities

Clinical trial · Drug trial · Family medicine · Focus group · Political science · Randomized controlled trial · Sociology · Ethics in Clinical Research · HIV, Drug Use, Sexual Risk · HIV/AIDS Research and Interventions · Medicine · Nursing · Surgery

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Citations per year1
Citation span2025 - 2025 (1)
Highly citedNo

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Open DOIOpen Access
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