Work

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

Year: 2021

Type: article

Abstract: 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 3 different trials in Uganda, in 2014-2015. 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.

Source: Research Ethics

DOI: 10.1177/17470161211030971

Authors: Sylivia Nalubega, Karen Cox, Henry Mugerwa, Catrin Evans

Institutions: Soroti University, University of Kent, University of Nottingham, Joint Clinical Research Centre

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: