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The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis.

Lawrence, DS; Tsholo, K; Ssali, A; Mupambireyi, Z; Hoddinott, G; Nyirenda, D; Meya, DB; Ndhlovu, C; Harrison, TS; Jarvis, JN; et al. Lawrence, DS; Tsholo, K; Ssali, A; Mupambireyi, Z; Hoddinott, G; Nyirenda, D; Meya, DB; Ndhlovu, C; Harrison, TS; Jarvis, JN; Seeley, J (2021) The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis. BMJ Open, 11 (4). e039191. ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2020-039191
SGUL Authors: Harrison, Thomas Stephen

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Abstract

INTRODUCTION: Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable. This is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, poor healthcare infrastructure and fear of death. Where patients are confused or unconscious the responsibility for this decision falls to relatives. This qualitative study is nested in the ongoing AMBIsome Therapy Induction OptimisatioN (AMBITION) Trial. AMBITION is recruiting participants from five countries in sub-Saharan Africa and is trialling a novel treatment approach for HIV-associated cryptococcal meningitis, an infection known to affect brain function. We aim to learn from the experiences of participants, relatives and researchers involved in AMBITION. METHODS AND ANALYSIS: We will collect data through in-depth interviews with trial participants and the next of kin of participants who were confused at enrolment and therefore provided surrogate consent. Data will be collected in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach including participatory drawing of participation timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. Interviews will also take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Interviews will be transcribed verbatim, translated (if necessary) and organised thematically for narrative analysis. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Development Committee, Gaborone (Reference: HPDME:13/18/1); Makerere School of Health Sciences Institutional Review Board, Kampala (Reference: 2019-061); University of Zimbabwe Joint Research Ethics Committee, Harare (Reference: 219/19), and the London School of Hygiene and Tropical Medicine (Reference: 17957). Study findings will be shared with research participants from the sites, key stakeholders at each research institution and ministries of health to help inform the development and implementation of future trials. The findings of this study will be published in journals and presented at academic meetings. TRIAL REGISTRATION: Registered at www.clinicaltrials.gov:NCT04296292.

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Keywords: HIV & AIDS, clinical trials, qualitative research
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: BMJ Open
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
5 April 2021Published
23 March 2021Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
RP-2017–08-ST2-012National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 33820784
Web of Science ID: WOS:000638218000009
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/113272
Publisher's version: https://doi.org/10.1136/bmjopen-2020-039191

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