Lawrence, DS; (2023) The lived experience of participants in an African randomised trial. PhD thesis, London School of Hygiene & Tropical Medicine. DOI: https://doi.org/10.17037/PUBS.04670695
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Abstract
Background: The AMBITION-cm trial aimed to define a novel treatment approach for HIV associated cryptococcal meningitis. I aimed to explore inclusion and representation in trials for cryptococcal meningitis, and to critically interpret qualitative data around clinical trials for life-threatening illnesses. I then used ethnographic methods to explore the lived experience of those involved in the AMBITION-cm trial. Methods: I systematically searched research databases and performed a meta-analysis of clinical trials for cryptococcal meningitis, and a critical interpretive synthesis of qualitative data collected from participants in trials from life-threatening illnesses. I embedded an ethnographic study within AMBITION-cm in Botswana and Uganda, utilising in-depth interviews and direct observations and analysed data thematically. Results: In the meta-analysis, 39 papers were included. Trials had evolved with the epidemiology of cryptococcal meningitis, however severe and relapse cases were underrepresented, as were female researchers and researchers from LMICs in authorship. Twenty-two papers were included in the critical interpretive synthesis to produce a synthetic construct describing how the life-threatening illness overwhelmingly impacts decision making. Eighty-nine individuals were recruited into the ethnographic study. Pathways to care were extremely convoluted and I identified multiple recommendations for improvement. Participants had a complex decision-making process to navigate, and decisions were made based on a therapeutic expectation from the trial. The AMBITION-cm regimen was acceptable to patients and providers. Conclusions: Trials for cryptococcal meningitis are typically conducted in line with the epidemiology of the disease however some groups are under-represented. There are significant gaps in routine healthcare systems for people living with advanced HIV. Challenges in managing cryptococcal meningitis may be averted by the convenience and acceptability of the AMBITION-cm regimen. The life-threatening nature of an illness has a critical impact on the experience of enrolling into a trial and the decision to enrol in AMBITION-cm was based on a therapeutic expectation.
Item Type | Thesis |
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Thesis Type | Doctoral |
Thesis Name | PhD |
Contributors | Seeley, J and Jarvis, J |
Faculty and Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
Funder Name | National Institute for Health and Care Research, The European Developing Countries Clinical Trials Partnership (EDCTP),, Swedish International Development Cooperation Agency (SIDA), Wellcome Trust / Medical Research Council (UK) / UKAID Joint Global Health Trials. |
Copyright Holders | David Stephen Lawrence |
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Filename: 2022_ITD_PhD_Lawrence_D.pdf
Licence: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
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