The lived experience of participants in an African randomised trial

Lawrence, DORCID logo and (2023) The lived experience of participants in an African randomised trial. PhD thesis, London School of Hygiene & Tropical Medicine. DOI: 10.17037/PUBS.04670695
Copy

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.


picture_as_pdf
2022_ITD_PhD_Lawrence_D.pdf
subject
Accepted Version
Available under Creative Commons: Attribution-NonCommercial-No Derivative Works 4.0

View Download

Atom BibTeX OpenURL ContextObject in Span Multiline CSV OpenURL ContextObject Dublin Core Dublin Core MPEG-21 DIDL Data Cite XML EndNote HTML Citation JSON MARC (ASCII) MARC (ISO 2709) METS MODS RDF+N3 RDF+N-Triples RDF+XML RIOXX2 XML Reference Manager Refer Simple Metadata ASCII Citation EP3 XML
Export

Downloads