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

Abstract

IntroductionIndividuals 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 analysisWe 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 disseminationThis 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 registrationRegistered at www.clinicaltrials.gov:NCT04296292.

Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi

“…The findings here also imply that RECs should more closely examine what supporting and deliberative mechanisms are put in place by Trial Teams across the life of trials. Extending this work, it will be informative to compare the current study findings drawn from a community-based trial with participant experiences from clinical settings [ 43 ]…”

Pathways to care with HIV-associated cryptococcal meningitis in Botswana and Uganda: Findings from a qualitative methods study

“…We embedded an ethnographic study entitled The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD) within the AMBITION-cm trial at the Gaborone, Botswana and Kampala, Uganda sites ( Lawrence et al, 2021b ). In Botswana the participants were recruited at Princess Marina Hospital and in Kampala at Kiruddu Referral Hospital.…”

The acceptability of the AMBITION-cm treatment regimen for HIV-associated cryptococcal meningitis: Findings from a qualitative methods study of participants and researchers in Botswana and Uganda

“…We embedded an ethnographic study entitled The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD) within the AMBITION-cm trial at the Gaborone, Botswana and Kampala, Uganda sites [ 23 ]. Through LEOPARD we aimed to understand the experience of participating in the AMBITION-cm trial from a range of different perspectives.…”

“…We conducted a qualitative methods study with the aim of understanding the acceptability of the AmBisome regimen compared with the standard of care from both the participant and the researcher perspective. We embedded an ethnographic study entitled The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD) within the AMBITION-cm trial at the Gaborone, Botswana and Kampala, Uganda sites [23]. Through LEOPARD we aimed to understand the experience of participating in the AMBITION-cm trial from a range of different perspectives.…”