{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T22:48:57Z","timestamp":1779317337755,"version":"3.51.4"},"reference-count":42,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2021,4,5]],"date-time":"2021-04-05T00:00:00Z","timestamp":1617580800000},"content-version":"unspecified","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["RP-2017-08-ST2-012"],"award-info":[{"award-number":["RP-2017-08-ST2-012"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,3,23]]},"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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\u2013061); 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      :\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04296292\">NCT04296292<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-039191","type":"journal-article","created":{"date-parts":[[2021,4,5]],"date-time":"2021-04-05T11:30:41Z","timestamp":1617622241000},"page":"e039191","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04296292","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5439-4039","authenticated-orcid":false,"given":"David S","family":"Lawrence","sequence":"first","affiliation":[{"name":"Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana"},{"name":"Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katlego","family":"Tsholo","sequence":"additional","affiliation":[{"name":"Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agnes","family":"Ssali","sequence":"additional","affiliation":[{"name":"Social Aspects of Health Programme, MRC\/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zivai","family":"Mupambireyi","sequence":"additional","affiliation":[{"name":"Centre for Sexual Health and HIV\/AIDS Research, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5915-8126","authenticated-orcid":false,"given":"Graeme","family":"Hoddinott","sequence":"additional","affiliation":[{"name":"Desmond Tutu TB Centre, Stellenbosch University Faculty of Medicine and Health Sciences, Cape Town, Western Cape, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Nyirenda","sequence":"additional","affiliation":[{"name":"Malawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David B","family":"Meya","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute, Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiratidzo","family":"Ndhlovu","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas S","family":"Harrison","sequence":"additional","affiliation":[{"name":"Institute for Infection and Immunity, St George\"s University of London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph N","family":"Jarvis","sequence":"additional","affiliation":[{"name":"Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana"},{"name":"Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0583-5272","authenticated-orcid":false,"given":"Janet","family":"Seeley","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK"},{"name":"Social Aspects of Health Programme, MRC\/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,4,5]]},"reference":[{"key":"2025121515271819000_11.4.e039191.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2009.10.002"},{"key":"2025121515271819000_11.4.e039191.2","unstructured":"Epstein S . 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