Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
Study NCT ID:
NCT04296292
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Lived Experience of Participants in an African Randomised Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience and views of individuals involved in the AMBITION trial', 'timeFrame': '18 months', 'description': 'Interviews with AMBITION trial participants and their next-of-kin will be semi-structured and follow a loose interview guide that adopts a narrative approach to understand the experience of being diagnosed with HIV-associated cryptococcal meningitis, being approached and enrolling into the trial, undergoing invasive procedures, completing follow-up and then exiting the trial. Interviews will take place during and after the trial.\n\nInterviews with researchers will follow a thematic line of enquiry to understand how the trial can be improved for participants as well as how transnational research partnerships could be optimised for the benefit of researchers.\n\nDirect observations will help to contextualise the findings from the interviews by situating them within the clinical environment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV', 'Cryptococcal Meningitis']}, 'referencesModule': {'references': [{'pmid': '33820784', 'type': 'DERIVED', 'citation': 'Lawrence DS, Tsholo K, Ssali A, Mupambireyi Z, Hoddinott G, Nyirenda D, Meya DB, Ndhlovu C, Harrison TS, Jarvis JN, Seeley J. 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. 2021 Apr 5;11(4):e039191. doi: 10.1136/bmjopen-2020-039191.'}]}, 'descriptionModule': {'briefSummary': 'There has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. The investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of HIV-associated cryptococcal meningitis.', 'detailedDescription': 'Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable and this is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, a poor healthcare infrastructure and the fear of death. Where patients are confused or unconscious the responsibility for this decision falls on the relatives. The objectives of this study are to learn from the experience of participants, relatives and researchers involved in a randomised controlled trial, AMBITION (ISRCTN 72509687), which is testing a novel treatment approach for HIV-associated cryptococcal meningitis and is recruiting participants from multiple sites across sub-Saharan Africa.\n\nThe investigators will collect data from trial participants and their relatives who provided consent on their behalf in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach and encourage the drawing of timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. In addition, interviews will take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Findings from the interviews will be prospectively fed back to the individual sites and Trial Management Group to improve the ongoing trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals enrolled onto the AMBITION trial and individuals who provided consent for them at the Gaborone, Kampala and Harare sites.\n\nResearchers working on AMBITION at the Gaborone, Kampala, Harare trial sites and also in the UK or France.', 'healthyVolunteers': True, 'eligibilityCriteria': 'AMBITION Trial Participants\n\nInclusion Criteria:\n\n* Enrolled onto the AMBITION trial and has completed at least six weeks of follow-up\n* Not currently confused\n* Willing and able to consent to the study\n\nExclusion Criteria:\n\n* Nil\n\nThe next-of-kin of AMBITION Trial Participants\n\nInclusion Criteria:\n\n* Provided surrogate consent for an individual who was enrolled into the AMBITION trial\n* Willing and able to consent to the study\n\nExclusion Criteria:\n\n* Nil\n\nAMBITION Researchers\n\nInclusion Criteria:\n\n* Currently or previously employed on the AMBITION trial\n* Willing and able to consent to the study\n\nExclusion Criteria:\n\n* Nil'}, 'identificationModule': {'nctId': 'NCT04296292', 'acronym': 'LEOPARD', 'briefTitle': 'The Lived Experience of Participants in an African Randomised Trial', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'The Lived Experience of Participants in an African Randomised Trial', 'orgStudyIdInfo': {'id': '17957'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AMBITION Trial Participants', 'description': 'Individuals who have been enrolled into the AMBITION trial', 'interventionNames': ['Other: In-depth interviews']}, {'label': 'The next-of-kin of AMBITION Trial Participants', 'description': 'Individuals who have provided consent for an AMBITION trial participant who had an abnormal mental status at baseline', 'interventionNames': ['Other: In-depth interviews']}, {'label': 'AMBITION Researchers', 'description': 'Individuals working on the AMBITION trial', 'interventionNames': ['Other: In-depth interviews']}], 'interventions': [{'name': 'In-depth interviews', 'type': 'OTHER', 'otherNames': ['Direct observation'], 'description': 'In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites', 'armGroupLabels': ['AMBITION Researchers', 'AMBITION Trial Participants', 'The next-of-kin of AMBITION Trial Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Botswana Harvard AIDS Institute', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Infectious Diseases Institute, Uganda', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual transcripts and field notes may be shared with other researchers upon request and agreement by investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Botswana Harvard AIDS Institute Partnership', 'class': 'OTHER'}, {'name': 'Infectious Diseases Institute, Uganda', 'class': 'OTHER'}, {'name': 'University of Zimbabwe', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}