- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296292
The Lived Experience of Participants in an African Randomised Trial (LEOPARD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Individuals enrolled onto the AMBITION trial and individuals who provided consent for them at the Gaborone, Kampala and Harare sites.
Researchers working on AMBITION at the Gaborone, Kampala, Harare trial sites and also in the UK or France.
Description
AMBITION Trial Participants
Inclusion Criteria:
- Enrolled onto the AMBITION trial and has completed at least six weeks of follow-up
- Not currently confused
- Willing and able to consent to the study
Exclusion Criteria:
- Nil
The next-of-kin of AMBITION Trial Participants
Inclusion Criteria:
- Provided surrogate consent for an individual who was enrolled into the AMBITION trial
- Willing and able to consent to the study
Exclusion Criteria:
- Nil
AMBITION Researchers
Inclusion Criteria:
- Currently or previously employed on the AMBITION trial
- Willing and able to consent to the study
Exclusion Criteria:
- Nil
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AMBITION Trial Participants
Individuals who have been enrolled into the AMBITION trial
|
In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites
Other Names:
|
The next-of-kin of AMBITION Trial Participants
Individuals who have provided consent for an AMBITION trial participant who had an abnormal mental status at baseline
|
In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites
Other Names:
|
AMBITION Researchers
Individuals working on the AMBITION trial
|
In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experience and views of individuals involved in the AMBITION trial
Time Frame: 18 months
|
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. Interviews 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. Direct observations will help to contextualise the findings from the interviews by situating them within the clinical environment. |
18 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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