The Lived Experience of Participants in an African Randomised Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Lived Experience of Participants in an African Randomised Trial

Conditions
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HIV, Cryptococcal Meningitis

Intervention / Treatment
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* Other: In-depth interviews


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AMBITION Trial Participants<br>Individuals who have been enrolled into the AMBITION trial | Other: In-depth interviews<br>* In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites<br>* Other names: Direct observation;|
| The next-of-kin of AMBITION Trial Participants<br>Individuals who have provided consent for an AMBITION trial participant who had an abnormal mental status at baseline | Other: In-depth interviews<br>* In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites<br>* Other names: Direct observation;|
| AMBITION Researchers<br>Individuals working on the AMBITION trial | Other: In-depth interviews<br>* In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites<br>* Other names: Direct observation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience and views of individuals involved in the AMBITION trial | 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 |