The Lived Experience of Participants in an African Randomised Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2021-06-11

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.

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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.

Conditions

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HIV Cryptococcal Meningitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AMBITION Trial Participants

Individuals who have been enrolled into the AMBITION trial

In-depth interviews

Intervention Type OTHER

In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites

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

Intervention Type OTHER

In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites

AMBITION Researchers

Individuals working on the AMBITION trial

In-depth interviews

Intervention Type OTHER

In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites

Interventions

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In-depth interviews

In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites

Intervention Type OTHER

Other Intervention Names

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Direct observation

Eligibility Criteria

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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

* Provided surrogate consent for an individual who was enrolled into the AMBITION trial
* Willing and able to consent to the study

* Currently or previously employed on the AMBITION trial
* Willing and able to consent to the study