The Lived Experience of Participants in an African Randomised Trial (LEOPARD)

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: HIV; Cryptococcal Meningitis

Treatments: Other: In-depth interviews

Study type: Observational

Funder types: Other

Identifiers

NCT04296292

17957

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

89 participants in 3 patient groups

AMBITION Trial Participants

Description:

Individuals who have been enrolled into the AMBITION trial

Treatment:

Other: In-depth interviews

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

Treatment:

Other: In-depth interviews

AMBITION Researchers

Description:

Individuals working on the AMBITION trial

Treatment:

Other: In-depth interviews