The Lived Experience of Participants in an African Randomised Trial

Completed

• Conditions: HIV; Cryptococcal Meningitis
• Interventions: Other: In-depth interviews

• Registration Number: NCT04296292
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

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 Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Status Verified: 2020-09
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMBITION Researchers	In-depth interviews	Individuals working on the AMBITION trial
AMBITION Trial Participants	In-depth interviews	Individuals who have been enrolled into the AMBITION trial
The next-of-kin of AMBITION Trial Participants	In-depth interviews	Individuals who have provided consent for an AMBITION trial participant who had an abnormal mental status at baseline

Primary Outcome Measures

Name	Time	Method
Experience and views of individuals involved in the AMBITION trial	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.

Trial Locations

Locations (3)

Botswana Harvard AIDS Institute; 🇧🇼 Gaborone, Botswana

University of Zimbabwe; 🇿🇼 Harare, Zimbabwe

Infectious Diseases Institute, Uganda; 🇺🇬 Kampala, Uganda