Skip to main content
OpenTrials
Completed

NCT Number: NCT04296292

The Lived Experience of Participants in an African Randomised Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Cryptococcal Meningitis Cryptococcosis Infections Meningitis Meningitis, Cryptococcal Meningitis, Fungal Mycoses Nervous System Diseases Neuroinflammatory Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Botswana Harvard AIDS Institute, Gaborone, Botswana

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-depth interviews

Other

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

Other names: Direct observation

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Botswana Harvard AIDS Institute Partnership
  • Infectious Diseases Institute, Uganda
  • University of Zimbabwe

Registry information

Acronym: LEOPARD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.