The Lived Experience of Participants in an African Randomised Trial

HIV Clinical Trial

— LEOPARD  

Official title:

The Lived Experience of Participants in an African Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296292
• Other study ID #: 17957
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: September 2020
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• HIV
• Meningitis
• Meningitis, Cryptococcal

Intervention

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

Locations

Country	Name	City	State
Botswana	Botswana Harvard AIDS Institute	Gaborone
Uganda	Infectious Diseases Institute, Uganda	Kampala
Zimbabwe	University of Zimbabwe	Harare

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Botswana Harvard AIDS Institute Partnership, Infectious Diseases Institute, Uganda, University of Zimbabwe

Countries where clinical trial is conducted

Botswana,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   LEOPARD Study on the LSHTM website