The Lived Experience of Participants in an African Randomised Trial

NCT04296292 | Completed

• 1 other identifier: 17957
• Study Type: observational
• Target: 89
• Locations: 3 countries
• Sites: 3

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.

Conditions

HIV; Cryptococcal Meningitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

AMBITION Trial Participants

Individuals who have been enrolled into the AMBITION trial

Other: In-depth interviews

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

Other: In-depth interviews

AMBITION Researchers

Individuals working on the AMBITION trial

Other: In-depth interviews

Interventions

In-depth interviews OTHER

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

Also known as: Direct observation

AMBITION Researchers; AMBITION Trial Participants; The next-of-kin of AMBITION Trial Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals enrolled onto the AMBITION trial and individuals who provided consent for them at the Gaborone, Kampala and Harare sites. Researchers working on AMBITION at the Gaborone, Kampala, Harare trial sites and also in the UK or France.

You may qualify if:

• 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

You may not qualify if:

• Nil
• The next-of-kin of AMBITION Trial Participants
• Provided surrogate consent for an individual who was enrolled into the AMBITION trial
• Willing and able to consent to the study
• Nil
• AMBITION Researchers
• Currently or previously employed on the AMBITION trial
• Willing and able to consent to the study
• Nil

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Botswana Harvard AIDS Institute Partnership: collaborator
• Infectious Diseases Institute, Uganda: collaborator
• University of Zimbabwe: collaborator

Study Sites (3)

Botswana Harvard AIDS Institute

Gaborone, Botswana

Location

Infectious Diseases Institute, Uganda

Kampala, Uganda

Location

University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (1)

• Lawrence DS, Tsholo K, Ssali A, Mupambireyi Z, Hoddinott G, Nyirenda D, Meya DB, Ndhlovu C, Harrison TS, Jarvis JN, Seeley J. The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis. BMJ Open. 2021 Apr 5;11(4):e039191. doi: 10.1136/bmjopen-2020-039191.

  PMID: 33820784 DERIVED

MeSH Terms

Conditions

Meningitis, Cryptococcal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: February 5, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: April 6, 2022

Record last verified: 2020-09

Locations

UG (1); ZI (1); BO (1)