HIV Clinical Trial
— LEOPARDOfficial title:
The Lived Experience of Participants in an African Randomised Trial
NCT number | NCT04296292 |
Other study ID # | 17957 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 5, 2020 |
Est. completion date | June 11, 2021 |
Verified date | September 2020 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Botswana | Botswana Harvard AIDS Institute | Gaborone | |
Uganda | Infectious Diseases Institute, Uganda | Kampala | |
Zimbabwe | University of Zimbabwe | Harare |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Botswana Harvard AIDS Institute Partnership, Infectious Diseases Institute, Uganda, University of Zimbabwe |
Botswana, Uganda, Zimbabwe,
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. |
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