HIVLEOPARDNCT04296292
The Lived Experience of Participants in an African Randomised Trial
An observational study of HIV and Cryptococcal Meningitis, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Cryptococcal Meningitis
- What is being tested?
- In-depth interviews
- How many people
- 89 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Feb 2020to 11 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Provided surrogate consent for an individual who was enrolled into the AMBITION trial
- Willing and able to consent to the study
- Currently or previously employed on the AMBITION trial
- Willing and able to consent to the study
Who cannot join
- Nil
- The next-of-kin of AMBITION Trial Participants
- Nil
- AMBITION Researchers
- Nil
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
Read the 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.
- Conditions
- HIV, Cryptococcal Meningitis
- Being tested
- In-depth interviews
- Medical subject headings
- Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-depth interviewsOther
Also called Direct observation
In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites
| Study group | Role | What they receive |
|---|---|---|
| AMBITION Trial Participants | Individuals who have been enrolled into the AMBITION trial Receives: 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 Receives: Other: In-depth interviews | |
| AMBITION Researchers | Individuals working on the AMBITION trial Receives: Other: In-depth interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start5 Feb 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Infectious Diseases Institute, Uganda, University of Zimbabwe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296292
- Sponsor's protocol ID
- 17957
- Acronym
- LEOPARD
- Status last verified
- Sep 2020
- First submitted
- 3 Mar 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual transcripts and field notes may be shared with other researchers upon request and agreement by investigators.
Publications
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.
PubMed 33820784
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lived Experience of Participants in an African Randomised Trial
- ClinicalTrials.gov ID
- NCT04296292
- Acronym / sponsor ID
- LEOPARD / 17957
- Conditions
- HIV, Cryptococcal Meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Infectious Diseases Institute, Uganda, University of Zimbabwe
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMBITION Trial Participants | – | Other: In-depth interviewsIndividuals who have been enrolled into the AMBITION trial |
| The next-of-kin of AMBITION Trial Participants | – | Other: In-depth interviewsIndividuals who have provided consent for an AMBITION trial participant who had an abnormal mental status at baseline |
| AMBITION Researchers | – | Other: In-depth interviewsIndividuals working on the AMBITION trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Provided surrogate consent for an individual who was enrolled into the AMBITION trial
- Willing and able to consent to the study
Key exclusion criteria (5 listed)
- Nil
- The next-of-kin of AMBITION Trial Participants
- Nil
- AMBITION Researchers
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-depth interviewsAlso: Direct observationIn-depth interviews following a narrative line of enquiry and direct observation at each of the research sites | Other | AMBITION Researchers, AMBITION Trial Participants, The next-of-kin of AMBITION Trial Participants |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 33820784Lawrence 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.
- Individual participant dataSharing planned: Undecided. Individual transcripts and field notes may be shared with other researchers upon request and agreement by investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Cryptococcal Meningitis, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Botswana, Uganda, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience and views of individuals involved in the AMBITION trial (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.