Clinical trial NCT04296292: The Lived Experience of Participants in an African Randomised Trial
Official title: The Lived Experience of Participants in an African Randomised Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Cryptococcal Meningitis
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: Infectious Diseases Institute, Uganda
name: University of Zimbabwe
First posted: 2020-03-05
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Experience and views of individuals involved in the AMBITION trial
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard AIDS Institute
city: Kampala
country: Uganda
facility: Infectious Diseases Institute, Uganda
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
References:
citation: 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.