Clinical trial NCT03942354: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
Official title: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multidrug Resistant Tuberculosis
Keywords: Quality of life, drug-resistant tuberculosis
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
Collaborators: name: University of Sussex
name: London School of Hygiene and Tropical Medicine
name: THINK TB & HIV Investigative Network
name: Wits Health Consortium (Pty) Ltd
name: Ministry of Public Health, Republic of Belarus
name: Ministry of Health, Republic of Uzbekistan
First posted: 2019-05-08
Enrollment: 137
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: This is an observational sub-study of parent RCT TB-PRACTECAL (NCT02589782. Arms 1 \& are the study population, and a sub-set of the main RCT cohort.

Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years are also included.

Brief summary: PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.

Detailed description: Tolerability of drugs for TB is a complex and dynamic course for patients with drug resistance and can be affected by many different factors. A deeper understanding of the perspectives and experience of men and women participating in novel TB treatment trials will add to the understanding of the safety and efficacy of treatment.

TB-PRACTECAL is a multicentre, open label, phase 2-3 randomised controlled trial evaluating exclusively oral 6 months regimens containing bedaquiline, pretomanid, linezolid +/- moxifloxacin or clofazimine for the treatment of microbiologically confirmed pulmonary M/XDR-TB. It is registered with the ClinicalTrials.gov with identifier number NCT02589782. The trial aims to recruit 630 adults from two sites in Uzbekistan (Nukus and Tashkent) and one site each from Belarus and South Africa.

The TB-PRACTECAL trial assumes that even if the investigational arms would have non-inferior efficacy and safety compared to the standard of care outcomes, patients would prefer a shorter, exclusively oral regimen with a lower pill count. This study therefore aims to describe patient experiences (i.e. the quality of the treatment experience as opposed to the quantity of treatment or the amount of time spent on it).

The PRACTECAL-PRO sub-study aims to answer the question: "What are the perceptions, expectations and experiences of novel TB treatment for adult patients participating in a six-month regimen clinical trial in Uzbekistan, South Africa and Belarus?"

The objectives for the analysis are:

* To compare baseline scores between trial patients (all interventional arm patients plus standard of care patients) with healthy controls.
* To assess changes in scores over time in patients on the intervention arms and patients on the standard of care arm.
* To assess the utility of the SF 12 and SGRQ in a TB clinical trial.

Eligibility criteria: Inclusion Criteria:

* Patients recruited into the TB-PRACTECAL trial in the approved sites OR
* Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years AND
* Literate in the study questionnaire languages
* Able to sign the sub-study informed consent form after agreeing to the additional interviews and completion of questionnaires.

Exclusion Criteria:

* TB patients excluded from TB-PRACTECAL clinical trial
* Healthy volenteers with co-morbidities
* Healthy volenteers found to have TB

Primary outcomes:
measure: Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 12 months
timeFrame: 12 months
measure: Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
city: Pietermaritzburg
country: South Africa
facility: Doris Goodwin Hospital
state: KwaZulu Natal
city: Durban
country: South Africa
facility: THINK Clinical Trial Unit, Hillcrest
state: KwaZulu-Natal
city: Johannesburg
country: South Africa
facility: Helen Jospeh Hospital
city: Nukus
country: Uzbekistan
facility: Republican TB Hospital No. 2
state: Karakalpakstan
city: Tashkent
country: Uzbekistan
facility: Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital
Study officials:
affiliation: MSF
name: Beverley Stringer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stringer B, Lowton K, James N, Nyang'wa BT. Capturing patient-reported and quality of life outcomes with use of shorter regimens for drug-resistant tuberculosis: mixed-methods substudy protocol, TB PRACTECAL-PRO. BMJ Open. 2021 Sep 6;11(9):e043954. doi: 10.1136/bmjopen-2020-043954.