Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medecins Sans Frontieres, Netherlands
• Collaborators: Don McKenzie Hospitals, Kwazulu Natal, South Africa; Doris Goodwin Hospitals, Kwazulu Natal, South Africa; London School of Hygiene and Tropical Medicine; Ministry of Health, Republic of Uzbekistan; Ministry of Public Health, Republic of Belarus; Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital; Republican specialised scientific-practical medical centre, Tashkent; Republican TB Hospital No. 2, Nukus; THINK TB & HIV Investigative Network; University of Sussex; Wits Health Consortium (Pty) Ltd
• Treatments: Bedaquiline; Clofazimine; Linezolid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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