A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03519425
• Date of registration: 26/04/2018
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi PROSPECT
• Scientific title: A Pragmatic Randomised Study to Optimise Screening, Prevention and Care for Tuberculosis in Malawi
• Date of first enrolment: November 15, 2018
• Target sample size: 1455
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03519425
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Malawi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Attends Study Clinic with an acute care episode

- 18 years of age or older on the day of clinic attendance

- Has symptoms of tuberculosis (cough of any duration)

- Is resident within urban Blantyre

- Provides informed consent to participate

Exclusion Criteria:

- Taking treatment for tuberculosis on the day of clinic attendance

- Has taken any treatment for tuberculosis in the 6-months prior to clinic attendance

- Is taking isoniazid preventive therapy

- Plans to move out of Blantyre to live elsewhere in the following 6-months



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hiv

Tuberculosis

Tuberculosis, Pulmonary

Intervention(s)

Other: Optimised HIV screening and linkage to care

Other: Optimised tuberculosis screening and linkage to care

Primary Outcome(s)

Time to tuberculosis treatment initiation [Time Frame: Measured at 56 days after randomisation]

Secondary Outcome(s)

Mortality [Time Frame: Measured at 56 days after randomisation]

Quality of life (EQ5D visual analogue scale) [Time Frame: Measured at 56 days after randomisation]

TB treatment outcome [Time Frame: Measured at 6-months after randomisation]

Time to antiretroviral therapy initiation [Time Frame: Measured at 56 days after randomisation]

Same day TB treatment initiation [Time Frame: Measured at 56 days after randomisation]

Undiagnosed/untreated HIV [Time Frame: Measured at 56 days after randomisation]

Quality of life (EQ5D utility score) [Time Frame: Measured at 56 days after randomisation]

Cost-effectiveness [Time Frame: Measured at 56 days after randomisation]

Undiagnosed/untreated microbiologically-confirmed pulmonary tuberculosis [Time Frame: Measured at 56 days after randomisation]

Secondary ID(s)

17-050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Liverpool

London School of Hygiene and Tropical Medicine

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

McGill University

University of Malawi College of Medicine