Quit 4 TB Trial project aims to assess in people with TB who smoke daily and check the effectiveness and cost effectiveness of mTB-Tobacco in achieving continuous abstinence for at least six months and also assess the effectiveness and cost effectiveness of mTB-Tobacco in enhancing TB treatment adherence and improving clinical outcomes. We will conduct a multi-center, cluster randomized, controlled trial consisting of four phases. Phase 1 involves consultation with Patients and Public Involvement (PPI) group about the study processes. PPI members will also review and provide feedback on the participant facing materials. Phase 2 is the pilot study. In Phase 3 (superiority trial), which will last for 12 months (6 months recruitments and 6 months follow ups), we will compare mTB-Tobacco (intervention A) with usual care (control). In Phase 4 (non-inferiority trial), which will last for another 12 months (6 months recruitment and 6 months follow ups), we will compare mTB-Tobacco (intervention A) with face-to-face behavioral support (intervention B). The primary endpoint will be biochemically verified continuous abstinence at 6 months post randomization. Abstinence is defined as self-report of not having used more than 5 cigarettes, bidis, water pipe sessions since the quit date, verified biochemically by a breath carbon monoxide (CO) reading of less than 10 ppm at month 6. Secondary outcomes will include Point abstinence, defined as a self-report of not using tobacco in the previous 7 days, assessed at week 9 and month 6, Adherence to TB Treatment, TB Programme outcomes, Cured, Completed treatment, Treatment failure, Defaulted, Died and Relapse cases.
Read the full article here: https://bmjopen.bmj.com/content/15/2/e089007
