Table 2.
Attribute | Definition |
Treatments | The primary analyses are based on the following comparisons: (a) Arm 3 vs Arm 1—that is, 3HP+routine treatment support vs 3HR+routine treatment support (b) Arm 5 vs Arm 1—that is, 1HP+routine treatment support vs 3HR+routine treatment support (c) Arm 2 vs Arm 1—that is, 3HR+additional treatment support vs 3HR+routine treatment support If comparison (a) shows 3HP improves adherence compared with 3HR, then additional treatment support will be formally tested for 3HP by comparing Arm 4 vs Arm 3—that is, 3HP+additional treatment support vs 3HP+routine treatment support. Additional treatment support will be similarly assessed for 1HP. |
Population | Adults aged 16–65 years diagnosed with LTBI and eligible for LTBI treatment. |
Endpoint | Adequate treatment adherence, defined as taking ≥90% of allocated doses within the allowable time frame. |
Intercurrent events | The main intercurrent events and how they will be handled in the estimand are as follows:
|
Population-level summary measure | Risk ratio for adequate treatment adherence comparing the relevant arms. |
LTBI, latent tuberculosis infection.