Table 2.
SPIRIT Figure
| STUDY PERIOD | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolment | Allocation | During Treatment Months | Post Treatment Months | |||||||||
| TIMEPOINT | − 1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 3 | 6 | 9 | 12 |
| ENROLMENT: | ||||||||||||
| Eligibility screen | X | |||||||||||
| Informed consent | X | |||||||||||
| Chest X-Ray | X | |||||||||||
| HIV Testing | X | |||||||||||
| Urine pregnancy test | X | |||||||||||
| Allocation | X | |||||||||||
| INTERVENTIONS: | ||||||||||||
| Weekday DOT & weekend self-report | X | X | X | X | X | X | X | |||||
| PK/PD evaluationa | X | |||||||||||
| Sputum specimensb | X | X | X | X | X | |||||||
| Blood specimensc | X | |||||||||||
| ASSESSMENTS: | ||||||||||||
| Side effects screen | X | X | X | X | X | X | ||||||
| TLFB | X | X | X | X | X | X | X | X | X | X | X | |
| Behavioral Assessmentd | X | X | X | X | ||||||||
| TB Symptom Screen | X | X | X | X | ||||||||
aThe PK/PD visit is completed between weeks 4 and 8 of treatment for the Aim 2 cohort only
bCollected during screening, then weekly for weeks 1–12 of treatment, with a final specimen at month 5
cBlood is drawn at the initial visit for complete blood count (CBC), alanine transaminase (ALT) and aspartate transaminase (AST), albumin, creatinine (Cr), international normalized ratio (INR), and partial thromboplastin time (PTT), hemoglobin A1c (HbA1c) and Phosphatidylethanol (PEth). In the event of a positive side effect screen, the following levels will be reassessed: assessed in the event of a positive side effect screen: Complete blood count (CBC), alanine transaminase (ALT) and aspartate transaminase (AST), and creatinine (Cr)
dThe behavioral assessment includes Fagerstrom, AUDIT, DUDIT, CES-D and Household Hunger Screening