Table 6.
Reasons for non-completion of study follow-up by region and by regimen
North-America (n = 771) | Non North-America (n = 70) | |||
---|---|---|---|---|
3HP-DOT* (n = 363) | 9H-SAT* (n = 408) | 3HP-DOT* (n = 30) | 9H-SAT* (n = 40) | |
Reason | n (%) | n (%) | n (%) | n (%) |
Withdrew consent (n = 139) | 58 (16.0) | 72 (17.6) | 6 (20.0) | 3(7.5) |
Developed active TB (n = 5)† | 3 (0.83) | 2 (0.49) | — | — |
Refusal of further follow-up (n = 7) | 4 (1.1) | 3 (0.74) | — | — |
Lost to follow-up (n = 410)‡ | 187 (51.5) | 194 (47.5) | 11 (36.7) | 18 (45.0) |
Other (n = 147) | 56 (15.4) | 76 (18.6) | 7 (23.3) | 8 (20.0) |
Missing (n = 133) | 55 (15.2) | 61 (15.0) | 6 (20.0) | 11 (27.5) |
Total (n = 841) | 363 (47.1) | 408 (52.8) | 30 (42.9) | 40 (57.1) |
3HP-DOT = 3 months of directly observed once-weekly RPT (maximum dose, 900 mg) plus INH (maximum dose, 900 mg); 9H-SAT = 9 months of daily self-administered INH (maximum dose, 300 mg).
Classified as 3HP-DOT probable clinical TB in adult (n=2), spine disease (discitis) not characteristic of TB spondylitis (n = 1)and 9H-SAT probable clinical TB in adult (n = 2).
3 participants in the 3HP group and 4 in the 9H group died after month 33, and were lost at the last follow-up evaluation. They were therefore added to the lost to follow-up category.
H, INH = isoniazid; P, RPT = rifapentine; DOT = directlyobserved therapy; SAT = self-administered treatment.