Background
Methods
Study sites
Data collection procedures
The intervention
Study end points
Effectiveness measurement
Cost description and estimation
Data analysis
Results
Characteristic | All patients N = 2564 | IPT group N = 1283 | Control group N = 1281 |
P value |
---|---|---|---|---|
Sex: Females [Number (%)] | 1949 (76.0) | 994(77.4) | 955(74.6) | 0.083 |
Mean age in years (±SD) | 38.6(10.3) | 39.4(±10.5) | 37.8(±10.1) | <0.001 |
Median BMI (IQR) | 22.8(7) | 23.1(6) | 22.7(6) | <0.001 |
Patients on ARV drugs [Number (%)] | 1913(75) | 982(76.5) | 931(72.7) | 0.025 |
Median ARV duration in months(IQR) aN=1893 | 28.0(37) | 31.0(38) | 23(36) | <0.001 |
Mean baseline CD4+ cells/μl (± SD), bN=2357 | 375 (±247) | 415(±261) | 330(±223) | <0.001 |
Patients completing 6 months of IPT [N (%)] | 1263(98) | 1263(98) | - | NA |
Patients developed TB during follow up [N (%)] | 13 (1.1) | 2 (0.2) | 11 (0.9) | 0.012 |
Number of deaths during follow up [N (%)] | 27 (0.5) | 3(0.2) | 24(1.9) | <0.001 |
Patients lost to follow up [N (%)] | 146(5.7) | 73(5.7) | 73(5.7) | 0.992 |
Patients transferred out [N (%)] | 110(4.3) | 31(2.4) | 79(6.2) | <0.001 |
Patients who withdrew consent [N (%)] | 13(0.5) | 10(0.8) | 3(0.2) | 0.052 |
Patients who completed study | 2268(88.5) | 1166 (90.9) | 1102 (86.0) | <0.001 |
IPT group | Control group | Number of cases averted per 100,000 persons | |
---|---|---|---|
Person years of follow up (PY) | 2205 | 2152 | |
TB incidence density/100,000 PY | 91 | 511 | 420 |
Mortality incidence density/100,000 PY | 136 | 1115 | 979 |
Cost parameter | Salary scale | Number in place | Unit cost (US $) | |
---|---|---|---|---|
IPT | Controls | |||
Personnel costs | ||||
Assistant medical officer | TGHS C | 6 | 6 | 567.64 |
Nurse | TGHS B | 1 | 0 | 278.37 |
Health attendant | PMOSS 1/1 | 2 | 2 | 391.25 |
Assistant nurse | TGHS A | 16 | 16 | 300.81 |
Nurse counsellors | PMGSS 4/1 | 8 | 8 | 727.98 |
Medical doctors | PMGSS 8/1 | 4 | 4 | 1309.09 |
Medical specialists | PMGSS 11/1 | 4 | 4 | 2418.00 |
Laboratory scientific officer | PMGSS 6/1 | 4 | 4 | 982.62 |
Laboratory technician | PMGSS 4/1 | 4 | 4 | 727.98 |
Pharmacist | PMGSS 6/1 | 4 | 4 | 982.62 |
Pharmacy technician | PMGSS 4/3 | 4 | 4 | 727.98 |
Laboratory costs | ||||
Sputum microscopy | 23 | 21 | 1.92 | |
Sputum culture | 23 | 21 | 9.62 | |
FBP | 23 | 21 | 3.84 | |
ESR | 23 | 21 | 1.28 | |
CXR | 23 | 21 | 12.83 | |
Average water bill per month | N/A | N/A | 295.04 | |
Average electricity bill per month | N/A | N/A | 577.26 | |
Estimated average clinic area (square metres) | 256 | 256 | 18a
| |
Number Trained on 3Is for 3 days | 33 | 32 | 358.80 |
Description Cost parameter | Cost in IPT group (US $) | Cost in the Control group (US $) | ||||
---|---|---|---|---|---|---|
1st year | 2nd year (3% discount) | Total cost for 2 years | 1st year | 2nd year (3% discount) | Total cost for 2 years | |
Clinic personnel | ||||||
Doctors | 225,317 | 218,754 | 444,071 | 216,074 | 213,057 | 429,131 |
Nurses | 197,738 | 191,978 | 389,716 | 175,074 | 169,974 | 345,048 |
Medical assistants | 44,890 | 43,583 | 88,473 | 40,810 | 39,621 | 80,431 |
Laboratory staff | 82,808 | 80,396 | 163,204 | 81,988 | 79,600 | 161,588 |
Pharmacy staff | 82,808 | 80,396 | 163,204 | 81,988 | 79,600 | 161,588 |
Laboratory tests | ||||||
Sputum smear | 27 | 17 | 44 | 21 | 19 | 40 |
Sputum culture | 134 | 86 | 220 | 106 | 96 | 202 |
Chest X-ray | 179 | 115 | 294 | 141 | 128 | 269 |
Full blood count | 54 | 35 | 89 | 42 | 38 | 81 |
ESR | 18 | 12 | 30 | 14 | 13 | 27 |
Medication costs | ||||||
INH (300 mg/day)b
| 94,807 | - | 94, 807 | - | - | - |
1st line anti-TB drugsc
| 265 | - | 265 | 927 | 514 | 1441 |
Utilities | ||||||
Water | 3885 | 3773 | 7658 | 3533 | 3430 | 6963 |
Electricity | 15,207 | 14,764 | 29,971 | 13,825 | 13,422 | 27,247 |
Recurrent costs | 0 | |||||
Clinic space | 60,826 | 59,054 | 119,880 | 55,296 | 53,685 | 108,981 |
Personnel training | 3819 | - | 3819 | 4177 | - | 4177 |
Total cost | 767,892 | 649,382 | 1,417,273 | 633,205 | 613,578 | 1,246,783 |
Incremental costd
| US$ 170,490 | |||||
ICER per TB case preventede
| US$ 405.93 per TB case prevented | |||||
ICER per death avertedf
| US$ 174.15 per death averted |
All patients | IPT group | Controls | |
---|---|---|---|
Number of enrolled patients in the two groups | 2564 | 1283 | 1281 |
Number of patients Completing 6 months of IPT | 1255 | 1255 | N/A |
Number of patients developed active TB during follow up | 13 | 2 | 11 |
Number of deaths occurred during follow up | 27 | 3 | 24 |
Estimated IPT effectiveness using incident TB
a
| 420 | N/A | N/A |
Estimated IPT effectiveness using all-cause mortality
b
| 979 | N/A | N/A |
Cost per person starting IPT
c
US $ | N/A | 132.88 | N/A |
Cost per person to complete 6 months of IPT
d
US $ | N/A | 135.85 | N/A |
Using +/− 10% sensitivity range | ICER per TB case prevented (US $) | ICER per death averted (US $) | ||||
---|---|---|---|---|---|---|
Parameter | Sensitivity range (+/−10%) | Sensitivity value | With Low value | With High value | With Low value | With High value |
1. Personnel cost | Low | 56,557 | 398.91 | 167.73 | ||
High | 69,125 | 429.44 | 180.57 | |||
2. Laboratory cost | Low | 53 | 405.91 | 174.14 | ||
High | 65 | 405.94 | 174.15 | |||
3. Medication cost | Low | 84,267 | 383.64 | 164.58 | ||
High | 102,993 | 428.22 | 183.71 | |||
4. Utilities cost | Low | 3078 | 405.11 | 173.80 | ||
High | 3762 | 406.74 | 174.50 | |||
5. Recurrent cost | Low | 9486 | 403.42 | 173.07 | ||
High | 11,594 | 408.44 | 175.22 | |||
6. TB cases prevented | Low | 378 | 451.03 | |||
High | 462 | 369.03 | ||||
7. Deaths averted | Low | 881 | 193.52 | |||
High | 1077 | 158.30 |