Background
Methods
Study design
Study sites and inclusion criteria
Procedures
Adherence to anti-TB treatment
Collection of psychosocial and economic data
Case definitions
Statistical analyses
Role of the funding source
Results
Demographic, educational, and economic characteristics
Gugulethu TB clinic (Cape Town, South Africa) | Mabvuku polyclinc (Harare, Zimbabwe) | Kanyama TB clinic (Lusaka, Zambia) | St. Mary’s day clinic (Durban, South Africa) | Ifisi day clinic (Mbeya, Tanzania) | Overall | |
---|---|---|---|---|---|---|
Number of patients | 419 | 400 | 400 | 200 | 83 | 1502 |
Demographic and clinical information
| ||||||
Age [median (IQR)] | 39 (31–49) | 38 (32–45) | 35 (30–41) | 37 (30–50) | 37 (31–54) | 37 (30–46) |
Male (%) | 259 (62) | 185 (46) | 269 (67) | 104 (52) | 42 (51) | 859 (57) |
Previously had TB (%) | 178 (43) | 67 (17) | 85 (21) | 52 (26) | 2 (1) | 384 (26) |
HIV-infecteda (%) | 133 (32) | 324 (81) | 268 (67) | 121 (61) | 49 (59) | 895 (60) |
TB symptom score [TBscore; median (IQR)] | 4 (3–5) | 4 (3–5) | 5 (4–7) | 5 (4–6) | 7 (4–9) | |
Culture-confirmed TB cases (%) | 74 (18) | 77 (19) | 152 (38) | 35 (18) | 29 (35) | 367 (24) |
Kessler K-10 score | ||||||
Median (IQR)e | 20 (16–24) | 30 (25–35) | 16 (10–24) | 18 (15–22) | 29 (23–33) | 22 (16–29) |
Graded as severe (≥30) (%) | 31/413 (8) | 201/400 (50) | 49/399 (12) | 16/199 (8) | 38/74 (51) | 335 (22) |
Substance use
| ||||||
Tobacco smoker (%) | 249 (60) | 32 (8) | 92 (23) | 48 (24) | 9 (11) | 430 (28) |
Alcohol consumptionb (%) | ||||||
Never | 74 (18) | 252 (63) | 205 (51) | 119 (60) | 48 (58) | 698 (47) |
Social | 169 (40) | 86 (22) | 67 (17) | 49 (25) | 5 (6) | 376 (25) |
Regular | 120 (29) | 60 (15) | 82 (21) | 18 (9) | 30 (36) | 310 (21) |
Heavy | 20 (5) | 2 (1) | 46 (12) | 0 (0) | 0 (0) | 68 (5) |
Educational and psychosocial characteristics
| ||||||
Educational levelc (%) | ||||||
None | 7 (2) | 0 (0) | 35 (9) | 14 (7) | 28 (34) | 84 (6) |
Primary school | 65 (16) | 95 (24) | 178 (45) | 30 (15) | 46 (55) | 414 (28) |
Middle school | 249 (59) | 91 (23) | 6 (2) | 51 (26) | 0 (0) | 397 (26) |
High School | 3 (1) | 17 (5) | 164 (41) | 44 (22) | 2 (2) | 230 (15) |
Intermediate or post-high school diploma | 20 (5) | 52 (13) | 17 (4) | 60 (30) | 7 (8) | 156 (10) |
Graduate or post-graduate | 1 (0) | 11 (3) | 1 (0) | 6 (3) | 0 (0) | 19 (1) |
TB health literacy scored [median (IQR)] | 7 (5–9) | 5 (4–7) | 7 (4–9) | 7 (5–9) | 2 (1–4) | 6 (4–8) |
Economic characteristics
| ||||||
Unemployed or retiredf (%) | 280 (67) | 257 (64) | 144 (36) | 88 (44) | 55 (66) | 824 (55) |
Personal monthly incomeg (%) | ||||||
Tier 1 | 271 (65) | 222 (56) | 87 (22) | 22 (11) | 37 (45) | 639 (43) |
Tier 2 | 124 (30) | 104 (26) | 125 (31) | 102 (51) | 18 (22) | 473 (32) |
Tier 3 | 16 (4) | 44 (11) | 25 (6) | 23 (12) | 1 (1) | 109 (7) |
Tier 4 | 3 (<1) | 3 (<1) | 0 (0) | 10 (5) | 5 (6) | 21 (1) |
Household monthly incomeg (%) | ||||||
Tier 1 | 209 (50) | 123 (31) | 87 (22) | 22 (11) | 38 (46) | 479 (32) |
Tier 2 | 170 (41) | 165 (41) | 121 (30) | 98 (49) | 32 (39) | 586 (39) |
Tier 3 | 28 (7) | 80 (20) | 26 (7) | 26 (13) | 1 (1) | 161 (11) |
Tier 4 | 5 (1) | 31 (8) | 0 (0) | 11 (6) | 5 (6) | 52 (4) |
Psychological distress
Univariate analysis | Multivariate analysis | |||
---|---|---|---|---|
Crude estimate (95 % CI) | P-value | Adjusted estimate (95 % CI) | P-value | |
Demographic and clinical characteristics
| ||||
Age | 0.045 (0.010. 0.083) | 0.0132 | 0.031 (−0.003, 0.064) | 0.0702 |
Male | −2.499 (−3.371, −1.627) | <0.0001 | −1.447 (−2.278, −0.617) | 0.0007 |
Previously had TB | −0.541 (−1.561, 0.479) | 0.2987 | 0.980 (0.094, 1.866) | 0.0304 |
HIV-infected | 3.059 (2.172, 3.946) | <0.0001 | 0.061 (−0.763, 0.885) | 0.8844 |
TBscore | 0.698 (0.481, 0.914) | <0.0001 | 1.000 (0.802, 1.199) | <0.0001 |
Allocation arm Xpert MTB/RIF | −0.245 (−1.118, 0.628) | 0.5824 | - | - |
Culture-confirmed TB | −0.450 (−1.468, 0.568) | 0.3866 | - | - |
Substance use
| ||||
Tobacco smoker | −3.123 (−4.078, −2.169) | <0.0001 | - | - |
Alcohol consumption | ||||
Never | 1.00 (reference) | N/A | 1.00 (reference) | N/A |
Social | −3.124 (−4.203, −2.045) | <0.0001 | −0.599 (−1.592, 0.395) | 0.2378 |
Regular | −2.061 (−3.212, −0.910) | 0.0005 | −0.001 (−1.041, 1.039) | 0.9991 |
Heavy | −1.362 (−3.496, 0.773) | 0.2115 | 3.082 (1.256,4.907) | 0.0010 |
Educational characteristics
| ||||
Educational level | ||||
None | −6.496 (−10.722, −2.251) | 0.0027 | −1.667 (−5.155, 1.82) | 0.3489 |
Primary school | −3.751 (−7.664, 0.160) | 0.0604 | 0.420 (−2.771, 3.610) | 0.7966 |
Middle school | −5.224 (−9.140, −1.308) | 0.0090 | −0.528 (−3.762, 2.707) | 0.7492 |
High School | −4.792 (−8.700, −0.884) | 0.0164 | −0.324 (−3.508, 2.860) | 0.8418 |
Intermediate or post-high school diploma | −3.5906 (−7.674, 0.493) | 0.0850 | 0.988 (−2.378, 4.354) | 0.5651 |
Graduate or post-graduate | 0.00 (reference) | N/A | 0.00 (reference) | N/A |
TB health literacy score | −0.409 (−0.551, −0.267) | <0.0001 | - | - |
Economic characteristics
| ||||
Unemployed or retired | 2.877 (2.012, 3.742) | <0.0001 | - | - |
Personal monthly income | ||||
Tier 1 | 1.578 (−1.982, 5.139) | 0.3850 | - | - |
Tier 2 | −1.291 (−4.879, 2.296) | 0.4806 | - | - |
Tier 3 | −0.804 (−4.637, 3.028) | 0.6809 | - | - |
Tier 4 | 0.00 (reference) | N/A | - | - |
Household monthly income | ||||
Tier 1 | −1.802 (−4.187, 0.583) | 0.1389 | - | - |
Tier 2 | −2.352 (−4.718, 0.015) | 0.0516 | - | - |
Tier 3 | −2.066 (−4.676, 0.543) | 0.1209 | - | - |
Tier 4 | 0.00 (reference) | N/A | - | - |
Sites
| ||||
Cape Town | 0.565 (−0.637, 1.767) | 0.3569 | 1.525 (0.142, 2.907) | 0.0309 |
Harare | 10.648 (9.440, 11.856) | <0.0001 | 11.070 (9.802, 12.340) | <0.0001 |
Lusaka | −0.636 (−1.845, 0.574) | 0.3031 | −1.281 (−2.623, 0.061) | 0.0616 |
Mbeya | 8.423 (6.603, 10.243) | <0.0001 | 6.923 (4.9945, 8.911) | <0.0001 |
Durban | 0.00 (reference) | N/A | 0.00 (reference) | N/A |
Anti-TB treatment adherence
Univariate analysis | Multivariate analysis | |||
---|---|---|---|---|
Crude odds ratio (95 % CI) | P-value | Adjusted odds ratio (95 % CI) | P-value | |
Demographic and clinical characteristics
| ||||
Age | 0.997 (0.970, 1.024) | 0.8457 | 0.988 (0.947, 1.029) | 0.5563 |
Male | 0.859 (0.491, 1.517) | 0.5971 | 0.895 (0.402, 2.246) | 0.8951 |
Previously had TB | 0.729 (0.346, 1.445) | 0.3832 | - | - |
HIV-infected | 1.227 (0.693, 2.215) | 0.4889 | 1.358 (0.557, 3.421) | 0.5054 |
TBscore | 0.868 (0.748, 0.998) | 0.0524 | 0.639 (0.497, 0.797) | 0.0001 |
Allocation arm Xpert MTB/RIF | 2.038 (1.161, 3.648) | 0.0144 | 2.174 (0.985, 5.015) | 0.05993 |
K-10 score | 1.073 (1.039, 1.112) | <0.0001 | 1.082 (1.033, 1.137) | 0.0012 |
Substance use
| ||||
Tobacco smoker | 0.651 (0.325, 1.239) | 0.2055 | - | - |
Alcohol consumption | ||||
Never | 1.00 (reference) | N/A | 1.00 (reference) | N/A |
Social | 0.629 (0.296, 1.279) | 0.2122 | 0.505 (0.177, 1.364) | 0.1874 |
Regular | 0.701 (0.327, 1.435) | 0.3422 | 0.707 (0.243, 1.986) | 0.5137 |
Heavy | 2.371 (0.624, 9.029) | 0.1933 | 14.83 (2.083, 122.9) | 0.0090 |
Educational characteristics
| ||||
Educational level | ||||
None | 0.375 (0.030, 4.299) | 0.4167 | - | - |
Primary school | 0.500 (0.077, 4.022) | 0.4668 | - | - |
Middle school | 0.330 (0.049, 2.727) | 0.2539 | - | - |
High School | 0.684 (0.107, 5.428) | 0.6874 | - | - |
Intermediate or post-high school diploma | 0.789 (0.112, 6.743) | 0.81183 | - | - |
Graduate or post-graduate | 0.00 (reference) | N/A | - | - |
TB health literacy score | 0.885 (0.809, 0.967) | 0.0071 | 0.798 (0.696, 0.907) | 0.0008 |
Economic characteristics
| ||||
Unemployed or retired | - | - | ||
Personal monthly income | ||||
Tier 1 | * | 0.9839 | - | - |
Tier 2 | * | 0.9840 | - | - |
Tier 3 | * | 0.9838 | - | - |
Tier 4 | 1.00 (reference) | N/A | - | - |
Household monthly income | ||||
Tier 1 | 0.353 (0.102, 1.181) | 0.089747 | 0.288 (0.064, 1.264) | 0.0997 |
Tier 2 | 0.275 (0.082, 0.898) | 0.031567 | 0.350 (0.082, 1.445) | 0.1462 |
Tier 3 | 0.202 (0.039, 0.900) | 0.041743 | 0.156 (0.024, 0.922) | 0.0462 |
Tier 4 | 1.00 (reference) | N/A | 1.00 (reference) | N/A |
Sites
| ||||
Cape Town | 0.427 (0.121 1.593) | 0.1868 | - | - |
Harare | 3.709 (1.308, 12.285) | 0.01956 | - | - |
Lusaka | 1.036 (0.358, 3.461) | 0.9499 | - | - |
Mbeya | 0.900 (0.193, 3.980) | 0.8888 | - | - |
Durban | 1.00 (reference) | N/A | - | - |
Morbidity
Univariate analysis | Multivariate analysis | |||
---|---|---|---|---|
Crude estimate (95 % CI) | P-value | Adjusted estimate (95 % CI) | P-value | |
Demographic and clinical characteristics
| ||||
Age | 0.002 (−0.007, 0.010) | 0.7101 | −0.013 (−0.022, −0.003) | 0.0097 |
Male | 0.357 (0.156, 0.557) | 0.0005 | 0.263 (0.040, 0.486) | 0.0208 |
Previously had TB | 0.349 (0.124, 0.574) | 0.0024 | −0.228 (−0.491, 0.0353) | 0.0901 |
HIV-infected | −0.365 (−0.568, −0.162) | 0.0005 | 0.406 (0.163, 0.6493) | 0.0011 |
TBscore | 0.212 (0.157, 0.266) | <0.0001 | ||
Allocation arm Xpert MTB/RIF | 0.059 (−0.142, 0.261) | 0.5607 | - | - |
Culture-confirmed TB | 0.368 (0.128, 0.607) | 0.0027 | 0.587 (0.323, 0.850) | <0.0001 |
K-10 score | −0.045 (−0.056, −0.031) | <0.0001 | 0.041 (0.024, 0.057) | <0.0001 |
Substance use
| ||||
Tobacco smoker | 0.340 (0.127, 0.554) | 0.0018 | - | - |
Alcohol consumption | ||||
Never | 0.00 (reference) | N/A | - | - |
Social | 0.088 (−0.151, 0.327) | 0.4722 | - | - |
Regular | 0.264 (0.000, 0.527) | 0.0501 | - | - |
Heavy | 1.346 (0.816, 1.876) | <0.0001 | - | - |
Educational characteristics
| ||||
Educational level | ||||
None | 1.711 (0.742, 2.679) | 0.0006 | - | - |
Primary school | 1.075 (0.216, 1.933) | 0.0143 | - | - |
Middle school | 0.703 (−0.147, 1.552) | 0.1052 | - | - |
High School | 0.718 (−0.137, 1.572) | 0.1002 | - | - |
Intermediate or post-high school diploma | 0.404 (−0.492, 1.299) | 0.3771 | - | - |
Graduate or post-graduate | 0.00 (reference) | N/A | ||
TB health literacy score | 0.0450 (0.011, 0.079) | 0.0102 | - | - |
Economic characteristics
| ||||
Unemployed or retired | −0.087 (−0.293, 0.120) | 0.4105 | - | - |
Personal monthly income | ||||
Tier 1 | 0.271 (−0.578, 1.119) | 0.53181 | - | - |
Tier 2 | 0.354 (−0.503, 1.211) | 0.4180 | - | - |
Tier 3 | −0.066 (−0.977, 0.846) | 0.8879 | - | - |
Tier 4 | 0.00 (reference) | N/A | - | - |
Household monthly income | ||||
Tier 1 | 0.948 (0.427, 1.469) | 0.0004 | - | - |
Tier 2 | 0.749 (0.230, 1.269) | 0.0048 | - | - |
Tier 3 | 0.282 (−0.292, 0.855) | 0.3360 | - | - |
Tier 4 | 0.00 (reference) | N/A | - | - |
Sites
| - | - | ||
Cape Town | 0.322 (0.060, 0.585) | 0.01635 | −1.306 (−1.691, −0.921) | <0.0001 |
Harare | −0.926 (−1.198, −0.655) | <0.0001 | −0.471 (−0.883, −0.059) | 0.0253 |
Lusaka | 2.415 (2.091, 2.740) | <0.0001 | −2.393 (−2.822, −1.965) | <0.0001 |
Mbeya | 0.5904 (0.202, 0.979) | 0.0030 | 0.367 (−0.226, 0.960) | 0.2259 |
Durban | 0.00 (reference) | N/A | 0.00 (reference) | N/A |