Background
Methods
Study design and participants
Randomization and masking
Procedures
Primary outcomes
Secondary outcomes
Statistical analysis
Results
Baseline characteristics
Variables | Categories | f (%) | Arm | |
---|---|---|---|---|
Intervention f (%) | Control f (%) | |||
Gender | Female | 40 (35.1) | 18 (31.6) | 22 (38.6) |
Male | 74 (64.9) | 39 (68.4) | 35 (61.4) | |
Marital status | Never | 54 (47.4) | 27 (47.4) | 27 (47.4) |
Married | 51 (44.7) | 29 (50.9) | 22 (38.6) | |
Widowed | 2 (1.8) | 0 (0) | 2 (3.5) | |
Divorced | 7 (6.1) | 1 (1.8) | 6 (10.5) | |
Occupation status | No job | 23 (20.2) | 10 (17.5) | 13 (22.8) |
Student | 4 (3.5) | 4 (7.0) | 0 (0) | |
Farmer | 1 (0.9) | 0 (0) | 1 (1.8) | |
Trader | 10 (8.8) | 5 (8.8) | 5 (8.8) | |
Housewife | 9 (7.9) | 2 (3.5) | 7 (12.3) | |
Government employee | 10 (8.8) | 5 (8.8) | 5 (8.8) | |
Daily laborer | 45 (39.5) | 22 (38.6) | 23 (40.4) | |
Other | 12 (10.5) | 9 (15.8) | 3 (5.3) | |
Highest level of education | No formal education | 9 (7.9) | 3 (5.3) | 6 (10.5) |
Primary | 44 (38.6) | 25 (43.9) | 19 (33.3) | |
Secondary | 30 (26.3) | 14 (24.6) | 16 (28.1) | |
Preparatory | 11 (9.6) | 5 (8.8) | 6 (10.5) | |
University diploma | 9 (7.9) | 4 (7.0) | 5 (8.8) | |
University diploma or above | 11 (9.6) | 6 (10.5) | 5 (8.8) | |
Residential status | Lives alone | 14 (12.3) | 6 (10.5) | 8 (14.0) |
Lives with family | 84 (73.7) | 43 (75.4) | 41 (71.9) | |
Lives with friends | 7 (6.1) | 3 (5.3) | 4 (7.0) | |
Homeless | 6 (5.3) | 3 (5.3) | 3 (5.3) | |
Other | 3 (2.6) | 2 (3.5) | 1 (1.8) | |
Number of cohabitants | ≤ 3 | 67 (58.8) | 36 63.2) | 31 (54.4) |
4–6 | 38 (33.3) | 17 (29.8) | 21 (36.8) | |
7–9 | 7 (6.1) | 2 (3.5) | 5 (8.8) | |
≥ 10 | 2 (1.8) | 2 (3.5) | 0 (0) | |
Bedrooms | 1 | 72 (63.2) | 37 (64.9) | 35 (61.4) |
2 | 30 (26.3) | 14 (24.6) | 16 (28.1) | |
3 | 7 (6.1) | 4 (7.0) | 3 (5.3) | |
≥ 4 | 5 (4.4) | 2 (3.5) | 3 (5.3) | |
Household head | Yes | 63 (55.3) | 33 (57.9) | 30 (52.6) |
No | 51 (44.7) | 24 (42.1) | 27 (47.4) | |
Residency status | Permanent | 92 (80.7) | 43 (75.4) | 49 (85.9) |
Temporary | 22 (19.3) | 14 (24.6) | 8 (14.0) | |
Smoking per day | Never | 94 (82.5) | 50 (87.7) | 44 (77.2) |
1–5 | 19 (16.7) | 6 (10.5) | 13 (22.8) | |
6–10 | 1 (0.9) | 1 (1.8) | 0 (0) | |
Khat (a stimulant) | Never | 91 (79.8) | 47 (82.5) | 44 (77.2) |
1/week | 10 (8.8) | 3 (5.3) | 7 (12.3) | |
> = 2/week | 9 (7.9) | 5 (8.8) | 4 (7.0) | |
1/month | 4 (3.5) | 2 (3.5) | 2 (3.6) | |
Alcohol | Never | 72 (63.2) | 40 (70.2) | 32 (56.1) |
> 1/day | 12 (10.5) | 5 (8.8) | 7 (12.3) | |
2–5/day | 19 (16.7) | 7 (12.3) | 12 (21.1) | |
≥ 6/day | 3 (2.6) | 1 (1.8) | 2 (3.5) | |
Rarely | 8 (7.0) | 4 (7.0) | 4 (7.0) | |
HIVa | Negative | 96 (85.0) | 47 (82.5) | 49 (87.5) |
Positive | 17 (15.0) | 10 (17.5) | 7 (12.5) | |
On antiretroviral (If HIV positive) | Yes | 12 (73.3) | 7 (70.0) | 5 (71.4) |
No | 5 (26.7) | 3 (30.0) | 2 (28.6) | |
TB treatment | New | 102 (89.5) | 50 (87.7) | 52 (91.2) |
Relapse | 12 (10.5) | 7 (12.3) | 5 (8.8) | |
Place of diagnosis | Study facility | 78 (68.4) | 36 (63.2) | 42 (73.7) |
Health center | 4 (3.5) | 2 (3.5) | 2 (3.5) | |
Public hospital | 10 (8.8) | 8 (14.0) | 2 (3.5) | |
Private clinic/hospital | 21 (18.4) | 10 (17.5) | 11 (19.3) | |
Other | 1 (0.9) | 1 (1.8) | 0 (0) | |
TB test methodology | Microscopy | 44 (38.6) | 18 (31.6) | 26 (45.6) |
Xpert MTB/RIF | 70 (61.4) | 39 (68.4) | 31 (54.4) | |
Microscopy result (if test with microscopy)b | 1–9 (scanty) | 1 (2.4) | 0 (0) | 1 (4.0) |
1+ | 10 (23.8) | 5 (29.4) | 5 (20.0) | |
2+ | 15 (35.7) | 10 (58.8) | 5 (20.0) | |
3+ | 16 (38.1) | 2 (11.8) | 14 (56.0) | |
Completed treatment (if ever treated for TB) | Yes | 12 (100) | 7 (100) | 5 (100) |
Adherence to TB medications
Adherence primary analysis
Arm | Adherence GM % | GSD | MR (95%CI) | P value |
---|---|---|---|---|
Intervention (n = 57) | 99.01 | 1.02 | 1.00 (0.99-1.01) | 0.954 |
Control (n = 57) | 98.97 | 1.04 | 1 |
Adherence level | Categories | Study arm | P value | |
---|---|---|---|---|
Intervention, f (%) | Control, f (%) | |||
≥ 90% | Achieved | 57 (100) | 55 (96.5)a | 0.496 |
Not achieved | 0 (0) | 2 (3.5) | ||
≥ 80% | Achieved | 57 (100) | 57 (100) | NA |
Not achieved | 0 (0) | 0 (0) |
Variables | Categories (n) | GM (GSD) | CMR (95%CI) | P value | AMR (95%CI) | P value |
---|---|---|---|---|---|---|
Arm | Intervention (57) | 99.01 (1.02) | 1.00 (0.99–1.01) | 0.928 | 0.99 (0.98–1.00) | 0.189 |
Control (56) | 98.97 (1.04) | 1 | 1 | |||
Sociodemographic characteristics | ||||||
Gender | Female (40) | 99.11 (1.02) | 1.00 (0.99–1.01) | 0.749 | ||
Male (73) | 98.92 (1.03) | 1 | ||||
Age | - | 0.99 (0.99–1.00) | 0.136 | 0.99 (0.99–1.00) | 0.218 | |
Marital status | Married (51) | 99.40 (1.02) | 1.01 (0.99–1.02) | 0.175 | 1.01 (0.99–1.02) | 0.116 |
Unmarried (62) | 98.65 (1.04) | 1 | 1 | |||
Occupation | No job (36) | 97.93 (1.05) | 0.98 (0.97–0.99) | 0.006 | 0.99 (0.98–0.99) | 0.023 |
Have job (77) | 99.49 (1.02) | 1 | 1 | |||
Education | Below prep (82) | 98.74 (1.03) | 0.99 (0.98–1.00) | 0.160 | 0.99 (0.98–1.00) | 0.214 |
Prep and above (31) | 99.61 (1.01) | 1 | 1 | |||
# of people | ≤3 (66) | 99.13 (1.02) | 1.00 (0.99–1.01) | 0.509 | ||
≥4 (47) | 98.76 (1.04) | 1 | ||||
# of bedrooms | 1 (71) | 99.03 (1.02) | 1.00 (0.99–1.01) | 0.823 | ||
≥2 (42) | 98.90 (1.04) | 1 | ||||
Household head | No (50) | 98.90 (1.03) | 0.99 (0.98–1.01) | 0.788 | ||
Yes (63) | 99.06 (1.03) | 1 | ||||
Residency | Permanent (91) | 98.99 (1.03) | 0.99 (0.98–1.01) | 0.995 | ||
Temporary (22) | 98.99 (1.02) | 1 | ||||
Behavioral characteristics | ||||||
Smoking per day | Never (94) | 99.06 (1.03) | 1.00 (0.99–1.02) | 0.565 | ||
Yes (19) | 98.63 (1.03) | 1 | ||||
Khat | Never (91) | 98.90 (1.03) | 0.99 (0.98–1.01) | 0.578 | ||
Yes (22) | 99.29 (1.02) | 1 | ||||
Alcohol | Never (72) | 99.15 (1.02) | 1.00 (0.99–1.02) | 0.442 | ||
Yes (41) | 98.69 (1.04) | 1 | ||||
Disease conditions | ||||||
HIV | Negative (96) | 99.31 (1.02) | 1.02 (1.01–1.04) | 0.005 | 1.02 (1.01–1.04) | 0.003 |
Positive (17) | 97.21 (1.06) | 1 | 1 | |||
TB treatment | New (102) | 98.97 (1.03) | 0.99 (0.98–1.02) | 0.778 | ||
Relapse (11) | 99.22 (1.02) | 1 | ||||
At least one -ve urine isoniazid | No (100) | 99.31 (1.02) | 1.03 (1.01–1.05) | <0.001 | 1.03 (1.01–1.04) | 0.001 |
Yes (13) | 96.47 (1.07) | 1 | 1 |
Adherence secondary analysis
Adherence sensitivity analysis based on pill count
Variables | Categories (n) | Mean (SD) | CRR (95%CI) | P value |
---|---|---|---|---|
Arm | Intervention (57) | 59.44 (1.29) | 1.00 (0.95–1.05) | 0.985 |
Control (56) | 59.41 (1.97) | 1 | ||
Sociodemographic characteristics | ||||
Gender | Female (40) | 59.48 (1.19) | 1.00 (0.95–1.05) | 0.959 |
Male (73) | 59.39 (1.87) | 1 | ||
Age | - | 1.00 (0.99–1.00) | 0.773 | |
Marital status | Married (51) | 59.65 (1.02) | 1.01 (0.96–1.06) | 0.781 |
Unmarried (62) | 59.24 (2.02) | 1 | ||
Occupation | No job (36) | 58.81 (2.49) | 0.99 (0.94–1.04) | 0.559 |
Have job (77) | 59.71 (0.96) | 1 | ||
Education | Below prep (82) | 59.29 (1.88) | 0.99 (0.94–1.05) | 0.992 |
Prep and above (31) | 59.77 (0.76) | 1 | ||
# of people | ≤ 3 (66) | 59.52 (1.35) | 1.00 (0.96–1.05) | 0.883 |
≥ 4 (47) | 59.29 (2.02) | 1 | ||
# of bedrooms | 1 (71) | 59.45 (1.38) | 1.00 (0.95–1.05) | 0.963 |
≥ 2 (42) | 59.38 (2.06) | 1 | ||
Household head | No (50) | 59.36 (1.51) | 0.99 (0.95–1.05) | 0.937 |
Yes (63) | 59.48 (1.78) | 1 | ||
Residency | Permanent (91) | 59.43 (1.72) | 1.00 (0.94–1.06) | 0.992 |
Temporary (22) | 59.41 (1.40) | 1 | ||
Behavioral characteristics | ||||
Smoking per day | Never (94) | 59.48 (1.62) | 1.00 (0.94–1.07) | 0.920 |
Yes (19) | 59.26 (1.88) | 1 | ||
Khat | Never (91) | 59.37 (1.77) | 0.99 (0.94–1.06) | 0.886 |
Yes (22) | 59.63 (1.05) | 1 | ||
Alcohol | Never (72) | 59.51 (1.19) | 1.00 (0.96–1.06) | 0.871 |
Yes (41) | 59.27 (2.27) | 1 | ||
Disease conditions | ||||
HIV | Negative (96) | 59.59 (1.19) | 1.02 (0.95–1.09) | 0.580 |
Positive (17) | 58.47 (3.10) | 1 | ||
TB treatment | New (102) | 59.40 (1.72) | 0.99 (0.92–1.08) | 0.924 |
Relapse (11) | 59.63 (0.92) | 1 | ||
At least one -ve urine isoniazid | No (100) | 59.61 (1.06) | 1.03 (0.95–1.11) | 0.479 |
Yes (13) | 58.00 (3.72) | 1 |
Variables | Categories (n) | Mean (SD) | CRR (95%CI) | P value | ARR (95%CI) | P value |
---|---|---|---|---|---|---|
Arm | Intervention (57) | 59.44 (1.29) | 1.19 (1.09–1.29) | <0.001 | 1.16 (1.07–1.26) | <0.001 |
Control (56) | 49.98 (14.68) | 1 | 1 | |||
Sociodemographic characteristics | ||||||
Gender | Female (40) | 53.15 (14.21) | 0.96 (0.89–1.02) | 0.162 | 1.02 (0.95–1.09) | 0.658 |
Male (73) | 55.63 (9.45) | 1 | 1 | |||
Age | - | 0.99 (0.99–1.00) | 0.140 | 0.99 (0.99–1.00) | 0.704 | |
Marital status | Married (51) | 55.88 (10.29) | 1.04 (0.98–1.10) | 0.229 | ||
Unmarried (62) | 53.82 (12.18) | 1 | ||||
Occupation | No Job (36) | 50.00 (15.99) | 0.88 (0.79–0.97) | 0.007 | 0.89 (0.82–0.98) | 0.012 |
Have job (77) | 56.97 (7.54) | 1 | 1 | |||
Education | Below Prep (82) | 53.77 (12.82) | 0.94 (0.88–1.00) | 0.061 | 0.93 (0.86–1.02) | 0.108 |
Prep and above (31) | 57.35 (5.38) | 1 | 1 | |||
# of people | ≤ 3 (66) | 56.00 (10.95) | 1.06 (0.99–1.12) | 0.082 | 1.04 (0.98–1.11) | 0.225 |
≥ 4 (47) | 53.00 (11.82) | 1 | 1 | |||
# of bedrooms | 1 (71) | 54.72 (10.95) | 0.99 (0.94–1.06) | 0.959 | ||
≥ 2 (42) | 54.81 (12.17) | 1 | ||||
Household head | No (50) | 53.76 (12.09) | 0.97 (0.91–1.03) | 0.299 | ||
Yes (63) | 55.54 (10.79) | 1 | ||||
Residency | Permanent (91) | 54.37 (11.52) | 0.97 (0.89–1.04) | 0.368 | ||
Temporary (22) | 56.31 (10.81) | 1 | ||||
Behavioral characteristics | ||||||
Smoking per day | Never (94) | 55.05 (10.84) | 1.03 (0.95–1.12) | 0.430 | ||
Yes (19) | 53.26 (13.91) | 1 | ||||
Khat | Never (91) | 54.65 (11.83) | 0.99 (0.92–1.07) | 0.804 | ||
Yes (22) | 55.18 (9.42) | 1 | ||||
Alcohol | Never (72) | 55.09 (11.19) | 1.02 (0.96–1.08) | 0.591 | ||
Yes (41) | 54.15 (11.78) | 1 | ||||
Disease conditions | ||||||
HIV | Negative (96) | 54.39 (11.82) | 0.96 (0.88–1.04) | 0.322 | ||
Positive (17) | 56.76 (8.36) | 1 | ||||
TB treatment | New (102) | 54.35 (11.86) | 0.93 (0.84–1.03) | 0.157 | 0.97 (0.87–1.07) | 0.502 |
Relapse (11) | 58.45 (3.05) | 1 | 1 | |||
At least one -ve urine isoniazid | No (100) | 56.01 (10.19) | 1.24 (1.12–1.37) | < 0.001 | 1.15 (1.00–1.31) | 0.043 |
Yes (13) | 45.08 (15.31) | 1 | 1 |
IsoScreenTM urine Isoniazid test
Variable | Categories | 4x urine isoniazid test result | RR (95% CI) | p-value | |
---|---|---|---|---|---|
≥1 neg f (%) | 4x pos f (%) | ||||
Treatment arm | Intervention | 2 (3.5) | 55 (96.5) | 1 | 0.022 |
Control | 11 (19.3) | 46 (80.7) | 5.50 (1.28–23.71) | ||
Total | 13 (11.4) | 101 (88.6) |