Background
Methods
Study setting
Study design and population
Data collection procedures
Variables measurements
Statistical analysis
Results
Baseline characteristics of study participants
Variable, N = 367 | N | Percent (%) | |
---|---|---|---|
Age | 0–5 | 269 | 73.30 |
6–15 | 83 | 22.62 | |
15–18 | 15 | 4.09 | |
Sex | Male | 175 | 47.68 |
Female | 192 | 52.32 | |
WHO clinical stage | I & II | 136 | 37.06 |
III & IV | 231 | 62.94 | |
Nutritional statusa (n = 335) | Within normal limits | 166 | 49.55 |
Mild malnutrition | 26 | 7.76 | |
Moderate malnutrition | 61 | 18.21 | |
Severe malnutrition | 82 | 24.48 | |
CD4 absolute count | <500 cells/ml | 109 | 29.70 |
> = 500 cells/ml | 258 | 70.30 | |
Baseline viral load (copies/ml)b
| 5000–100,000 | 102 | 27.79 |
100,000–500,000 | 107 | 29.16 | |
500,000–1,000,000 | 52 | 14.17 | |
≥1,000,000 | 106 | 28.88 | |
Haemoglobin level, gm/dl (n = 271) | 0–8 | 42 | 15.50 |
8–16 | 229 | 84.50 |
Variable | Undetectable viral load, N = 367 |
P value | |
---|---|---|---|
Yes, n (%) | No, n (%) | ||
Sex | 0.908 | ||
Male | 91 (47.4) | 84 (48.0) | |
Female | 101 (52.6) | 91 (52.0) | |
Age group | 0.163 | ||
0–5 | 133 (69.3) | 136 (77.7) | |
6–15 | 49 (25.5) | 34 (19.4) | |
15–18 | 10 (5.2) | 5 (2.9) | |
Timing of ART initiation | 0.065 | ||
Within 7 days | 103 (53.7) | 77 (44.0) | |
Beyond 7 days | 89 (46.3) | 98 (56.0) | |
Mean baseline weight (SD) | 14.4 (14.0) | 11.1 (9.4) | 0.007* |
Baseline creatinine level | 28.6 (11.2) | 27.6 (12.0) | 0.705 |
Baseline haemoglobin level | 10.02 (1.9) | 9.57 (1.64) | 0.020* |
Adherence on ART | 0.001* | ||
Good adherence (Pill count based) (≥3 consecutive visits) | 38 (19.8) | 72 (41.1) | |
Inconsistent adherence | 154 (80.2) | 103 (58.9) | |
Baseline Nutrition status | 0.745 | ||
Normal limits & mild malnutrition | 102 (53.1) | 90 (51.4) | |
Moderate & severe malnutrition | 90 (46.9) | 85 (48.6) | |
TB status | 0.067 | ||
Positive | 15 (7.8) | 24 (13.7) | |
Negative | 177 (92.2) | 151 (86.3) | |
Baseline ART regimen | 0.121 | ||
Nevirapine based | 66 (34.4) | 77 (44.0) | |
Efavirenz based | 44 (22.9) | 28 (16.0) | |
Protease Inhibitor based | 75 (39.1) | 60 (34.3) | |
Triple RTI | 7 (3.7) | 10 (5.7) | |
WHO clinical stage | 0.089 | ||
I & II | 79 (41.2) | 57 (32.6) | |
III & IV | 113 (58.8) | 118 (67.4) |
Variable | Timing of ART | ||
---|---|---|---|
Within 7 days, n (%) | Beyond 7 days, n (%) |
p-value | |
Sex | 0.055 | ||
Male | 95 (52.8) | 80 (42.8) | |
Female | 85 (47.2) | 107 (57.2) | |
Age group | 0.001* | ||
0–5 | 96 (53.3) | 173 (92.5) | |
6–15 | 76 (42.2) | 7 (3.7) | |
15–18 | 8 (4.4) | 7 (3.7) | |
Adherence on ART | 0.012* | ||
Good adherence (≥3 consecutive clinic visits) | 65 (36.1) | 45 (24.1) | |
Inconsistent adherence | 115 (63.9) | 142 (75.9) | |
Baseline Nutrition status | 0.020* | ||
Normal limits & mild malnutrition | 83 (46.1) | 109 (58.3) | |
Moderate & severe malnutrition | 97 (53.9) | 78 (41.7) | |
Baseline ART regimen | 0.001* | ||
Nevirapine based | 45 (25.0) | 98 (52.4) | |
Efavirenz based | 58 (32.2) | 14 (7.5) | |
Protease Inhibitor based | 73 (40.6) | 62 (33.2) | |
Triple RTI | 4 (2.2) | 13 (7.0) | |
WHO clinical stage | 0.001* | ||
I & II | 52 (28.9) | 84 (44.9) | |
III & IV | 128 (71.1) | 103 (55.1) | |
Treatment outcome | |||
Alive and on treatment | 141 (78.3) | 123 (65.8) | 0.026* |
Dead | 15 (8.3) | 27 (14.4) | |
Lost to follow-up | 6 (3.3) | 16 (8.6) | |
Transferred out | 10 (10.0) | 21 (11.2) |
Treatment outcomes
Survival experiences
Variable | N | Number of events | Person years per 1000 | Rate of undetectable VL (95% CI) | 95% CI | HR | 95% CI |
P – value |
---|---|---|---|---|---|---|---|---|
Age group | ||||||||
0–5 (ref) | 269 | 105 | 4.72 | 22.27 | 18.39–26.96 | |||
6–15 | 83 | 31 | 1.07 | 29.03 | 20.42–41.28 | 1.35 | 0.90–2.01 | 0.144 |
15–18 | 15 | 9 | 0.20 | 45.43 | 23.64–87.32 | 2.32 | 1.17–4.60 | 0.016* |
CD4 count (cells/μl) | ||||||||
< 500 (ref) | 109 | 35 | 1.43 | 24.40 | 17.52–33.99 | |||
> = 500 | 258 | 110 | 4.54 | 24.19 | 20.07–29.16 | 0.93 | 0.63–1.35 | 0.688 |
Timing | ||||||||
Beyond 7 days (ref) | 187 | 75 | 3.77 | 19.90 | 15.87–24.95 | |||
Within 7 days | 180 | 70 | 2.21 | 31.64 | 25.03–39.99 | 1.88 | 1.35–2.62 | 0.001* |
Predictors of undetectable viral load
Variable |
N = 367 | % | Unadj. HR | 95% CI | SHRa
| 95% CI |
P
| |
---|---|---|---|---|---|---|---|---|
Age category | 0–5 | 269 | 73.30 | 1.0 (ref) | ||||
6–15 | 83 | 22.62 | 1.34 | 0.90–2.03 | 0.49 | 0.17–1.38 | 0.174 | |
15–18 | 15 | 4.09 | 2.32 | 0.84–6.40 | 0.37 | 0.06–2.15 | 0.270 | |
ART initiation | Beyond 7 days after enrolment | 187 | 50.95 | 1.0 (ref) | ||||
Within 7 days after enrolment | 180 | 49.05 | 1.88 | 1.35–2.62 | 2.02 | 1.24–3.28 | 0.005* | |
Baseline CD4 count (cells/ μl) | <500 | 109 | 29.70 | 1.0 (ref) | ||||
> = 500 | 258 | 70.30 | 0.92 | 0.62–1.38 | 1.36 | 0.80–2.32 | 0.252 | |
Adherence to ART | Good adherence on > = 3 consecutive visits | 110 | 29.97 | 1.0 (ref) | ||||
Inconsistent adherence | 257 | 70.03 | 0.67 | 0.48–0.93 | 0.44 | 0.28–0.67 | 0.001* | |
ART regimen | NVP based | 143 | 38.96 | 1.0 (ref) | ||||
EFV based | 72 | 19.62 | 2.03 | 1.17–3.51 | 1.33 | 0.68–2.60 | 0.407 | |
PI based | 135 | 36.78 | 1.38 | 0.97–1.96 | 1.31 | 0.87–1.98 | 0.201 | |
Triple RTI regimen | 17 | 4.63 | 0.51 | 0.18–1.46 | 0.39 | 0.09–1.63 | 0.196 | |
Baseline Viral load (copies/ml) | >100,000 | 265 | 72.21 | 1.0 (ref) | ||||
<100,000 | 102 | 27.79 | 1.44 | 1.03–2.03 | 0.84 | 0.55–1.27 | 0.411 | |
Baseline WHO stage | Stage III or IV | 231 | 62.94 | 1.0 (ref) | ||||
Stage I or II | 136 | 37.06 | 1.55 | 1.11–2.18 | 1.59 | 1.06–2.28 | 0.024* | |
Baseline weight | 1.02 | 1.01–1.03 | 1.04 | 1.01–1.07 | 0.019* |