Socio-demographic characteristics
A total of 392 randomly selected patients’ charts were reviewed with structured check list and eight were found to be incomplete. Out of the final 384 records that were fully reviewed, 128 patients (33.3%) were enrolled in the UTT program. Nearly two-third (68.7%) of the patients enrolled into the study were females and 214 (55.7%) were urban residents. Half (51%) of the clients were married and more than one third (37%) of patients has no formal education. Regarding their occupational status, 30% of them were unemployed. The mean age at the time of diagnosis was 34.8 years (SD=9.1) with no significant difference between the two programs (Table 1).
Table 1: socio-demographic characteristics of HIV infected patients enrolled in UTT and differed programs in Gurage Zone, 2019.
Variables
|
Outcome by Program
|
|
UTT (N, %)
|
CD4 based (N, %)
|
Total
|
|
TB
|
NO TB
|
TB
|
NO TB
|
(N, %)
|
Mean age at DX
|
34.7+ 8.8
|
|
35.1+ 9.2
|
|
34.8+ 9.1
|
Sex
|
|
|
|
|
|
Male
|
2 (33.3)
|
47(38.5)
|
12 (36.4)
|
59 (26.5)
|
120 (31.2)
|
Female
|
4 (66.7)
|
75 (61.5)
|
21 (63.6)
|
164 (73.5)
|
264 (68.7)
|
Residence
|
|
|
|
|
|
Rural
|
4 (66.7)
|
38 (31)
|
22 (66.6)
|
106(47.5)
|
170 (44.3)
|
Urban
|
2 (33.3)
|
84(69)
|
11 (33.4)
|
117(52.5)
|
214 (55.7)
|
Marital status
|
|
|
|
|
|
Single
|
1 (16.7)
|
17(14)
|
5 (15)
|
40(18)
|
63 (16.4)
|
Married
|
2 (33.3)
|
69(56.5)
|
21 (63.6)
|
104(46.6)
|
196 (51)
|
Divorced
|
3 (50)
|
36(29.5)
|
7 (21.4)
|
79(35.4)
|
125 (32.6)
|
Educational status
|
|
|
|
|
|
Illiterate
|
4 (66.7)
|
44(36)
|
12 (36.4)
|
82(36.8)
|
142 (37)
|
Literate
|
2 (33.3)
|
78(64)
|
21 (63.6)
|
141(63.2)
|
242 (63)
|
Employment status
|
|
|
|
|
|
Employed
|
3 (50)
|
92(75.4)
|
18 (54.5)
|
156(70)
|
269 (70)
|
Unemployed
|
3 (50)
|
30(24.6)
|
15 (45.5)
|
67(30)
|
115 (30)
|
UTT-Universal test and treat DX-Diagnosis TB-Tuberculosis
Baseline and clinical characteristics
The median time from diagnosis to initiation of treatment was 0.7 years (IQR=0.2-1.2). The average weight of participants was 52.3 kg (SD=11.3kg) and; patients in the UTT program had a slightly higher weight (52.5+ 2 Kg) than patients in the differed program (51 + 9 kg). The median CD4 count up on initiation of ART was 201 (IQR: 126-303), which was higher among patients in the UTT program 262.4 (IQR: 130-568) than the differed treatment (181, IQR: 110-235) (Table 2).
During the initiation of ART 51.7% of the patients were in WHO clinical stage III and IV in both groups. In the UTT program, only 39.8% of patients were in WHO clinical stage III and IV, whereas in the deferred treatment program nearly 57.4% of patients were in WHO clinical stage III and IV. More than two-third of patients received IPT (isoniazid preventive therapy- a prophylaxis which is given to prevent active TB). Half of the patients were diagnosed to have at least one opportunistic infection before ART initiation. 5.2% of patients developed treatment failure in the course of ART treatment (Table 2).
Table 2: Baseline clinical characteristics of HIV infected patients enrolled in UTT and differed programs in Gurage Zone, 2019.
Variables
|
Outcome by Program
|
|
UTT (N, %)
|
CD4 based (N, %)
|
Total
|
|
TB
|
NO TB
|
TB
|
NO TB
|
(N, %)
|
WHO Stage
|
|
|
|
|
|
Stage I
|
0 (0)
|
38(31.1)
|
3 (9.1)
|
48(21.5)
|
89 (23.1)
|
Stage II
|
1 (16.7)
|
38(31.1)
|
5 (15.3)
|
53(23.8)
|
97 (25.2)
|
Stage III
|
3 (50)
|
40(32.8)
|
22 (66.7)
|
115(51.5)
|
180 (47)
|
Stage IV
|
2 (33.3)
|
6(4.9)
|
3 (9)
|
7(3.2)
|
18 (4.7)
|
Median CD4 count
|
262.4 (IQR: 130-568)
|
181 (IQR: 110-235)
|
201 (IQR: 126-303)
|
Mean weight
|
52.5+ 2
|
51 + 9
|
52.3+ 11.3
|
Median time to Rx
|
0.3 (IQR=0.1-4.2)
|
0.9 (IQR=0.6-1.6)
|
0.7 (IQR=0.2-1.2)
|
OIS before ART
|
|
|
|
|
|
Yes
|
3 (50)
|
49(40.2)
|
22 (66.7)
|
116(52)
|
190 (49.5)
|
No
|
3 (50)
|
73(59.8)
|
11 (33.3)
|
107(48)
|
194 (50.5)
|
IPT
|
|
|
|
|
|
Yes
|
4(66.7)
|
113(92.6)
|
11(33.3)
|
155(69.5)
|
283(73.7)
|
No
|
2(33.3)
|
9(7.4)
|
22(66.7)
|
68(30.5)
|
101(26.3)
|
Treatment Failure
|
|
|
|
|
|
Yes
|
3 (50)
|
9(7.4)
|
2 (6)
|
6(2.7)
|
20 (5.2)
|
No
|
3 (50)
|
113(92.6)
|
31 (94)
|
217(97.3)
|
364 (94.8)
|
IPT-Isoniazid preventive therapy RX-Treatment
Incidence rate of TB
Among the 384 HIV-infected patients who were followed for a total of 9766 person-month, 39 incident TB cases were identified, making the overall incidence of TB 4.79/100 PY. The overall incidence density rate (IDR) of TB was significantly different for the two comparison groups. The incidence was 2.10/100 PY in the UTT and 6.23/100 PY in the differed treatment program with a p.value of 0.003. After adjusting for the effect of other variables the adjusted incidence rate Ratio (AIRR) of TB among patients enrolled in the UTT program compared to patients enrolled in the differed program was; 0.25(0.08-0.70). Thus, the UTT program reduced TB incidence by 75% compared to the differed treatment program (Table 3).
Also, the incidence differed in different subgroups. Males have a TB incidence of 5.36/100-person-year compared to 4.52/100-person-year incidence among females. Rural residents have a far greater risk of developing TB with, 7.6/100-PY than urban residents which is 2.75/100-person-year. Also, the incidence of TB was higher for unemployed patients, advanced clinical stage patients, and patients that have experienced treatment failure (Table 3).
Table 3: Univariate and multivariate analysis of Incidence rate of TB among clients enrolled in UTT and differed programs in Gurage Zone, 2019
Predictors
|
Event/p-M
|
IR/100P-Y
|
CIRR(95%CI)
|
p.value
|
AIRR(95%CI)
|
Over all
|
39/9766
|
4.79
|
-
|
-
|
-
|
Program
|
|
|
|
|
|
UTT
|
6/ 3417
|
2.10
|
0.33(0.11-0.81)
|
0.003
|
0.25(0.08-0.70)*
|
Differed
|
33/6349
|
6.23
|
1
|
|
1
|
Age
|
-
|
|
-
|
1.01(0.97- 1.04)
|
0.622
|
-
|
Sex
|
|
|
|
|
|
|
Male
|
14/3134
|
|
5.36
|
1.18(0.56- 2.37)
|
0.230
|
1.33(0.64-2.75)
|
Female
|
25/6632
|
|
4.52
|
1
|
|
1
|
Residence
|
|
|
|
|
|
|
Rural
|
26/ 4094
|
|
7.6
|
2.77(1.42-5.38)
|
0.001
|
1.58(0.82- 3.05)
|
Urban
|
13/5672
|
|
2.75
|
1
|
|
|
Employment
|
|
|
|
|
|
|
Employed
|
21/6999
|
|
3.60
|
1
|
|
1
|
Unemployed
|
18/2767
|
|
7.80
|
2.16(1.34-5.10)
|
0.001
|
2.2(0.82-4.54)
|
Marital status
|
|
|
|
|
|
|
Married
|
23/4920
|
|
5.60
|
1.41(0.71- 2.86)
|
0.14
|
1.73(0.88-3.40)
|
Unmarried
|
16/4846
|
|
3.96
|
1
|
|
1
|
Educational status
|
|
|
|
|
|
|
Illiterate
|
16/3680
|
|
5.22
|
1.15(0.56-2.27)
|
0.33
|
|
Literate
|
23/ 6086
|
|
4.53
|
1
|
|
|
Weight
|
-
|
|
-
|
0.97(0.94- 1.00)
|
0.110
|
0.97(0.94- 1.01)
|
WHO Stage
|
|
|
|
|
|
|
Stage I/II
|
9/3600
|
|
3.00
|
0.51(0.26-0.96)
|
0.018
|
0.70(0.61-0.94)*
|
Stage III/IV
|
30/6166
|
|
5.84
|
1
|
|
1
|
IPT
|
|
|
|
|
|
|
Yes
|
15/6800
|
|
2.64
|
0.27(0.18-0.56)
|
0.001
|
0.35(0.22-0.48)*
|
No
|
24/2966
|
|
9.71
|
1
|
|
1
|
Treatment Failure
|
|
|
|
|
|
|
Yes
|
5/ 422
|
|
14.2
|
3.25(1.10-8.36)
|
0.015
|
5.80(1.93-8.46)*
|
No
|
34/ 9344
|
|
4.37
|
1
|
|
1
|
Base line CD4 count
|
-
|
|
-
|
0.99(0.98-1.00)
|
0.050
|
0.96(.94-0.99)*
|
*AIRR-Adjusted Incidence Rate Ratio *IRR-Incidence Rate Ratio *CIRR-Crude Incidence Rate Ratio
Factors associated with TB incidence among HIV infected patients
Through a bivariate analysis, program of enrolment, residence, employment status, marital status, sex, base line weight, history of IPT, base line CD4 count and treatment failure were associated with TB incidence (p.value less than 0.25). A multivariate analysis was conducted on the above variables. After controlling for the effect of other variables program of enrolment, WHO clinical stage, IPT, treatment failure and base line CD4 count were significantly associated with TB incidence among HIV/AIDS infected patients in the course of treatment (Table 3).
After controlling for the effect of other variables, patients enrolled in the UTT program were 75% less likely to develop TB than patients enrolled in the differed program with, AIRR=0.25 (95 % CI [0.08-0.70], p.value <0.001). Additionally, patients who were in WHO clinical stage one and two were 30% less likely to develop TB than patients in clinical stage three and four with; AIRR=0.70 (95 % CI [0.61-0.94], p.value <0.001). Meanwhile, having IPT reduces the risk of developing TB by two-thirds; AIRR=0.35 (95 % CI [0.22-0.48], p.value <0.001). The Risk of developing TB was 5.80 (95 % CI [1.93-8.46], p.value <0.001) times higher for patients who have treatment failure than those that didn’t have failure history. An increase of base-line CD4 count by one unit reduced the risk of developing TB by four percent (Table 3).