Table 1: Baseline characteristics of study participants (HIV-infected children) by randomized study arm assignment (N=142)
Characteristic
|
Overall
|
Clinical & Immunologic(N=71)
|
Clinical, Immunologic & Virologic (N=71)
|
P value
|
Study Site: n (%)
|
|
|
|
|
Mulago
|
70(49)
|
35(49)
|
35(49)
|
1.000a
|
Nsambya
|
72(51)
|
36(51)
|
36(51)
|
|
Age in years: Median (IQR)
|
6 (5, 9)
|
6 (5, 8)
|
7 (5, 9)
|
0.269b
|
Sex: n (%)
|
|
|
|
0.865a
|
Female
|
61 (43)
|
31(43)
|
30(42)
|
|
Male
|
81 (57)
|
40(56)
|
41(58)
|
|
WHO Stage: n (%)
|
|
|
|
0.947c
|
1
|
22 (15)
|
12(17)
|
10 (14)
|
|
2
|
57 (40)
|
29(41)
|
28 (39)
|
|
3
|
54 (38)
|
26(37)
|
28(39)
|
|
4
|
9 (6)
|
4 (6)
|
5 (7)
|
|
NVP Exposure: n (%)
|
|
|
|
0.938c
|
Yes
|
53(37)
|
27(38)
|
26(37)
|
|
No
|
76(54)
|
37(52)
|
39(55)
|
|
Unknown
|
13(9)
|
7(10)
|
6(8)
|
|
In utero ART: n (%)
|
|
|
|
0.960c
|
Yes
|
43 (30)
|
21(30)
|
22 (31)
|
|
No
|
82 (58)
|
41(58)
|
41(58)
|
|
Unknown
|
17 (12)
|
9(12)
|
8(11)
|
|
HIV RNA copies/ml: n (%)
|
|
|
|
0.722a
|
≤1000
|
94 (66)
|
46(65)
|
48(68)
|
|
>1000
|
48 (34)
|
25(35)
|
23(32)
|
|
HIV RNA copies/ml: n (%)
|
|
|
|
1.000 a
|
≤400
|
92(65)
|
46(65)
|
46(65)
|
|
>400
|
50(35)
|
25(35)
|
25(35)
|
|
ART Duration in years: Median (IQR)
|
4 (2, 5)
|
3 (2, 4)
|
4 (2, 5)
|
0.225b
|
CD cell count (%):
Median (IQR)
|
32 (26,38)
|
33 (26, 38)
|
32 (27, 38)
|
0.931 b
|
Absolute CD4 cell count:
Median (IQR)
|
1071
(759, 1416)
|
1097
(776, 1537)
|
1032
(721, 1326)
|
0.501 b
|
BMI-for-age Z:
Median (IQR)
|
-0.26
(-0.92, 0.36)
|
-0.21
(-1.06, 0.43)
|
-0.28
(-0.88, 0.29)
|
0.875 b
|
Weight-for-age Z score: Median (IQR)
|
-0.97
(-1.54, -0.25)
|
-0.97
(-1.37, -0.33)
|
-0.99
(-1.63, -0.15)
|
0.933 b
|
Height-for-age Z score:
Median (IQR)
|
-1.07
(-1.92, -0.34)
|
-1.10
(-1.76, -0.28)
|
-1.03
(-1.93, -0.41)
|
0.979 b
|
Missing: %CD4-15; Abs CD4-2
aChi-square test; bWilcoxon Two-Sample test; cFishers-Exact test
Table 2: Prevalence of viral suppression, crude and adjusted odds ratios (with 95%CI) summarizing the relationship between selected risk factors and viral suppression during a 48 week follow-up period among HIV-infected children in Uganda (N=142)
Characteristic
|
Viral suppression by week
|
Crude Odds Ratio
|
Adjusted Odds Ratio
|
|
Baseline
n (%)
|
24 Weeks
n (%)
|
48 Weeks
n (%)
|
OR (95% CI)
|
aOR (95% CI)
|
Monitoring arm
|
|
|
|
|
|
Immunologic
|
46 (65)
|
43 (68)
|
46 (70)
|
Ref
|
Ref a
|
Immunologic & Virologic
|
46 (65)
|
43 (65)
|
47 (69)
|
0.88 (0.46; 1.69)
|
1.06 (0.47; 2.42)
|
ARV Change∫
|
|
|
|
|
|
No
|
|
78(66)
|
77(69)
|
Ref
|
Ref
|
Yes
|
|
8(80)
|
16(70)
|
1.52 (0.59; 3.89)
|
0.85 (0.27; 2.73)
|
Study Site
|
|
|
|
|
|
Mulago
|
43 (61)
|
38 (59)
|
43 (63)
|
Ref
|
Ref b
|
Nsambya
|
49 (68)
|
48 (74)
|
50 (76)
|
1.56 (0.82; 2.99)
|
0.70 (0.25; 1.96)
|
Sex
|
|
|
|
|
|
Female
|
39(64)
|
34(63)
|
41(69)
|
Ref
|
Ref c
|
Male
|
53(65)
|
52(69)
|
52(69)
|
1.12 (0.58; 2.15)
|
1.01 (0.45; 2.26)
|
WHO Stage
|
|
|
|
|
|
1
|
16(73)
|
12(63)
|
14(66)
|
Ref
|
Ref d
|
2
|
38(67)
|
40(78)
|
40(74)
|
1.14 (0.42; 3.09)
|
0.63 (0.17; 2.26)
|
3
|
33(61)
|
31(61)
|
33(66)
|
0.74 (0.28; 1.98)
|
0.49 (0.14; 1.66)
|
4
|
5(56)
|
3(38)
|
6(67)
|
0.55 (0.13; 2.32)
|
0.28 (0.05; 1.63)
|
NVP Exposure
|
|
|
|
|
|
Yes
|
27(51)
|
28(55)
|
28(56)
|
Ref
|
Ref e
|
No
|
56(74)
|
47(72)
|
55(77)
|
2.61 (1.31; 5.21)**
|
2.75 (1.19; 6.37)**
|
Unknown
|
9(69)
|
11(85)
|
10(77)
|
2.92 (0.83; 10.32)
|
|
In utero ART
|
|
|
|
|
|
Yes
|
27(63)
|
25(60)
|
24(57)
|
Ref
|
Ref f
|
No
|
51(62)
|
47(65)
|
54(72)
|
1.37 (0.67; 2.77)
|
1.20 (0.53; 2.74)
|
Unknown
|
14(82)
|
24(93)
|
15(88)
|
5.10 (1.26; 20.61)*
|
-
|
Age (years)
|
|
|
|
1.01 (0.90; 1.16)
|
1.19 (0.97; 1.48)g
|
ART duration (years)
|
|
|
|
0.70 (0.56; 0.88)**
|
0.67 (0.49; 0.91)h*
|
CD%/cell count
|
|
|
|
1.03 (0.99; 1.07)
|
1.09 (1.04; 1.15)i*
|
Log (Absolute CD4)
|
|
|
|
2.82 (1.39, 5.69)**
|
2.75 (1.17; 15.18)i*
|
BMI-for-age Z:
|
|
|
|
0.79 (0.61; 1.01)
|
0.85 (0.62; 1.15)j
|
Weight-for-age Z:
|
|
|
|
0.96 (0.73; 1.28)
|
1.11 (0.75; 1.64)j
|
Height-for-age Z:
|
|
|
|
1.21 (0.91; 1.61)
|
1.33 (0.91; 1.93)j
|
*p<0.05; **p<0.01
aAdjusted for week, location, sex, age, NVP exposure, In-utero ART, ART duration, Absolute CD4
bAdjusted for study arm, week, sex, age, NVP exposure, In-utero ART, ART duration, Absolute CD4
cAdjusted for study arm, week, Absolute CD4
dAdjusted for study arm, week, location, sex, and in-utero ART
eAdjusted for study arm, week, location, WHO stage, in-utero ART, ART duration and BMI-for-age Z
fAdjusted for study arm, week, and location
gAdjusted for study arm, week, location, sex, NVP exposure, In-utero ART, and BMI-for-age Z
hAdjusted for study arm, week, location, WHO stage, NVP exposure, In-utero ART, and BMI-for-age Z
iAdjusted for study arm, week, location, sex, NVP exposure, In-utero ART, and BMI-for-age Z
jAdjusted for study arm, week, location, sex, NVP exposure, In-utero ART, ART duration and Absolute CD4
∫ARV Change – Time dependent (varying) variable (adjusted for study arm, week, location, NVP exposure, ART duration and baseline absolute CD4 count).
Table 3: Prevalence of ARV change, crude and adjusted odds ratios (with 95%CI) summarizing the relationship between selected risk factors and ARV change during a 48 week follow-up period among HIV-infected children in Uganda (N=142)
Characteristic
|
ARV changed by week
|
Crude Odds Ratio
|
Adjusted Odds Ratio
|
|
12
n (%)
|
24
n (%)
|
36
n (%)
|
48
n (%)
|
OR (95% CI)
|
OR (95% CI)
|
Overall
|
2(1)
|
10(8)
|
12(9)
|
23(17)
|
|
|
Monitoring arm
|
|
|
|
|
|
|
Immunologic
|
-
|
3(5)
|
-
|
9(14)
|
Ref
|
Ref
|
Virologic
|
2(3)
|
7(11)
|
12(18)
|
14(21)
|
1.52 (0.59; 3.89)
|
1.58 (0.62; 4.00) a
|
∫log(HIV RNA copies/ml)
|
|
|
|
|
0.97 (0.90; 1.05)
|
1.02 (0.92; 1.12)a
|
∫Log (ABS CD4)
|
|
|
|
|
0.91 (0.44; 1.86)
|
0.77 (0.29; 2.00)b
|
∫CD4%
|
|
|
|
|
0.99 (0.96; 1.04)
|
0.97 (0.92; 1.04)b
|
Week
|
|
|
|
|
|
|
Baseline
|
|
|
|
|
Ref
|
Ref*
|
24
|
|
|
|
|
1.91 (1.19; 3.07)
|
5.37 (3.02; 7.97) a
|
48
|
|
|
|
|
3.65 (1.40; 9.45)
|
24.10 (9.14; 63.56)a
|
|
|
|
|
|
|
|
*p<0.05; **p<0.01
Participants who had an ARV change are counted in the prevalence estimate at subsequent follow-up
a Covariates in the final adjusted model: log (HIV RNA copies/ml), study arm, week, NVP exposure, ART duration, and location
b Covariates in the final adjusted model: study arm, week, NVP exposure, ART duration, and location
∫Time dependent variable