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Table 3 Outcomes compared between randomization arms adjusted for baseline CD4 percentage and caregiver antiretroviral drug use

From: Medication diaries do not improve outcomes with highly active antiretroviral therapy in Kenyan children: a randomized clinical trial

Outcome variable

Diary arm

Control

P-value

 

Mean or No*

SD or %**

Mean or No

SD or %**

 

No missed doses 3-day recall (questionnaire)

270*

85**

283*

92**

0.08a

Adherence >95%

35/47

74

38/43

88

0.20

Mortality

9/53

17

7/46

15

0.67

Hospitalization

13/53

25

10/46

22

0.51

Mean CD4 cells/μl

     

6 monthsb

585

92

664

105

0.25

15 monthsb

729

95

689

88

0.83

Mean CD4 percent

     

6 monthsb

17.2

3.4

16.3

1.6

0.92

15 monthsb

17.6

1.6

18.9

2.0

0.36

Mean HIV-1 RNA log10 copies/ml

     

3 months (n = 51)

2.69

1.52

2.43

1.17

0.57

6 months (n = 44)

2.27

1.72

2.14

0.94

0.33

9 months (n = 28)

2.77

1.40

2.40

1.27

0.24

VL <100 copies/ml

     

3 months

9/27

33

6/24

25

0.61

6 months

10/22

45

11/22

50

0.57

9 months

7/14

50

5/14

36

0.83

Mean WAZc

     

3 months (n = 67)

-2.14

0.28

-1.98

0.21

0.99

9 months (n = 62)

-1.36

0.33

-1.55

0.20

0.407

15 months (n = 58)

-1.25

0.23

-1.53

0.25

0.21

Mean HAZc

     

3 months (n = 62)

-2.60

0.26

-2.70

0.24

0.62

9 months (n = 61)

-3.73

1.64

-1.84

0.18

0.79

15 months (n = 57)

-1.76

0.25

-3.62

1.82

0.32

Mean WHZ score(SD)c

     

3 months (n = 55)

-0.29

0.24

-0.68

0.24

0.18

9 months (n = 53)

-0.24

0.30

-0.35

0.25

0.88

15 months (n = 48)

0.21

0.20

-0.18

0.31

0.35

Loss to follow up

12*

23**

6*

13**

0.21

  1. a: GEE (generalized estimating equation) used. b. Data from 20 and 24 children in diary and control respectively c. Numbers for all z-scores month 25 and 28 in diary and control respectively