Race |
|
|
0.42 |
|
|
0.22 |
0.28 |
Black |
99.0 |
98.8 |
|
100.0 |
98.7 |
|
|
Other |
1.0 |
1.2 |
|
0 |
1.3 |
|
|
|
Study site |
|
|
0.31 |
|
|
<0.001 |
<0.001 |
Soweto |
40.6 |
40.2 |
|
47.5 |
31.5 |
|
|
Cape Town |
25.7 |
29.0 |
|
4.3 |
20.5 |
|
|
KOSH |
26.7 |
19.3 |
|
37.4 |
29.8 |
|
|
CAPRISA |
5.9 |
7.0 |
|
4.3 |
7.6 |
|
|
Medunsa |
1.0 |
4.6 |
|
6.5 |
10.6 |
|
|
|
Adenovirus 5 titer |
|
|
0.15 |
|
|
0.64 |
0.56 |
<200 |
37.6 |
46.0 |
|
46.8 |
44.4 |
|
|
>200 |
63.4 |
54.0 |
|
53.2 |
55.6 |
|
|
|
Risk behaviors in previous 6 months: |
|
|
|
|
|
|
|
Number of sexual partners (MEAN) |
1.3 |
1.1 |
0.001 |
2.5 |
2.2 |
0.21 |
0.05 |
Unprotected vaginal sex (YES VS. NO) |
50.5 |
57.1 |
0.25 |
45.7 |
63.5 |
<0.001 |
<0.001 |
Drinking or drugs with sex (YES VS. NO) |
13.9 |
10.0 |
0.30 |
35.3 |
41.4 |
0.22 |
0.58 |
Casual or anonymous partner (YES VS. NO) |
13.9 |
10.0 |
0.30 |
48.2 |
47.0 |
0.82 |
0.48 |
Exchanged sex for money or gifts (YES VS. NO) |
1.0 |
1.2 |
0.42 |
7.2 |
4.6 |
0.27 |
0.33 |
Sexually transmitted infection (self report) (YES VS. NO) |
3.0 |
6.2 |
0.11 |
2.9 |
7.6 |
0.03 |
0.02 |
Heavy drinking (>5 drinks/day) (MEAN NUMBER OF DAYS) |
1.4 |
1.4 |
0.99 |
6.5 |
7.0 |
0.71 |
0.71 |
|
Believe vaccine is: |
|
|
0.86 |
|
|
0.87 |
0.97 |
Very effective |
5.9 |
5.0 |
|
7.2 |
7.0 |
|
|
Somewhat effective |
19.8 |
17.8 |
|
19.4 |
22.9 |
|
|
Not effective |
2.0 |
1.5 |
|
2.2 |
2.0 |
|
|
I don't know |
72.3 |
75.7 |
|
71.2 |
68.2 |
|
|
|
Prior to unblinding, I think I received: |
|
|
0.97 |
|
|
0.07 |
0.28 |
Vaccine |
31.5 |
32.9 |
|
51.6 |
42.2 |
|
|
Placebo |
19.1 |
19.0 |
|
20.5 |
17.5 |
|
|
I don't know |
49.4 |
48.2 |
|
27.9 |
40.2 |
|
|
|
Participation in trial had beneficial impact on life |
69.0 |
67.7 |
0.92 |
83.8 |
72.7 |
0.04 |
0.14 |
|
Social harm from study involvement: |
|
|
0.50 |
|
|
0.22 |
0.20 |
Minimal disturbance |
5.0 |
8.4 |
|
0.7 |
3.1 |
|
|
Moderate/Major disturbance |
2.0 |
1.2 |
|
0.7 |
2.0 |
|
|
|
Loss to follow-up during study |
21.2 |
19.8 |
0.76 |
22.6 |
28.3 |
0.21 |
0.43 |
|
Adverse event: |
|
|
|
|
|
|
|
Related to study product |
1.0 |
8.5 |
0.004 |
7.9 |
7.3 |
0.82 |
0.14 |