Table 3.
Adjusted logistic regression analyses for adverse events and loss-to-follow-up among the 801 participants enrolled in HVTN 503/Phambili, 2007.a
| INDEPENDENT VARIABLE | ADVERSE EVENTS | LOSS-TO-FOLLOW-UP | ||
|---|---|---|---|---|
| OR (95% CI) | p-value | OR (95% CI) | p-value | |
| Age and gender | ||||
| 18-20 year-old females | 0.1 (0.01-0.80) | 0.03 | 0.7 (0.39-1.25) | 0.23 |
| 18-20 year-old males | 1.3 (0.58-2.83) | 0.54 | 0.8 (0.51-1.41) | 0.52 |
| 21-35 year-old females | 1.0 (0.52-1.85) | 0.95 | 0.7 (0.44-1.03) | 0.07 |
| 21-35 year-old males (reference) | 1.0 | 1.0 | ||
| Adenovirus 5 titer | ||||
| > 200 | 1.6 (0.87-2.77) | 0.14 | 0.9 (0.60-1.21) | 0.36 |
| ≤ 200 (reference) | 1.0 | 1.0 | ||
| Risk behaviors in previous 6 months | ||||
| Mean number of sexual partners | 1.1 (0.88-1.27) | 0.54 | 1.0 (0.85-1.08) | 0.50 |
| Unprotected vaginal sex (yes vs. no) | 1.0 (0.58-1.85) | 0.90 | 0.9 (0.60-1.21) | 0.37 |
| Exchanged sex for money or gifts (yes vs. no) | 0.5 (0.13-1.86) | 0.29 | 0.5 (0.19-1.13) | 0.09 |
| Sexually transmitted infection (self-report; yes vs. no) | 1.6 (0.46-5.54) | 0.47 | 0.8 (0.36-1.84) | 0.62 |
| Mean number of days with heavy drinking (>5 drinks/day) | 1.0 (0.97-1.03) | 0.84 | 1.0 (0.96-1.01) | 0.14 |
| Prior to unblinding, I think I received: | ||||
| Vaccine | 1.0 (0.41-2.39) | 0.98 | 1.5 (0.80-2.88) | 0.20 |
| I don't know | 1.1 (0.45-2.57) | 0.87 | 1.3 (0.68-2.47) | 0.43 |
| Placebo (reference) | 1.0 | 1.0 | ||
| Social Harms | ||||
| Minimal disturbance | 0.9 (0.27-3.34) | 0.93 | 1.1 (0.44-3.00) | 0.78 |
| Moderate or major disturbance | 1.4 (0.17-11.72) | 0.75 | 1.4 (0.36-5.56) | 0.63 |
| No social harms reported (reference) | 1.0 | 1.0 | ||
| Reasons for enrolling in vaccine trialb | ||||
| To find a vaccine that works | 0.8 (0.46-1.37) | 0.40 | 1.2 (0.88-1.69) | 0.23 |
| To help community | 1.3 (0.88-1.90) | 0.20 | 0.9 (0.70-1.23) | 0.61 |
| Free HIV tests | 1.5 (0.77-2.90) | 0.24 | 1.7 (1.20-2.32) | 0.002 |
| To be informed about HIV research | 1.3 (0.85-2.00) | 0.23 | 1.1 (0.81-1.44) | 0.60 |
| Free counseling | 0.7 (0.43-0.99) | 0.05 | 0.7 (0.52-0.97) | 0.03 |
| Know someone with HIV | 1.1 (0.86-1.36) | 0.52 | 1.0 (0.91-1.18) | 0.62 |
| To receive other tests or medical care | 0.9 (0.51-1.43) | 0.55 | 1.0 (0.76-1.31) | 0.99 |
| To help me to avoid high-risk behavior | 1.0 (0.61-1.58) | 0.94 | 1.1 (0.83-1.42) | 0.55 |
| Vaccine may protect me from HIV | 0.9 (0.70-1.22) | 0.58 | 0.9 (0.74-1.01) | 0.07 |
| To get paid | 0.9 (0.66-1.20) | 0.45 | 1.2 (0.96-1.39) | 0.13 |
a
Adverse event model adjusted for age and gender, study site, and free counseling. Loss to study follow-up model adjusted for age and gender, study site, free HIV tests, and free counseling.
b
Reasons for enrolling in the vaccine trial were scored on a five point Likert scale.