Vaccine Recent Exposure Algorithm (visit = EXP)

Figure: Vaccine Recent Exposure Algorithm

Table 1. EXP Algorithm - Unblinded Report Summary Comments

ECR (EIA/CMIA/Rapid)	HIV-1 RNA	Geenius	HIV-1 TNA (or DNA)	Unblinded EXP result summary text
Non-reactive x1 ECR	Not detected	Not required	Not required	No evidence of infection with HIV-1 or HIV-2.
Non-reactive x1 ECR	Not detected	Any	Not required	No evidence of infection with HIV-1 or HIV-2.
Reactive or Equivocal x1 ECR	Not detected	Not required	Not required	No evidence of infection with HIV-1 or HIV-2. These results may indicate vaccine-induced sero-reactivity, or these results may be due to non-specific serological cross-reactivity. No further testing is required at this time. Vaccine-induced sero-reactivity will be confirmed at the end of the study.
Reactive or Equivocal x1 ECR	Not detected	Any	Not required	No evidence of infection with HIV-1 or HIV-2. These results may indicate vaccine-induced sero-reactivity, or these results may be due to non-specific serological cross-reactivity. No further testing is required at this time. Vaccine-induced sero-reactivity will be confirmed at the end of the study.
Reactive or Equivocal x1 ECR	Detected	Any	Not required	HIV-1 Infected