Follow-up Algorithm (visit = FUP)

Figure: Follow-up algorithm



ECR Criteria HIV-1 RNA Criteria HIV-1 DNA Criteria Pass Proposed Algorithm Result Summary
Non-reactive x 1 Not detected Not detected 1

Blinded: No evidence of infection with HIV-1.

Unblinded Report: No evidence of infection with HIV-1.

If any previous HVTN HIV diagnostic test results showed evidence of vaccine-induced sero-reactivity, it is recommended that HIV diagnostic testing continue through the HVTN until no evidence of sero-reactivity is repeatedly demonstrated.

Reactive x1 Not detected Not detected 1

Blinded: No evidence of infection with HIV-1.

Unblinded: No evidence of infection with HIV-1. These results may be due to vaccine-induced sero-reactivity (VISR) or non-specific cross-reactivity.

Reactive x1 Not detected Positive 1

Blinded or Unblinded: HIV-1 Infected based on FUP and SRV or CFM lab results.

Reactive x1 Positive Positive 1

Blinded or Unblinded: HIV-1 Infected based on FUP and SRV or CFM lab results.