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. Author manuscript; available in PMC: 2024 Nov 1.
Published in final edited form as: Curr Opin HIV AIDS. 2023 Sep 11;18(6):349–356. doi: 10.1097/COH.0000000000000818

Table 1.

Comparison of observed and counterfactual placebo-group HIV incidence rates in the AMP studies, HVTN 703/HPTN 081 and HVTN 704/HPTN 085.

Trial Subset Observed placebo HIV incidence (95% CI) Placebo HIV incidence accounting for PrEP (95% CI) Historical data-based counterfactual placebo HIV incidence (95% CI) RGC-based counterfactual placebo HIV incidence (95% CI)
HVTN 703/HPTN 081 Overall 3.1% (2.0%, 4.4%) 3.1% (2.0%, 4.2%) 4.0% (3.7%, 4.3%) --
South Africa 3.2% (1.8%, 5.1%) 3.3% (1.8%, 5.1%) 4.6% (4.2%, 4.9%) --
HVTN 704/HPTN 085 Overall 2.9% (2.1%, 4.0%) 3.9% (2.6%, 5.5%) 3.1% (2.6%, 3.5%) 4.5% (3.5%, 5.8%)
United Stated 1.2% (0.5%, 2.3%) 2.2% (0.7%, 4.2%) 2.3% (1.7%, 2.9%) 4.4% (3.5%, 5.7%)
Peru 5.2% (3.4%, 7.6%) 5.4% (3.4%, 7.7%) 3.0% (2.3%, 3.7%) 4.6% (3.5%, 6.0%)

PrEP=pre-exposure prophylaxis

RGC=rectal gonorrhea

AMP= antibody mediated prevention

HVTN 703/HPTN 081 (ClinicalTrials.gov #NCT02568215)

HVTN 704/HPTN 085 (ClinicalTrials.gov #NCT02716675)