TABLE 1.

Summary of analyses examining the effect of vaginal microbiota on PrEP efficacy in HIV-uninfected women

Study	Site	N	PrEP agent	PrEP adherence	Measurement of vaginal dysbiosis	Overall PrEP efficacy	Efficacy among women with vaginal dysbiosis
CAPRISA-004 (13)	South Africa	688	1% TFV gel	60% of the sample had >50% gel adherence, measured by monthly empty gel applicator returns	Mass spectrometry to identify bacterial proteins at baseline Classified women as Lactobacillus-abundant or non-Lactobacillus-abundant	39% (95% CI: 6–60%)	18% (95% CI: −77–63%) among women with non-Lactobacillus-abundant microbiota 61% (95% CI: 11–84%) among women with Lactobacillus-abundant microbiota
Partners PrEP Study (31)	Kenya, Uganda	1470	Oral FTC/TDF or TDF alone	82% adherence, measured by detection of tenofovir in plasma in a random sample of participants	Gram stain microscopy to characterize women with BV (Nugent score 7–10), intermediate microbiota (score 4–6), and normal microbiota (score 0–3) at baseline and annual follow-up visits	70.5% (95% CI: 45.5–84.0%)	73% (95% CI: 6–92%) efficacy for women with BV 63% (95% CI: −67–92%) efficacy for women with intermediate microbiota 77% (95% CI: 43–90%) efficacy for women with normal microbiota

BV= bacterial vaginosis; TFV= tenofovir; FTC= emtricitabine; TDF= tenofovir disoproxil fumarate; 95% CI= 95% Confidence Interval