Table 2.

Change in Vaginal Microbiota Prevalence and Concentration Following Ring Use in Adolescent Females ^a

Organism	Dapivirine Vaginal Ring-004 (n = 70)	P Value DPV vs Baseline	Placebo Ring (n = 23)	P Value PL vs Baseline	P Value PL vs DPV
BV prevalenceb	0.94 (.66–1.24)	.73	0.63 (.36–1.11)	.11	.21
Nugent scorec	–0.12 (–.77 to .53)	.72	–0.79 (–1.49 to –.09)	.03	.12
Lactobacillus crispatus
Prevalenceb	1.27 (1.02–1.58)	.03	1.37 (1.04–1.81)	.03	.63
Quantityc	0.43 (–.05 to .91)	.08	0.69 (–.06 to 1.44)	.07	.56
Lactobacillus iners
Prevalenceb	1.04 (0.96–1.12)	.37	1.04 (.94–1.14)	.44	.96
Quantityc	–0.11 (–.56 to .34)	.63	–0.12 (–.67 to .43)	.67	.97
Lactobacillus jensenii
Prevalenceb	0.98 (.83–1.15)	.82	0.89 (.62–1.26)	.50	.60
Quantityc	––0.07 (–.47 to .33)	.72	–0.15 (–.84 to .54)	.68	.85
Lactobacillus gasseri
Prevalenceb	1.22 (1.00–1.50)	.051	1.27 (1.00–1.63)	.055	.78
Quantityc	0.36 (–.02 to .73)	.06	0.46 (–.03 to .96)	.07	.72
Limosilactobacillus vaginalis
Prevalenceb	1.11 (.88–1.40)	.36	1.35 (.97–1.88)	.07	.27
Quantityc	0.25 (–.24 to .74)	.32	0.59 (–.26 to 1.44)	.17	.46
Gardnerella vaginalis
Prevalenceb	1.02 (.91–1.13)	.78	1.02 (.83–1.26)	.86	.97
Quantityc	–0.30 (–.82 to .23)	.27	–0.29 (–1.13 to .55)	.50	.99
Atopobium vaginae
Prevalenceb	0.84 (.67–1.06)	.14	0.85 (.58–1.23)	.39	.98
Quantityc	–0.58 (–1.19 to .03)	.06	–0.69 (–1.62 to .24)	.15	.84
Megasphaera lornae
Prevalenceb	0.74 (.55–1.00)	.053	0.52 (.29–.93)	.03	.28
Quantityc	–0.53 (–.88 to –.19)	.002	–0.70 (–1.25 to –.14)	.01	.55
Prevotella bivia
Prevalenceb	1.16 (.90–1.51)	.25	0.82 (.56–1.19)	.29	.050
Quantityc	0.23 (–.15 to .60)	.24	–0.27 (–.70 to .16)	.23	.02
Prevotella amnii
Prevalenceb	0.88 (.58–1.33)	.53	0.95 (.51–1.76)	.87	.83
Quantityc	–0.33 (–.83 to .17)	.20	–0.17 (–.96 to .61)	.67	.70
Prevotella timonensis
Prevalenceb	1.20 (1.04–1.38)	.01	0.87 (.66–1.15)	.32	.02
Quantityc	0.52 (.07–.97)	.02	–0.38 (–1.13 to .36)	.32	.02
Enterococcus
Prevalenceb	0.99 (.73–1.34)	.96	0.90 (.54–1.50)	.69	.70
Quantityc	–0.10 (–.52 to .32)	.63	–0.28 (–.87 to .31)	.35	.53
Group B Streptococcus
Prevalenceb	1.16 (.74–1.84)	.52	0.72 (.30–1.72)	.46	.26
Quantityc	0.12 (–.33 to .57)	.60	–0.44 (–1.12 to .24)	.20	.10
Staphylococcus aureus
Prevalenceb	0.85 (.39–1.88)	.69	0.61 (.16–2.24)	.45	.64
Quantityc	–0.01 (–.27 to .26)	.96	–0.04 (–.41 to .32)	.82	.86
Escherichia coli
Prevalenceb	1.15 (.70–1.88)	.58	0.97 (.53–1.79)	.93	.62
Quantityc	–0.29 (–.84 to .26)	.30	–0.43 (–1.00 to .14)	.14	.61
Candida albicans
Prevalenceb	1.05 (.80–1.39)	.71	1.12 (.72–1.76)	.62	.80
Quantityc	0.18 (–.12 to .48)	.24	0.20 (–.36 to .75)	.48	.96
Other yeasts
Prevalenceb	d		d
Quantityc	0.17 (0–.38)	.051	0.21 (–.02– to .43)	.07	.79

Sample sizes are 70 and 23 for DPV and placebo rings for qPCR samples, respectively. Bold values indicate statistical significance in either prevalence and/or quantity from baseline through ring use.

Abbreviations: BV, bacterial vaginosis; DPV, dapivirine vaginal ring-004; PL, placebo ring.

Microbiota prevalence and concentration evaluated at baseline and at 4, 12, and 24 weeks following ring use.

Change in prevalence expressed as relative risk (95% confidence interval [CI]); values <1.0 reflect a decrease, whereas values >1.0 reflect an increase; P value from modified Poisson regression model.

Change in Nugent score and log₁₀ quantity expressed as mean (95% CI); values <0 reflect a decrease, whereas values >0 reflect an increase; P value from mixed-effects linear regression model.

Unable to provide estimates as model did not achieve convergence; 3 participants in each group were colonized by other yeasts at one follow-up visit and one participant in the DPV group was colonized by other yeasts at 2 follow-up visits.