Per-Sex-Act HIV-1 Relative Risk Reduction Associated With Consistent Dapivirine Ring Use (Estimated Release of 4.5 mg/mo)
| . | Dapivirine Group: HIV-1 Events Per 10 000 Sex Acts (95% CI)a . | Placebo Group: HIV-1 Events Per 10 000 Sex Acts (95% CI) . | Unadjusted Model . | Adjusted Modelb . | Adjusted and Weighted Modelb,c . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Interaction P . | ||
| Overall | 2.3 (1.8–3.1) | 3.6 (2.9–4.4) | 57 (24–75) | .004 | 62 (32–79) | .001 | 63 (33–80) | .001 | … |
| Baseline age | |||||||||
| <25 y (n = 886) | 5.0 (3.5–6.9) | 5.3 (3.9–7.3) | 53 (0–77) | .049 | 61 (16–82) | .016 | 62 (17–82) | .014 | .844 |
| ≥25 y (n = 1488) | 1.1 (.7–1.8) | 2.8 (2.0–3.7) | 47 (−25 to 77) | .148 | 54 (−20 to 82) | .114 | 55 (−16 to 83) | .096 | |
| Baseline STIs/BV | |||||||||
| N. gonorrhoeae not detected (n = 2273) | 2.1 (1.6–2.8) | 3.3 (2.6–4.2) | 56 (19–76) | .009 | 61 (27–79) | .003 | 62 (29–80) | .003 | .683 |
| N. gonorrhoeae detected (n = 101) | 7.2 (2.9–14.9) | 11.0 (5.0–20.8) | 59 (−104 to 92) | .277 | 72 (−67 to 95) | .162 | 72 (−64 to 95) | .159 | |
| C. trachomatis not detected (n = 2101) | 1.9 (1.3–2.6) | 3.2 (2.5–4.1) | 49 (3–73) | .039 | 53 (9–76) | .026 | 54 (10–77) | .023 | .181 |
| C. trachomatis detected (n = 273) | 6.2 (3.5–10.2) | 7.3 (4.2–11.9) | 75 (2–92) | .020 | 81 (37–95) | .007 | 83 (42–95) | .005 | |
| T. vaginalis detected (n = 2211) | 2.1 (1.6–2.9) | 3.5 (2.7–4.3) | 62 (30–80) | .002 | 66 (35–83) | .001 | 68 (38–83) | .001 | .250 |
| T. vaginalis detected (n = 163) | 4.9 (2.1–9.7) | 5.2 (2.2–10.2) | −26 (−621 to 78) | .798 | 16 (−348 to 84) | .839 | 10 (−363 to 83) | .899 | |
| BV not detected (n = 1404) | 2.0 (1.4–2.9) | 2.7 (1.9–3.7) | 51 (−6 to 77) | .071 | 53 (−1 to 78) | .052 | 54 (1 to 78) | .048 | .441 |
| BV detected (n = 970) | 2.8 (1.8–4.1) | 5.0 (3.6–6.7) | 63 (10–84) | .028 | 71 (26–89) | .010 | 72 (28–89) | .008 | |
| Menses/bleeding in past mo | |||||||||
| No | 2.9 (2.0–3.9) | 4.0 (3.0–5.2) | 47 (0–72) | .049 | 55 (12–77) | .020 | 56 (14–78) | .017 | .282 |
| Yes | 1.6 (.9–2.7) | 2.9 (1.9–4.2) | 77 (26–93) | .014 | 78 (28–94) | .013 | 79 (30–94) | .011 | |
| . | Dapivirine Group: HIV-1 Events Per 10 000 Sex Acts (95% CI)a . | Placebo Group: HIV-1 Events Per 10 000 Sex Acts (95% CI) . | Unadjusted Model . | Adjusted Modelb . | Adjusted and Weighted Modelb,c . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Interaction P . | ||
| Overall | 2.3 (1.8–3.1) | 3.6 (2.9–4.4) | 57 (24–75) | .004 | 62 (32–79) | .001 | 63 (33–80) | .001 | … |
| Baseline age | |||||||||
| <25 y (n = 886) | 5.0 (3.5–6.9) | 5.3 (3.9–7.3) | 53 (0–77) | .049 | 61 (16–82) | .016 | 62 (17–82) | .014 | .844 |
| ≥25 y (n = 1488) | 1.1 (.7–1.8) | 2.8 (2.0–3.7) | 47 (−25 to 77) | .148 | 54 (−20 to 82) | .114 | 55 (−16 to 83) | .096 | |
| Baseline STIs/BV | |||||||||
| N. gonorrhoeae not detected (n = 2273) | 2.1 (1.6–2.8) | 3.3 (2.6–4.2) | 56 (19–76) | .009 | 61 (27–79) | .003 | 62 (29–80) | .003 | .683 |
| N. gonorrhoeae detected (n = 101) | 7.2 (2.9–14.9) | 11.0 (5.0–20.8) | 59 (−104 to 92) | .277 | 72 (−67 to 95) | .162 | 72 (−64 to 95) | .159 | |
| C. trachomatis not detected (n = 2101) | 1.9 (1.3–2.6) | 3.2 (2.5–4.1) | 49 (3–73) | .039 | 53 (9–76) | .026 | 54 (10–77) | .023 | .181 |
| C. trachomatis detected (n = 273) | 6.2 (3.5–10.2) | 7.3 (4.2–11.9) | 75 (2–92) | .020 | 81 (37–95) | .007 | 83 (42–95) | .005 | |
| T. vaginalis detected (n = 2211) | 2.1 (1.6–2.9) | 3.5 (2.7–4.3) | 62 (30–80) | .002 | 66 (35–83) | .001 | 68 (38–83) | .001 | .250 |
| T. vaginalis detected (n = 163) | 4.9 (2.1–9.7) | 5.2 (2.2–10.2) | −26 (−621 to 78) | .798 | 16 (−348 to 84) | .839 | 10 (−363 to 83) | .899 | |
| BV not detected (n = 1404) | 2.0 (1.4–2.9) | 2.7 (1.9–3.7) | 51 (−6 to 77) | .071 | 53 (−1 to 78) | .052 | 54 (1 to 78) | .048 | .441 |
| BV detected (n = 970) | 2.8 (1.8–4.1) | 5.0 (3.6–6.7) | 63 (10–84) | .028 | 71 (26–89) | .010 | 72 (28–89) | .008 | |
| Menses/bleeding in past mo | |||||||||
| No | 2.9 (2.0–3.9) | 4.0 (3.0–5.2) | 47 (0–72) | .049 | 55 (12–77) | .020 | 56 (14–78) | .017 | .282 |
| Yes | 1.6 (.9–2.7) | 2.9 (1.9–4.2) | 77 (26–93) | .014 | 78 (28–94) | .013 | 79 (30–94) | .011 | |
All models were stratified by study site. RRR calculated as ( − hazard ratio) × 100.
Abbreviations: BV, bacterial vaginosis; CI, confidence interval; HIV-1, human immunodeficiency virus-1; RRR, relative risk reduction; STI, sexually transmitted infection.
aCrude incidence rates of HIV-1 events per 10 000 sex acts include all participants in the dapivirine ring group. However, the per-sex-act RRR estimates in the table compare the probability of HIV-1 infection between women in the dapivirine ring group with 4.5 mg/month drug release and women in the placebo ring group (for whom dapivirine release rate was 0 mg/month). Hence, comparison of the crude incidence rates will not equate to the unadjusted RRR estimate.
bMultivariable Cox regression models were adjusted for report of any condomless sex and the following baseline variables: age, education, marital status, BV status, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis diagnosis, any new sexual partners, multiple sexual partners, number of sex acts in last 3 months, any condomless sex in last 7 days, alcohol use, partner HIV-1 status and knowledge of ring use, family planning method, and local HIV-1 prevalence for men within the same age group.
cAdjusted using inverse probability of censoring weights to account for selection bias due to participant censoring at first pregnancy, first product hold >3 days, and loss-to-follow-up given likely changes in HIV-1 risk after these events.
Per-Sex-Act HIV-1 Relative Risk Reduction Associated With Consistent Dapivirine Ring Use (Estimated Release of 4.5 mg/mo)
| . | Dapivirine Group: HIV-1 Events Per 10 000 Sex Acts (95% CI)a . | Placebo Group: HIV-1 Events Per 10 000 Sex Acts (95% CI) . | Unadjusted Model . | Adjusted Modelb . | Adjusted and Weighted Modelb,c . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Interaction P . | ||
| Overall | 2.3 (1.8–3.1) | 3.6 (2.9–4.4) | 57 (24–75) | .004 | 62 (32–79) | .001 | 63 (33–80) | .001 | … |
| Baseline age | |||||||||
| <25 y (n = 886) | 5.0 (3.5–6.9) | 5.3 (3.9–7.3) | 53 (0–77) | .049 | 61 (16–82) | .016 | 62 (17–82) | .014 | .844 |
| ≥25 y (n = 1488) | 1.1 (.7–1.8) | 2.8 (2.0–3.7) | 47 (−25 to 77) | .148 | 54 (−20 to 82) | .114 | 55 (−16 to 83) | .096 | |
| Baseline STIs/BV | |||||||||
| N. gonorrhoeae not detected (n = 2273) | 2.1 (1.6–2.8) | 3.3 (2.6–4.2) | 56 (19–76) | .009 | 61 (27–79) | .003 | 62 (29–80) | .003 | .683 |
| N. gonorrhoeae detected (n = 101) | 7.2 (2.9–14.9) | 11.0 (5.0–20.8) | 59 (−104 to 92) | .277 | 72 (−67 to 95) | .162 | 72 (−64 to 95) | .159 | |
| C. trachomatis not detected (n = 2101) | 1.9 (1.3–2.6) | 3.2 (2.5–4.1) | 49 (3–73) | .039 | 53 (9–76) | .026 | 54 (10–77) | .023 | .181 |
| C. trachomatis detected (n = 273) | 6.2 (3.5–10.2) | 7.3 (4.2–11.9) | 75 (2–92) | .020 | 81 (37–95) | .007 | 83 (42–95) | .005 | |
| T. vaginalis detected (n = 2211) | 2.1 (1.6–2.9) | 3.5 (2.7–4.3) | 62 (30–80) | .002 | 66 (35–83) | .001 | 68 (38–83) | .001 | .250 |
| T. vaginalis detected (n = 163) | 4.9 (2.1–9.7) | 5.2 (2.2–10.2) | −26 (−621 to 78) | .798 | 16 (−348 to 84) | .839 | 10 (−363 to 83) | .899 | |
| BV not detected (n = 1404) | 2.0 (1.4–2.9) | 2.7 (1.9–3.7) | 51 (−6 to 77) | .071 | 53 (−1 to 78) | .052 | 54 (1 to 78) | .048 | .441 |
| BV detected (n = 970) | 2.8 (1.8–4.1) | 5.0 (3.6–6.7) | 63 (10–84) | .028 | 71 (26–89) | .010 | 72 (28–89) | .008 | |
| Menses/bleeding in past mo | |||||||||
| No | 2.9 (2.0–3.9) | 4.0 (3.0–5.2) | 47 (0–72) | .049 | 55 (12–77) | .020 | 56 (14–78) | .017 | .282 |
| Yes | 1.6 (.9–2.7) | 2.9 (1.9–4.2) | 77 (26–93) | .014 | 78 (28–94) | .013 | 79 (30–94) | .011 | |
| . | Dapivirine Group: HIV-1 Events Per 10 000 Sex Acts (95% CI)a . | Placebo Group: HIV-1 Events Per 10 000 Sex Acts (95% CI) . | Unadjusted Model . | Adjusted Modelb . | Adjusted and Weighted Modelb,c . | ||||
|---|---|---|---|---|---|---|---|---|---|
| . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Per-Sex-Act RRR, % (95% CI) . | P . | Interaction P . | ||
| Overall | 2.3 (1.8–3.1) | 3.6 (2.9–4.4) | 57 (24–75) | .004 | 62 (32–79) | .001 | 63 (33–80) | .001 | … |
| Baseline age | |||||||||
| <25 y (n = 886) | 5.0 (3.5–6.9) | 5.3 (3.9–7.3) | 53 (0–77) | .049 | 61 (16–82) | .016 | 62 (17–82) | .014 | .844 |
| ≥25 y (n = 1488) | 1.1 (.7–1.8) | 2.8 (2.0–3.7) | 47 (−25 to 77) | .148 | 54 (−20 to 82) | .114 | 55 (−16 to 83) | .096 | |
| Baseline STIs/BV | |||||||||
| N. gonorrhoeae not detected (n = 2273) | 2.1 (1.6–2.8) | 3.3 (2.6–4.2) | 56 (19–76) | .009 | 61 (27–79) | .003 | 62 (29–80) | .003 | .683 |
| N. gonorrhoeae detected (n = 101) | 7.2 (2.9–14.9) | 11.0 (5.0–20.8) | 59 (−104 to 92) | .277 | 72 (−67 to 95) | .162 | 72 (−64 to 95) | .159 | |
| C. trachomatis not detected (n = 2101) | 1.9 (1.3–2.6) | 3.2 (2.5–4.1) | 49 (3–73) | .039 | 53 (9–76) | .026 | 54 (10–77) | .023 | .181 |
| C. trachomatis detected (n = 273) | 6.2 (3.5–10.2) | 7.3 (4.2–11.9) | 75 (2–92) | .020 | 81 (37–95) | .007 | 83 (42–95) | .005 | |
| T. vaginalis detected (n = 2211) | 2.1 (1.6–2.9) | 3.5 (2.7–4.3) | 62 (30–80) | .002 | 66 (35–83) | .001 | 68 (38–83) | .001 | .250 |
| T. vaginalis detected (n = 163) | 4.9 (2.1–9.7) | 5.2 (2.2–10.2) | −26 (−621 to 78) | .798 | 16 (−348 to 84) | .839 | 10 (−363 to 83) | .899 | |
| BV not detected (n = 1404) | 2.0 (1.4–2.9) | 2.7 (1.9–3.7) | 51 (−6 to 77) | .071 | 53 (−1 to 78) | .052 | 54 (1 to 78) | .048 | .441 |
| BV detected (n = 970) | 2.8 (1.8–4.1) | 5.0 (3.6–6.7) | 63 (10–84) | .028 | 71 (26–89) | .010 | 72 (28–89) | .008 | |
| Menses/bleeding in past mo | |||||||||
| No | 2.9 (2.0–3.9) | 4.0 (3.0–5.2) | 47 (0–72) | .049 | 55 (12–77) | .020 | 56 (14–78) | .017 | .282 |
| Yes | 1.6 (.9–2.7) | 2.9 (1.9–4.2) | 77 (26–93) | .014 | 78 (28–94) | .013 | 79 (30–94) | .011 | |
All models were stratified by study site. RRR calculated as ( − hazard ratio) × 100.
Abbreviations: BV, bacterial vaginosis; CI, confidence interval; HIV-1, human immunodeficiency virus-1; RRR, relative risk reduction; STI, sexually transmitted infection.
aCrude incidence rates of HIV-1 events per 10 000 sex acts include all participants in the dapivirine ring group. However, the per-sex-act RRR estimates in the table compare the probability of HIV-1 infection between women in the dapivirine ring group with 4.5 mg/month drug release and women in the placebo ring group (for whom dapivirine release rate was 0 mg/month). Hence, comparison of the crude incidence rates will not equate to the unadjusted RRR estimate.
bMultivariable Cox regression models were adjusted for report of any condomless sex and the following baseline variables: age, education, marital status, BV status, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis diagnosis, any new sexual partners, multiple sexual partners, number of sex acts in last 3 months, any condomless sex in last 7 days, alcohol use, partner HIV-1 status and knowledge of ring use, family planning method, and local HIV-1 prevalence for men within the same age group.
cAdjusted using inverse probability of censoring weights to account for selection bias due to participant censoring at first pregnancy, first product hold >3 days, and loss-to-follow-up given likely changes in HIV-1 risk after these events.
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