Baseline factors | Incidence rate of BV recurrence (per 100 person-months) by exposure level (NR*/person-months) | Unadjusted HR§ with 95% CI¶ | p-value | HR§ (adjusted for study site) with 95% CI¶ | p-value |
---|---|---|---|---|---|
Study sites | |||||
Chennai/ Bagalkot District | 39.5 (142/359.57) | 5.27 (3.90 – 7.12) | <0.0001 | - | - |
Cotonou | 28.9 (160/553.93) | 3.69 (2.76 – 4.94) | <0.0001 | - | - |
Kampala (ref) | 7.9 (69/869.62) | 1.00 - | - | - | - |
Age (years; continuous) | - | 1.03 (1.01 – 1.04) | 0.0004 | 0.99 (0.97 - 1.00) | 0.1452 |
Age (category): | |||||
≥28 years (median) | 25.8 (196/760.83) | 1.52 (1.19 – 1.94) | 0.0009 | 0.83 (0.64 - 1.07) | 0.1476 |
<28 years | 17.1 (175/1022.28) | 1.00 - | - | 1.00 - | - |
Number of years in school (continuous) | - | 0.99 (0.95 – 1.03) | 0.6279 | 1.02 (0.98 - 1.05) | 0.2832 |
Years in school (category): | |||||
≥ 6 years | 16.8 (151/900.52) | 0.67 (0.52 – 0.86) | 0.0015 | 1.05 (0.84 - 1.32) | 0.6427 |
< 6 years | 24.9 (220/882.60) | 1.00 - | - | 1.00 - | - |
Living with a man | |||||
Yes | 31.9 (95/297.70) | 1.75 (1.35 – 2.26) | <0.0001 | 0.99 (0.73 - 1.32) | 0.9227 |
No | 18.6 (276/1485.42) | 1.00 - | - | 1.00 - | - |
Exerting an occupation besides sex work | |||||
Yes | 26.9 (123/457.67) | 1.44 (1.10 - 1.89) | 0.0076 | 0.89 (0.68 - 1.15) | |
No (Ref.) | 18.7 (248/1325.45) | 1.00 - | - | 1.00 - | 0.3612 |
Having ever been pregnant | |||||
Yes | 21.3 (354/1659.72) | 1.55 (0.89 – 2.71) | 0.1201 | 1.16 (0.73 - 1.83) | 0.5249 |
No | 13.8 (17/123.40) | 1.00 - | - | 1.00 - | - |
Current contraceptive method | |||||
Female sterilization | 38.2 (121/316.67) | 2.21 (1.69 – 2.90) | <0.0001 | 0.99 (0.66 - 1.51) | 0.9934 |
Intra-uterine device | 37.9 (4/10.55) | 2.16 (0.90 – 5.15) | 0.0837 | 1.14 (0.56 - 2.34) | 0.7215 |
Injectable | 11.8 (18/152.70) | 0.66 (0.39 - 1.13) | 0.1308 | 1.21 (0.69 - 2.10) | 0.5095 |
Oral | 13.1 (18/137.25) | 0.73 (0.41 - 1.29) | 0.2800 | 0.98 (0.57 - 1.70) | 0.9577 |
None (Ref.) | 18.0 (210/1165.95) | 1.00 - | - | 1.00 - | - |
Recent intra-vaginal cleansing reported at baseline | |||||
Yes | 32.3 (112/347.20) | 1.75 (1.34 - 2.28) | <.0001 | 1.31 (1.03 - 1.66) | 0.0279 |
No | 18.5 (246/1326.27) | 1.00 - | - | 1.00 - | - |
Number of sexual partners /last 7days (Continuous) | - | 0.98 (0.97 - 0.99) | 0.0003 | 0.99 (0.99 - 1.00) | 0.4145 |
Number of sexual partners /last 7 days: | |||||
≥ 8 partners (median) | 14.9 (159/1067.18) | 0.49 (0.39 – 0.63) | <0.0001 | 0.89 (0.67 - 1.18) | 0.4079 |
< 8 partners | 29.6 (212/715.93) | 1.00 - | - | 1.00 - | - |
Having a primary partner | |||||
Yes | 21.6 (289/1337.92) | 1.18 (0.88 – 1.59) | 0.2679 | 0.98 (0.75 - 1.27) | 0.8825 |
No | 18.4 (82/445.20) | 1.00 - | - | - | |
CCU‡ with primary partner in the past 7 days: | |||||
Yes | 17.3 (83/479.37) | 0.68 (0.48 – 0.96) | 0.0277 | 0.77 (0.56 – 1.07) | 0.1236 |
No (ref.) | 28.7 (134/466.28) | 1.00 - | - | 1.00 - | - |
No primary partner or no sexual act with him | 18.4 (154/837.47) | 0.74 (0.55 – 0.99) | 0.0459 | 0.97 (0.74 - 1.28) | 0.8564 |
CCU‡ with other partners in the past 7 days: | |||||
Yes | 20.3 (329/1620.65) | 0.49 (0.19 – 1.28) | 0.1467 | 0.86 (0.34 – 2.18) | 0.7505 |
No (ref.) | 25.1 (19/75.70) | 1.00 - | - | - | - |
No sexual act with other partners | 26.5 (23/86.77) | 0.62 (0.22 – 1.71) | 0.3556 | 0.96 (0.35 – 2.59) | 0.9340 |
History of STI | |||||
Yes | 27.0 (176/651.55) | 1.53 (1.14 - 2.05) | 0.0046 | 1.13 (0.86 - 1.47) | 0.3864 |
No | 17.2 (195/1131.57) | 1.00 - | - | 1.00 - | - |
Anal /oral sex with primary partner/ past 30 days | |||||
Yes | 29.2 (14/47.97) | 1.30 (0.70 - 2.42) | 0.4018 | 0.72 (0.38 - 1.34) | 0.3011 |
No (Ref) | 22.3 (292/1311.10) | 1.00 - | - | 1.00 - | - |
Did not have primary partner | 16.5 (52/314.40) | 0.74 (0.52 - 1.04) | 0.0800 | 0.99 (0.73 - 1.33) | 0.9381 |
Anal /oral sex with primary partner without condom | |||||
Yes | 29.9 (9/30.08) | 1.34 (0.68 - 2.65) | 0.3951 | 0.78 (0.41 - 1.50) | 0.4594 |
No (Ref) | 22.3 (297/1328.98) | 1.00 - | - | 1.00 - | - |
Did not have primary partner | 16.5 (52/314.40) | 0.73 (0.52 - 1.03) | 0.0766 | 1.01 (0.74 - 1.35) | 0.9931 |
Anal /oral sex with other partners/past 30 days | |||||
Yes | 46.4 (28/60.32) | 2.26 (1.60 - 3.18) | <.0001 | 1.20 (0.82 - 1.74) | 0.3434 |
No (Ref) | 20.7 (330/1591.95) | 1.00 - | - | 1.00 - | - |
Anal /oral sex with other partners without condom | |||||
Yes | 47.3 (10/21.15) | 2.19 (1.08 - 4.44) | 0.0298 | 1.17 (0.57 - 2.38) | 0.6671 |
No anal or oral sex with other partners (Ref.) | 21.3 (348/1631.12) | 1.00 - | - | 1.00 - | - |
History of irregular menstrual cycles | |||||
Yes | 22.3 (78/349.37) | 1.09 (0.80 – 1.48) | 0.5733 | 1.11 (0.84 - 1.47) | 0.4708 |
No | 20.4 (293/1433.75) | 1.00 - | - | 1.00 - | - |
Treatment group | |||||
Active gel | 21.5 (178/828.88) | 1.07 (0.84 – 1.38) | 0.5753 | 0.97 (0.77 - 1.21) | 0.7645 |
Placebo | 20.2 (193/954.23) | 1.00 - | - | 1.00 - | - |
Gonorrhea | |||||
Present | 26.3 (31/117.82) | 1.32 (0.81 - 2.12) | 0.2618 | 1.27 (0.81 - 2.00) | 0.30271 |
Absent | 20.3 (336/1650.72) | 1.00 - | - | 1.00 - | - |
Chlamydia | |||||
Present | 13.4 (18/134.65) | 0.63 (0.34 - 1.15) | 0.1319 | 1.07 (0.62 - 1.85) | 0.8035 |
Absent | 21.4 (349/1633.88) | 1.00 - | - | 1.00 - | - |
Trichomoniasis | |||||
Present | 16.4 (14/85.27) | 0.76 (0.35 - 1.62) | 0.4720 | 0.90 (0.50 - 1.62) | 0.7339 |
Absent | 21.2 (357/1686.95) | 1.00 - | - | 1.00 - | - |
Candidiasis | |||||
Present | 21.8 (85/389.47) | 1.05 (0.80 - 1.39) | 0.7130 | 0.97 (0.72 - 1.31) | 0.8678 |
Absent | 20.7 (286/1382.75) | 1.00 - | - | 1.00 - | - |