Table 1.
Participant demographic and sexual health characteristics by treatment group, Kisumu, Kenya, 2019.
| Characteristics | Treatment group | |||
|---|---|---|---|---|
| TFV/LNG IVR (n = 11) |
TFV-only IVR (n = 11) |
Placebo IVR (n = 5) |
Overall (n = 27) |
|
| Age, mean (SD)a | 22.09 (2.88) | 25.91 (5.74) | 23.80 (4.76) | 23.96 (4.74) |
| BMI, mean (SD)b | 21.83 (3.78) | 23.38 (3.10) | 23.03 (3.45) | 22.69 (3.40) |
| Menstrual cycle lengtha,c, mean (SD) | 31.14 (4.15) | 29.29 (4.20) | 31.00 (4.54) | 30.42 (4.12) |
| Previously pregnanta | 4 (36.4%) | 6 (54.5%) | 3 (60.0%) | 13 (48.1%) |
| Educationa | ||||
| At least some primary school | 0 (0.0%) | 1 (9.1%) | 2 (40.0%) | 3 (11.1%) |
| At least some secondary school | 9 (81.8%) | 8 (72.7%) | 2 (40.0%) | 19 (70.4%) |
| Completed college/university | 2 (18.2%) | 2 (18.2%) | 1 (20.0%) | 5 (18.5%) |
| Marital status | ||||
| Single | 8 (72.7%) | 7 (63.6%) | 4 (80.0%) | 19 (70.4%) |
| Married | 3 (27.3%) | 3 (27.3%) | 1 (20.0%) | 7 (25.9%) |
| Divorced/separated | 0 (0.0%) | 1 (9.1%) | 0 (0.0%) | 1 (3.7%) |
| Sexually active in past 3 months (n = 20)a | ||||
| Yes | 8 (88.9%) | 7 (100.0%) | 3 (75.0%) | 18 (90.0%) |
| No | 1 (11.1%) | 0 (0.0%) | 1 (25.0%) | 2 (10.0%) |
| Contraceptive use in past 6 monthsa,d | ||||
| None | 1 (9.1%) | 2 (18.2%) | 1 (20.0%) | 4 (14.8%) |
| Oral contraceptives | 2 (18.2%) | 2 (18.2%) | 0 (0.0%) | 4 (14.8%) |
| Male condom | 9 (81.8%) | 8 (72.7%) | 4 (80.0%) | 21 (77.8%) |
| Intrauterine device | 1 (9.1%) | 1 (9.1%) | 0 (0.0%) | 2 (7.4%) |
| Nugent score | ||||
| Nugent score at IVR insertionb, median (IQR) | 0.00 (0.00–5.00) | 0.00 (0.00–0.00) | 0.00 (0.00–7.00) | 0.00 (0.00–5.00) |
| Positive for BVe at screeninga | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Positive for BVe at IVR insertionb | 1 (9.1%) | 1 (9.1%) | 2 (40.0%) | 4 (14.8%) |
TFV, tenofovir; LNG, levonorgestrel; IVR, intravaginal ring; SD, standard deviation; BMI, body mass index; IQR, interquartile range; BV, bacterial vaginosis.
Data collected at screening visit where participants were allowed to skip the question.
Data collected just preceding (at time of) IVR insertion (baseline, Visit 3).
Menstrual cycle length estimated from dates recorded on a Screening Menstrual Bleeding Electronic Case Report Form. The average of 2 cycles was taken for women who provided 3 dates, otherwise cycle length is computed from 2 dates. Eight women had just one menstrual period start date recorded and therefore are not included in computation of cycle length.
A participant could report more than 1 type of contraception.
Nugent score ≥7 was interpreted as positive for BV. Nugent score assessment occurred at both screening visit and IVR insertion visit (baseline, Visit 3).