Table 1.
Baseline Characteristics of Participants in the Preventing Vaginal Infections Trial Who Were Eligible for Secondary Analysis
| Characteristic | Placebo Group (n = 110) | Intervention Group (n = 111) |
|---|---|---|
| Demographic characteristic | ||
| Age, y | ||
| Overall | 29 (23–34) | 30 (24–34) |
| <25 | 29 (26) | 33 (30) |
| Education duration, y | 11 (8–12) | 10 (8–13) |
| Partnership status | ||
| Married or living with a partner | 29 (26) | 34 (31) |
| Separated, divorced, or widowed | 48 (44) | 39 (35) |
| Never married | 33 (30) | 38 (34) |
| Study site | ||
| Birmingham, AL | 26 (24) | 27 (24) |
| Kangemi area, Nairobi, Kenya | 27 (25) | 28 (25) |
| Korogocho area, Nairobi, Kenya | 28 (25) | 28 (25) |
| Mombasa, Kenya | 29 (26) | 28 (25) |
| Health history | ||
| Live births, no. | 2 (1–3) | 2 (1–3) |
| Current family planning method | ||
| None | 16 (15) | 23 (21) |
| Condoms only | 30 (27) | 31 (28) |
| Oral contraceptives | 12 (11) | 11 (10) |
| Injectable contraceptives | 25 (23) | 24 (22) |
| IUD | 10 (9) | 4 (4) |
| Implant | 9 (8) | 5 (5) |
| Tubal ligation | 5 (5) | 10 (9) |
| Othera | 3 (3) | 3 (3) |
| Currently smoke cigarettes | 10 (9) | 20 (18) |
| Vaginal washing in the past month | 55 (50) | 56 (50) |
| Sexual behavior | ||
| Ever engaged in sex in exchange for goods/money/services | 60 (55) | 59 (53) |
| Vaginal sex acts in the past week, no. | 2 (1–4) | 2 (1–3) |
| Condom use during sex in past week | ||
| Always | 53 (48) | 42 (38) |
| Intermittentlyb | 11 (10) | 12 (11) |
| Never | 26 (24) | 36 (32) |
| No sex reported | 20 (18) | 21 (19) |
| Sex partners in past week, no. | 1 (1–2) | 1 (1–2) |
| New sex partner in past week | 23 (21) | 22 (20) |
| Ever had anal sex | 13 (12) | 12 (11) |
| Clinical characteristic | ||
| C. trachomatis infection | 8 (7) | 8 (7) |
| N. gonorrhoeae infection | 0 (0) | 3 (3) |
| M. genitalium infectionc | 9 (8) | 16 (14) |
| HSV-2 seropositived | 68 (62) | 71 (64) |
| T. vaginalis infectionc | 6 (5) | 10 (9) |
| Vulvovaginal candidiasis | 24 (22) | 28 (25) |
| Bacterial vaginosise | 40 (36) | 41 (37) |
| Intermediate microbiotae | 20 (18) | 24 (22) |
| Normal microbiotae | 50 (45) | 46 (41) |
| Cervicitisf | 14 (13) | 18 (16) |
Data are no. (%) of women or median (interquartile range).
Abbreviations: C. trachomatis, Chlamydia trachomatis; HSV-2, herpes simplex virus type 2; IUD, intrauterine device; M. genitalium, Mycoplasma genitalium; N. gonorrhoeae, Neisseria gonorrhoeae.
a Included the fertility awareness method (n = 2), vasectomy by partner (n = 1), Essure use (n = 1), withdrawal (n = 1), and herbal pills (n = 1).
b Defined as <100% but >0% of occasions. No condom use was reported among women who reported sex in the past week.
c One intervention participant was missing results at enrollment.
d Kenyan participants with an OD of >2.1 were considered seropositive.
e Assessed by the Nugent score, with 7–10 indicating bacterial vaginosis, 4–6 indicating intermediate microbiota, and 0–3 indicating normal microbiota.
f Defined as ≥30 polymorphonuclear leukocytes per high-powered field. One participant was missing a baseline result.