Table 1. Sociodemographic, behavioural, and clinical characteristics of the study population by group.
Reference group | Pregnant women1 | Adolescents | Vaginal practices2 | Sex workers | HIV-positive3 | ||||
Kenya N = 110 | South Africa N = 109 | Kenya N = 30 | South Africa N = 30 | Kenya N = 30 | South Africa N = 30 | South Africa N = 31 | Rwanda N = 30 | Rwanda N = 30 | |
N (%)4 | N (%)4 | N (%)4 | N (%)4 | N (%)4 | N (%)4 | N (%)4 | N (%)4 | N (%)4 | |
Socio-demography | |||||||||
Age in years | |||||||||
Mean (range) | 25(18–35) | 25(18–34) | 26(19–34) | 25(18–40) | 16(16–17) | 16(16–17) | 24(19–33) | 27(22–33) | 31(22–35) |
Education | |||||||||
None/some primary | 19(18) | 3(3) | 4(14) | 0 | 7(23) | 0 | 0 | 18(60) | 9(30) |
Primary/some secondary | 52(48) | 23(21) | 10(34) | 10(33) | 19(63) | 30(100) | 12(39) | 12(40) | 10(33) |
Secondary/higher | 37(34) | 84(76) | 15(52) | 20(67) | 4(13) | 0 | 19(61) | 0 | 11(37) |
Marital status | |||||||||
Never married | 29(32) | 83(75) | 2(7) | 19(63) | 28(93) | 30(100) | 27(87) | 21(70) | 5(17) |
Married | 62(57) | 25(23) | 28(93) | 11(37) | 2(7) | 0 | 3(10) | 0 | 18(60) |
Separated/divorced/widowed | 15(14) | 2(2) | 0 | 0 | 0 | 0 | 1(3) | 9(30) | 7(23) |
Living at current address | |||||||||
0–12 months | 27(25) | 25(23) | 11(37) | 11(37) | 3(10) | 2(7) | 12(39) | 2(7) | 6(20) |
>12 months | 83(75) | 84(77) | 19(63) | 19(63) | 27(90) | 28(93) | 19(61) | 28(93) | 24(80) |
Sexual behaviour | |||||||||
Age at first sexual intercourse | |||||||||
Median (range) | 18(10–25) | 18(13–25) | 20(15–33) | 19(15–23) | 15(12–17) | 16(13–17) | 18(15–22) | 16(13–23) | 18(11–24) |
Lifetime number of sex partners | |||||||||
1 | 32(29) | 18(17) | 12(40) | 6(20) | 19(63) | 18(60) | 5(16) | 0 | 2(7) |
2–3 | 63(57) | 50(46) | 15(50) | 17(57) | 6(20) | 11(37) | 13(42) | 0 | 16(53) |
>3 | 15(14) | 41(38) | 3(10) | 7(23) | 5(17) | 1(3) | 13(42) | 30(100) | 12(40) |
Number of sex partners last 3 months 5 | |||||||||
0 | 9(8) | 7(6) | 0 | 1(3) | 4(13) | 2(7) | 1(3) | 0 | 2(7) |
1 | 99(90) | 99(91) | 30(100) | 28(93) | 26(87) | 25(83) | 27(87) | 1(3) | 24(80) |
>1 | 2(2) | 3(3) | 0 | 1(3) | 0 | 3(10) | 3(10) | 29(97) | 4(13) |
Sexual risk taking 6 | |||||||||
Low | 57(52) | 36(33) | 24(80) | 17(57) | 10(33) | 15(50) | 9(29) | 0 | 0 |
Medium | 42(38) | 59(54) | 6(20) | 12(40) | 10(33) | 12(40) | 17(55) | 0 | 0 |
High | 11(10) | 14(13) | 0 | 1(3) | 10(33) | 3(10) | 5(16) | 30(100) | 30(100) |
Frequency of sexual intercourse in the past 3 months | |||||||||
No sexual intercourse | 19(17) | 10(9) | 0 | 1(3) | 7(23) | 12(40) | 4(13) | 0 | 2(7) |
< = 10 times | 32(29) | 40(37) | 6(20) | 3(10) | 14(47) | 15(50) | 12(40) | 10(33) | 8(27) |
11–30 times | 34(31) | 37(34) | 9(30) | 12(40) | 7(23) | 1(3) | 7(23) | 13(44) | 10(33) |
>30 times | 24(22) | 19(17) | 15(50) | 14(47) | 2(7) | 1(3) | 8(23) | 7(24) | 10(33) |
Reported recent vaginal sex at enrolment 7 | 19(17) | 17(16) | 10(33) | 3(10) | 2(7) | 0 | 4(13) | 16(53) | 11(37) |
Seminal factor present at enrolment 8 | 25(23) | 58(55) | 16(53) | 16(59) | 5(17) | 16(59) | 14(45) | 17(57) | 16(53) |
Any sex partners within 3 months of enrolment | 91(83) | 99(91) | 30 (100) | 29(97) | 23(77) | 18(60) | 27(87) | 30(100) | 28(93) |
Condom use with last sexual contact 9 | 24(26) | 38(38) | 0 | 1(3) | 16(70) | 14(78) | 11(41) | 21(70) | 17(61) |
Circumcision status partners 9: All circumcised | 86(96) | 53(59) | 29(97) | 12(43) | 21(100) | 9(56) | 10(42) | 9(30) | 15(56) |
Wash inside vagina when bathing 10 | 66(60) | 37(34) | 11(37) | 6(20) | 13(43) | 9(30) | 28(90) | 18(60) | 13(43) |
Products used in vagina | |||||||||
None | 35(32) | 35(32) | 17(57) | 13(44) | 16(54) | 16(53) | 0 | 10(33) | 12(40) |
Water/fingers only | 26(24) | 51(47) | 3(10) | 13(43) | 4(13) | 8(27) | 0 | 17(57) | 14(47) |
Water and soaps | 31(28) | 23(21) | 7(23) | 2(7) | 7(23) | 4(13) | 1(3) | 3(10) | 1(3) |
Cloth | 16(15) | 0 | 2(7) | 1(3) | 2(7) | 2(7) | 23(74) | 0 | 3(10) |
Lemon juice/detergents | 2(2) | 0 | 1(3) | 1(3) | 1(3) | 0 | 7(23) | 0 | 0 |
Reproductive health | |||||||||
Parity | |||||||||
0 | 24(22) | 34(31) | 11(37) | 20(67) | 24(80) | 27(90) | 5(16) | 1(3) | 3(10) |
1–2 | 62(56) | 60(55) | 15(50) | 9(30) | 6(20) | 3(10) | 24(78) | 21(70) | 17(57) |
>2 | 24(22) | 15(14) | 4(13) | 1(3) | 0 | 0 | 2(6) | 8(27) | 10(33) |
Contraceptive use | |||||||||
None | 25(23) | 18(17) | Not Applicable | 14(47) | 7(23) | 4(13) | 2(7) | 5(17) | |
Condoms only | 24(22) | 28(26) | 12(40) | 18(60) | 11(35) | 7(23) | 9(30) | ||
Combined hormones | 20(18) | 18(17) | 1(3) | 2(7) | 5(16) | 3(10) | 2(7) | ||
Progestin-only injectable | 37(34) | 42(39) | 3(10) | 3(10) | 11(36) | 18(60) | 11(37) | ||
Intrauterine device | 4(4) | 2(2) | 0 | 0 | 0 | 0 | 3(10) | ||
Sterilisation | 0 | 1(1) | 0 | 0 | 0 | 0 | 0 | ||
Vaginal signs and symptoms | |||||||||
Reported abnormal discharge | 4(4) | 11(10) | 0 | 6(20) | 0 | 2(7) | 1(3) | 1(3) | 0 |
Vaginal discharge on speculum examination | 37(34) | 14(13) | 10(33) | 4(13) | 7(23) | 5(17) | 3(10) | 8(27) | 9(30) |
Degree of cervical ectopy | |||||||||
Absent | 75(68) | 46(43) | 24(80) | 19(63) | 23(77) | 18(60) | 13(42) | 6(20) | 5(17) |
Small | 10(9) | 15(14) | 2(7) | 1(3) | 0 | 1(3) | 5(16) | 10(33) | 10(33) |
Moderate | 22(20) | 45(42) | 4(13) | 10(33) | 7(23) | 11(37) | 13(42) | 14(47) | 15(50) |
Large | 3(3) | 2(2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Reproductive tract infections at screening 11 | |||||||||
Herpes simplex virus 2 | 31(28) | 44(40) | 5(17) | 11(37) | 3(10) | 1(3) | 14(45) | 14(47) | 24(83) |
Syphilis | 0 | 0 | 0 | 1(3) | 0 | 0 | 0 | 2(7) | 6(20) |
Neisseria gonorrhoea | 1(1) | 1(1) | 0 | 0 | 0 | 0 | 1(3) | 2(7) | 4(13) |
Chlamydia trachomatis | 4(4) | 18(17) | 2(7) | 4(13) | 0 | 4(13) | 8(26) | 3(10) | 0 |
Trichomonas vaginalis | 3(3) | 5(5) | 1(3) | 3(10) | 4(13) | 0 | 4(14) | 3(10) | 3(10) |
Candida species | 13(12) | 29(27) | 7(23) | 17(57) | 1(3) | 11(37) | 10(32) | 3(10) | 4(13) |
Nugent score at screening: Mean (SD) | 3.7(4.0) | 3.4(4.1) | 3.2(3.9) | 3.8(4.4) | 2.3(3.5) | 5.3(4.4) | 4.0(3.9) | 4.7(3.8) | 4.1(3.8) |
Bacterial vaginosis at screening | |||||||||
Normal (Nugent 0–3) | 48(51) | 60(59) | 17(61) | 16(55) | 20(69) | 11(38) | 14(48) | 10(37) | 12(43) |
Intermediate (Nugent 4–6) | 12(13) | 2(2) | 2(7) | 2(7) | 3(10) | 1(3) | 5(17) | 5(19) | 6(21) |
Bacterial vaginosis (Nugent 7–10) | 34(36) | 39(39) | 9(32) | 11(38) | 6(21) | 17(59) | 10(34) | 12(44) | 10(36) |
Nugent score at enrolment: Mean (SD) | 3.6(4.0) | 2.8(4.0) | 2.6(3.9) | 2.9(4.0) | 2.4(3.6) | 4.7(4.3) | 3.1(3.9) | 5.8(3.5) | 4.5(4.3) |
Bacterial vaginosis at enrolment | |||||||||
Normal (Nugent 0–3) | 55(55) | 63(65) | 19(68) | 18(62) | 18(67) | 13(45) | 16(59) | 6(24) | 13(48) |
Intermediate (Nugent 4–6) | 8(8) | 6(6) | 1(4) | 2(7) | 4(15) | 4(14) | 1(4) | 2(8) | 1(4) |
Bacterial vaginosis (Nugent 7–10) | 37(37) | 28(29) | 8(29) | 9(31) | 5(19) | 12(41) | 10(37) | 17(68) | 13(48) |
New systemic Antibiotic use 14 days before enrolment | 11(10) | 19(17) | 5(17) | 7(23) | 4(13) | 4(13) | 4(13) | 4(13) | 4(13) |
Pregnant: up to 14 weeks gestational age at enrolment as defined by abdominal ultrasound;
Vaginal Practices: using other substances than the use of water, soap and/or fingers alone;
HIV-positive women: on antiretroviral treatment for at least 6 months, currently asymptomatic, and a CD4 count of more than 350 cells/µl.
N (%) of women with the characteristic; mean/median (range) when otherwise specified;
Last 3 months prior to screening visit;
Sexual risk taking: Low risk: 1 or no partners in last year AND did not have any partner (in the last 3 months) with multiple partners AND age first sex at least 15 years; Medium risk: 2 partners last year OR had at least one sexual partner (in the last 3 months) who had multiple partners; High risk: sex worker OR at least 3 partners last year OR at had at least one sexual partner with HIV in the last 3 months OR age first sex less than 15 years.
Recent vaginal sex: vaginal sex this morning and/or yesterday evening before enrolment visit;
Prostate specific antigen present in vaginal fluid, including weak reaction.
With partners in the 3 months prior to enrolment;
Most of the time/every time.
Data for Trichomonas vaginalis testing was unavailable for 8 women, HSV-2 for one, and Nugent scores slides were unreadable at screening for 36 and at enrolment for 41.