Table 4 Percentage of participants engaging in specific intravaginal practices and laboratory parameters (vaginal flora, bacterial vaginosis, plasma, genital HIV RNA, IL-6, and IL-8) by condition. Plasma and CVL HIV RNA limit of detection was 20 copies/milliliter
Experimental (SOC+ plus group intervention) | Enhanced standard of care (SOC+) | SOC+ versus experimental | ||||||
|---|---|---|---|---|---|---|---|---|
N(%) Median(IQR) | N(%) Median(IQR) | |||||||
Baseline (N = 58) | 6-month (N = 47) | 12-month (N = 54) | Baseline (N = 70) | 6-month (N = 53) | 12-month (N = 64) | 6-month p-value | 12-month p-value | |
Products used for intravaginal practices in the prior month | ||||||||
Water | 90.9% | 31.0% | 40.7% | 92.5% | 45.8% | 54.7% | 0.159 | 0.140 |
Soap | 63.6% | 4.8% | 27.8% | 74.6% | 29.2% | 46.9% | 0.013 | 0.042 |
Cloth, sponge or a rag | 54.6% | 2.4% | 18.5% | 52.2% | 16.7% | 37.5% | 0.061 | 0.031 |
Traditional medicines | 27.3% | 2.4% | 22.2% | 29.9% | 6.3% | 42.2% | 0.395 | 0.029 |
Herbs or flowers from outdoors | 20.0% | 2.4% | 5.6% | 16.4% | 10.4% | 14.1% | 0.170 | 0.147 |
Lemon | 10.9% | 2.4% | 9.3% | 9.0% | 2.1% | 20.3% | 0.924 | 0.111 |
Salt | 7.3% | 2.4% | 5.6% | 10.5% | 2.1% | 7.8% | 0.924 | 0.629 |
Vinegar | 3.6% | 2.4% | 7.4% | 1.5% | 2.1% | 18.8% | 0.924 | 0.090 |
Laboratory parameters | ||||||||
Abnormal vaginal flora | 72.7% | 61.0% | 66.7% | 82.1% | 60.0% | 50.9% | 0.926 | 0.090 |
Bacterial vaginosis | 60.0% | 22.0% | 27.5% | 68.7% | 11.1% | 20.3% | 0.186 | 0.383 |
Detectable plasma HIV RNA | 18.2% | 11.9% | 11.1% | 23.9% | 18.8% | 38.9% | 0.379 | 0.086 |
Detectable CVL HIV RNA | 12.7% | 5.0% | 5.6% | 14.9% | 15.9% | 20.0% | 0.134 | 0.244 |
IL-6 (n = 68; Exp = 35, SOC+ = 33) | 306.3 (313.7) | 326.0 (313.1) | -- | 282.6 (249.1) | 330.1 (261.6) | -- | 0.762 | -- |
IL-8 (n = 68; Exp = 35, SOC+ = 33) | 380.11 (1311.9) | 328.0 (1423.5) | -- | 227.5 (2285.5) | 254.2 (1385.5) | -- | 0.651 | -- |