Background
Methods
Ethics statement
Study setting
Participants
Study procedures
Enhanced standard of care condition
Experimental condition: SOC+ plus group intervention
Assessments
Demographics, sexual risk factors and medical history
Intravaginal practices
Genital tract examination and collection of genital samples
Bacterial vaginosis
Plasma viremia and HIV-1 genital shedding
Cytokine analysis
Statistical analysis
Results
Participants
Demographics
Condition N(%) Median(IQR) | ||||
---|---|---|---|---|
All participants | Experimental (n = 58) | SOC+ (n = 70) |
p-value | |
Age | 35.00 (11.00) | 37.00 (14.00) | 34.00 (10.00) | 0.402a
|
Educational attainment | ||||
None | 8 (6.3%) | 4 (6.9%) | 4 (5.7%) | |
Primary School | 58 (45.3%) | 30 (51.7%) | 28 (40.0%) | |
Secondary School | 55 (43.0%) | 21 (36.2%) | 34 (48.6%) | |
College/University | 7 (5.5%) | 3 (5.2%) | 4 (5.7%) | 0.514b
|
Employment status | ||||
Work full time | 23 (18.0%) | 6 (10.3%) | 17 (24.3%) | |
Work part time | 7 (5.5%) | 4 (6.9%) | 3 (4.3%) | |
Not working | 89 (69.5%) | 43 (74.1%) | 46 (65.7%) | |
Volunteering | 9 (7.0%) | 5 (8.6%) | 4 (5.7%) | 0.206b
|
Monthly income (Zambian Kwacha) | ||||
Less 500 (less than 65 USD) | 16 (12.5%) | 9 (15.5%) | 7 (10.0%) | |
500 to 1000 (~ 65–130 USD) | 82 (64.1%) | 32 (55.2%) | 50 (71.4%) | |
1000 to 2000 (130–260 USD) | 28 (21.9%) | 16 (27.6%) | 12 (17.1%) | |
More than 5000 (> 260 USD) | 2 (1.6%) | 1 (1.7%) | 1 (1.4%) | 0.242b
|
Marital status | ||||
Single | 25 (19.5%) | 10 (17.2%) | 15 (21.4%) | |
Stable relationship | 93 (72.7%) | 39 (67.2%) | 54 (77.1%) | |
Unstable relationship | 10 (7.8%) | 9 (15.5%) | 1 (1.4%) |
0.013
b
|
Children | ||||
No | 4 (3.1%) | 1 (1.7%) | 3 (4.3%) | |
Yes | 124 (96.9%) | 57 (98.3%) | 67 (95.7%) | 0.626b
|
Treatment of STIs in the past year (n = 30 women with STIs) | ||||
No | 7 (23.3%) | 5 (41.7%) | 2 (11.1%) | |
Yes | 23 (76.7%) | 7 (58.3%) | 16 (88.9%) | 0.084b
|
Partner status | ||||
Unknown | 42 (32.8%) | 19 (32.8%) | 23 (32.9%) | |
Positive | 86 (67.2%) | 39 (67.2%) | 47 (67.1%) | > 0.999 |
Disclosure of HIV status to partner | ||||
No | 10 (7.8%) | 4 (6.9%) | 6 (8.6%) | |
Yes | 118 (92.2%) | 54 (93.1%) | 64 (91.4%) | > 0.999b
|
Sex in exchange for compensation | ||||
Never in the past month | 115 (89.8%) | 52 (89.7%) | 63 (90.0%) | |
Sometimes | 12 (9.4%) | 6 (10.3%) | 6 (8.6%) | |
All the time | 1 (0.8%) | 0 (0.0%) | 1 (1.4%) | 0.874b
|
Number of partners in the prior 3 months | 1.00 (0.00) | 1.00 (0.00) | 1.00 (0.00) | 0.608a
|
Condom use in the past month | ||||
100% of the time | 4 (4.3%) | 1 (2.3%) | 3 (5.9%) | |
Less than 100% of the time | 90 (95.7%) | 42 (97.7%) | 48 (94.1%) | 0.395b
|
Time since diagnosis | ||||
Less than a year ago | 12 (9.4%) | 5 (8.6%) | 7 (10.0%) | |
Between one and 5 years ago | 75 (58.6%) | 37 (63.8%) | 38 (54.3%) | |
Between 5 and 10 years ago | 33 (25.8%) | 14 (24.1%) | 19 (27.1%) | |
More than 10 years ago | 8 (6.3%) | 2 (3.4%) | 6 (8.6%) | 0.573b
|
CD4 cells per milliliter | ||||
Less than 100 | 7 (5.5%) | 2 (3.4%) | 5 (7.1%) | |
100 to 500 | 49 (38.3%) | 23 (39.7%) | 26 (37.1%) | |
More than 500 | 50 (39.1%) | 21 (36.2%) | 29 (41.4%) | |
I do not know | 22 (17.2%) | 12 (20.7%) | 10 (14.3%) | 0.623a
|
Products used for IVP
Condition N(%) Median(IQR) | ||||
---|---|---|---|---|
All | Experimental (n = 58) | SOC+ (n = 70) |
p-value | |
Product use for IVP in the prior month | ||||
Water | ||||
No | 10 (7.8%) | 5 (8.6%) | 5 (7.1%) | |
Yes | 118 (92.2%) | 53 (91.4%) | 65 (92.9%) | 0.755a
|
Soap | ||||
No | 39 (30.5%) | 22 (37.9%) | 17 (24.3%) | |
Yes | 89 (69.5%) | 36 (62.1%) | 53 (75.7%) | 0.095 |
Cloth, sponge or a rag | ||||
No | 33 (47.1%) | 27 (46.6%) | 33 (47.1%) | |
Yes | 68 (53.1%) | 31 (53.4%) | 37 (52.9%) | > 0.999 |
Traditional medicines | ||||
No | 91 (71.1%) | 43 (74.1%) | 48 (68.6%) | |
Yes | 37 (28.9%) | 15 (25.9%) | 22 (31.4%) | 0.489 |
Herbs or flowers from outdoors | ||||
No | 103 (80.5%) | 46 (79.3%) | 57 (81.4%) | |
Yes | 25 (19.5%) | 12 (20.7%) | 13 (18.6%) | 0.763 |
Lemon | ||||
No | 115 (89.3%) | 52 (89.7%) | 63 (90.0%) | |
Yes | 13 (10.2%) | 6 (10.3%) | 7 (10.0%) | > 0.999 |
Salt | ||||
No | 117 (91.4%) | 54 (93.1%) | 63 (90.0%) | |
Yes | 11 (8.6%) | 4 (6.9%) | 7 (10.0%) | 0.753a
|
Vinegar | ||||
No | 124 (96.9%) | 56 (96.6%) | 68 (97.1%) | |
Yes | 4 (3.1%) | 2 (3.4%) | 2 (2.9%) | 0.848a
|
Laboratory parameters | ||||
Abnormal vaginal flora | ||||
No | 30 (23.4%) | 16 (27.6%) | 14 (20.0%) | |
Yes | 98 (76.6%) | 42 (72.4%) | 56 (80.0%) | 0.213 |
Bacterial vaginosis | ||||
No | 47 (36.7%) | 24 (41.4%) | 23 (32.9%) | |
Yes | 81 (63.3%) | 34 (58.6%) | 47 (67.1%) | 0.319 |
Plasma HIV RNA | ||||
Undetectable | 100 (78.1%) | 46 (79.3%) | 54 (77.1%) | |
Detectable | 28 (21.9%) | 12 (20.7%) | 16 (22.9%) | 0.768 |
CVL HIV RNA | ||||
Undetectable | 108 (84.4%) | 50 (86.2%) | 58 (82.9%) | |
Detectable | 20 (15.6%) | 8 (13.8%) | 12 (17.1%) | 0.603 |
Lower genital tract cytokines | ||||
IL-6 (n = 68; Exp = 35, SOC+ = 33) | 289.9 (258.0) | 306.3 (313.7) | 282.6 (249.1) | 0.944 |
IL-8 (n = 68; Exp = 35, SOC+ = 33) | 332.5 (1781.9) | 380.11 (1311.9) | 227.5 (2285.5) |
< 0.001
|
Laboratory parameters
IVP and laboratory parameters
Self-reported IVP use over time and by condition
Baseline (N = 128) N(%) Median(IQR) | 6-month (N = 90) N(%) Median(IQR) | 12-month (N = 118) N(%) Median(IQR) | Baseline vs. 6-month
p-value | Baseline vs. 12-month
p-value | 6-month vs. 12-month
p-value | |
---|---|---|---|---|---|---|
Products used for intravaginal practices in the prior month | ||||||
Water | 91.7% | 37.7% | 47.2% |
< 0.001
|
< 0.001
| 0.112 |
Soap | 68.9% | 11.8% | 36.1% |
< 0.001
|
< 0.001
|
0.001
|
Cloth, sponge or a rag | 53.4% | 6.3% | 26.4% |
< 0.001
|
< 0.001
|
0.010
|
Traditional medicine | 28.5% | 3.8% | 30.6% |
0.001
| 0.731 |
< 0.001
|
Herbs or flowers from outdoors | 18.1% | 5.0% | 8.8% |
0.026
| 0.070 | 0.363 |
Lemon | 9.9% | 2.2% | 13.7% | 0.050 |
0.034
|
0.016
|
Salt | 8.7% | 2.2% | 6.6% | 0.077 | 0.503 | 0.172 |
Vinegar | 2.3% | 2.2% | 11.8% | 0.962 |
0.017
|
0.029
|
Laboratory parameters | ||||||
Abnormal vaginal flora | 77.3% | 60.5% | 58.2% |
0.014
|
0.003
| 0.752 |
Bacterial vaginosis | 64.2% | 15.6% | 23.6% |
< 0.001
|
< 0.001
| 0.145 |
Detectable plasma HIV RNA | 20.8% | 14.9% | 20.7% | 0.147 | 0.995 | 0.374 |
Detectable CVL HIV RNA | 13.8% | 8.9% | 8.9% | 0.314 | 0.618 | 0.800 |
IL-6 (n = 68) | 289.9 (258.0) | 328.03 (264.8) | -- | 0.158 | -- | -- |
IL-8 (n = 68) | 332.5 (1781.9) | 311.4 (1400.3) | -- | 0.272 | -- | -- |
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 | -- |