Background
Methods
Study design and procedures
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | |
---|---|---|---|---|---|---|---|---|---|
Visit Month (Study Month = 28 days)
|
M0
|
M 1
|
M 3
|
M 6
|
M 9
|
M 12
| |||
Visit Window (Days)
| ± 1 | ± 3 | ± 1 | ± 7 | ± 3 | ± 1 | ± 7 | ± 7 | |
Vaccination Visit
|
X
|
X
|
X
| ||||||
3-day post vaccination
|
X
|
X
|
X
|
Study population and sampling
Sample size determination
Volunteer retention
Laboratory methods
Data collection
Statistical methods
Results
Baseline characteristics of FSWs enrolled in the SiVET study in Kampala, Uganda
Variable | Sub Category | Total n (%) | Completed All Vaccinations n (%) | Completed All Vaccinations and Month 12 visit n (%) |
---|---|---|---|---|
Overall | 290 (100) | 239 (82.4) | 212 (73.1) | |
Age (Yrs) | 35+ | 62 (21.4) | 58 (93.6) | 55 (88.7) |
18–34 | 228 (78.6) | 181 (79.4) | 157 (68.9) | |
Education | None | 16 (5.5) | 12 (75.0) | 10 (62.5) |
Primary | 149 (51.4) | 123 (82.6) | 112 (75.2) | |
Secondary or higher | 125 (43.1) | 104 (83.2) | 90 (72.0) | |
Marital Status | Single never married | 68 (23.4) | 58 (85.3) | 52 (76.5) |
Married | 18 (6.2) | 14 (77.8) | 13 (72.2) | |
Separated or widowed | 204 (70.3) | 167 (81.9) | 147 (72.1) | |
Alcohol use in the past month | None | 57 (19.7) | 44 (77.2) | 41 (71.9) |
≤ once a week | 148 (51.0) | 128 (86.5) | 110 (74.3) | |
Daily | 85 (29.3) | 67 (78.8) | 61 (71.8) | |
Drug use in the past month | No | 213 (73.4) | 177 (83.1) | 159 (74.7) |
Yes | 77 (26.6) | 62 (80.5) | 53 (68.8) | |
Drunk before sex in the past month | Never | 103 (35.5) | 86 (83.5) | 83 (80.6) |
Sometimes/ most times | 170 (58.6) | 140 (82.4) | 119 (70.0) | |
Always | 17 (5.9) | 13 (76.5) | 10 (58.8) | |
Reported VDS in past 3 months | No | 204 (70.3) | 174 (85.3) | 154 (75.5) |
Yes | 86 (29.7) | 65 (75.6) | 58 (67.4) | |
Reported GUD in past 3 months | No | 236 (81.4) | 200 (84.8) | 179 (75.9) |
Yes | 54 (18.6) | 39 (72.2) | 33 (61.1) | |
Number of Sexual partners in past 3 months | 0–2 | 14 (4.9) | 11 (78.6) | 10 (71.4) |
0–3 | 61 (21.0) | 53 (86.9) | 50 (82.0) | |
≥ 6 | 215 (74.1) | 175 (81.4) | 152 (70.7) | |
New sexual partner in past 3 months | No | 16 (5.5) | 12 (75.0) | 10 (62.5) |
Yes | 274 (94.5) | 227 (82.9) | 202 (73.7) | |
Condom use with new partner(s) | Never | 3 (1.1) | 3 (100) | 3 (100) |
Sometimes/ most times | 52 (19.0) | 48 (92.3) | 42 (80.8) | |
Always | 219 (79.9) | 176 (80.4) | 157 (71.7) | |
Receiving payment for sex in past 3 months | No | 1 (0.3) | 1 (100) | 1 (100) |
Yes | 289 (99.7) | 238 (82.4) | 211 (73.0) | |
Giving payment for sex in past 3 months | No | 243 (83.8) | 202 (83.1) | 181 (74.5) |
Yes | 47 (16.2) | 37 (78.7) | 31 (66.0) |
Factors associated with missing any vaccination visit and drop out
Variable | Sub Category | Missing any one vaccination visit | Non retention | ||||
---|---|---|---|---|---|---|---|
Unadjusted IRR (95%CI) | LRT-p value | Adjusted IRR (95%CI) | Unadjusted IRR (95%CI) | LRT-p value | Adjusted IRR (95%CI) | ||
Age (years) | 35+ | 1.00 |
0.013
| 1.00 | 1.00 |
0.002
| 1.00 |
18–34 |
3.59 (1.31–9.83)
|
13.10 (1.89–90.92)
|
3.24 (1.52–6.88)
|
6.59 (2.11–20.57)
| |||
Education level | None | 1.00 | 0.666 | 1.00 | 0.492 | ||
Primary | 0.67 (0.24–1.86) | 0.61 (0.27–1.37) | |||||
Secondary or higher | 0.62 (0.22–1.74) | 0.67 (0.30–1.50) | |||||
Marital Status | Single never married | 1.00 | 0.669 | 1.0 | 0.714 | ||
Married | 1.62 (0.53–4.93) | 1.32 (0.51–3.40) | |||||
Separated or widowed | 1.27 (0.63–2.54) | 1.24 (0.72–2.12) | |||||
Alcohol use in the past month | None | 1.00 | 0.226 | 1.00 | 0.327 | ||
Once a week or less | 0.59 (0.31–1.14) | 0.73 (0.42–1.25) | |||||
Daily | 0.91 (0.46–1.78) | 1.02 (0.58–1.80) | |||||
Drug use in the past month | No | 1.00 | 0.841 | 1.00 | 0.295 | ||
Yes | 1.06 (0.58–1.94) | 1.28 (0.80–2.05) | |||||
Drunk before sex in past month | Never | 1.00 | 0.903 | 1.00 | 0.973 | ||
Sometimes /most times | 0.98 (0.56–1.71) | 1.03 (0.66–1.61) | |||||
Always | 0.72 (0.17–2.99) | 0.91 (0.29–2.87) | |||||
Reported VDS in past 3 months | No | 1.00 | 0.217 | 1.00 | 0.998 | ||
Yes | 1.42 (0.81–2.45) | 0.99 (0.62–1.62) | |||||
Reported GUD in past 3 months | No | 1.00 | 0.003 | 1.00 | 1.00 |
0.012
| 1.00 |
Yes |
2.44 (1.36–4.37)
|
3.02 (1.71–5.33)
| 1.58 (0.93–2.68) |
1.90 (1.09–3.32)
| |||
Number of sexual partners | 0–2 | 1.00 | 0.866 | 1.00 | 0.427 | ||
3–5 | 1.04 (0.31–3.53) | 0.71 (0.29–1.72) | |||||
6+ | 1.22 (0.40–3.71) | 1.06 (0.51–2.21) | |||||
New sexual partner in past 3 months | No | 1.00 | 0.481 | 1.00 | 0.268 | ||
Yes | 0.73 (0.31–1.74) | 0.71 (0.38–1.31) | |||||
Condom use with new partner(s) | Never/Inconsistently | 1.00 |
0.03
| 1.00 | 1.00 | 0.060 | 1.00 |
Consistently | 2.06 (0.82–5.20) |
2.57 (1.10–6.07)
| 2.08 (0.97–4.47) | 2.04 (1.00–4.15) | |||
Giving payment for sex in past 3 months | No | 1.00 | 0.380 | 1.00 | 0.204 | ||
Yes | 1.35 (0.69–2.63) | 1.42 (0.83–2.42) |