Table 1.
Demographic and clinical characteristics and risk behaviors at enrollment by treatment group in the TDF2 clinical trial. Botswana 2007–2010.
| Demographic Characteristic or Risk Behavior |
Combined (N=1219) |
TDF/FTC (N=611) |
Placebo (N=608) |
p-value |
|---|---|---|---|---|
| Gender | ||||
| Male | 662 (54.3) | 331 (54.2) | 331 (54.4) | 0.9254 |
| Female | 557 (45.7) | 280 (45.8) | 277 (45.6) | |
| Education | ||||
| Primary or less | 40 (3.3) | 20 (3.3) | 20 (3.3) | 0.9962 |
| Secondary (Jr/Sr) | 891 (73.1) | 446 (73.0) | 445 (73.2) | |
| Postsecondary | 288 (23.6) | 145 (23.7) | 143 (23.5) | |
| Marital Status | ||||
| Married or Cohabitating | 70 (5.7) | 32 (5.2) | 38 (6.3) | 0.4465 |
| Single | 1145 (93.9) | 578 (94.6) | 567 (93.3) | |
| Separated or Divorced | 4 (0.3) | 1 (0.2) | 3 (0.5) | |
| Screening Site | ||||
| Gaborone | 651 (53.4) | 326 (53.4) | 325 (53.5) | 0.9724 |
| Francistown | 568 (46.6) | 285 (46.6) | 283 (46.6) | |
| Occupational Status Employed Unemployed |
480 (39.4) 739 (60.6) |
245 (40.1) 366 (59.9) |
235 (38.7) 373 (61.4) |
0.6052 |
| HIV | ||||
| Positive | 3 (0.3) | 1 (0.2) | 2 (0.3) | 0.5603 |
| Negative | 1216 (99.8) | 610 (99.8) | 606 (99.7) | |
| Syphilis | ||||
| Positive | 14 (1.2) | 5 (0.8) | 9 (1.5) | 0.5462 |
| Negative | 1182 (97.0) | 594 (97.2) | 588 (96.7) | |
| Missing | 23 (1.9) | 12 (2.0) | 11 (1.8) | |
| Gonorrhea | ||||
| Positive | 24 (2.0) | 12 (2.0) | 12 (2.0) | 0.4820 |
| Negative | 1119 (91.8) | 566 (92.6) | 553 (91.0) | |
| Missing | 76 (6.2) | 33 (5.4) | 43 (7.1) | |
| Trichomonas* | ||||
| Positive | 33 (5.9) | 19 (6.8) | 14 (5.1) | 0.5400 |
| Negative | 471 (84.6) | 237 (84.6) | 234 (84.5) | |
| Missing | 53 (9.5) | 24 (8.6) | 29 (10.5) | |
| Chlamydia | ||||
| Positive | 97 (8.0) | 43 (7.0) | 54 (8.9) | 0.2435 |
| Negative | 1047 (85.9) | 535 (87.6) | 512 (84.2) | |
| Missing | 75 (6.2) | 33 (5.4) | 42 (6.9) | |
| HSV-2 | ||||
| Positive | 428 (35.1) | 208 (34.0) | 220 (36.2) | 0.2082 |
| Negative | 766 (62.8) | 392 (64.2) | 374 (61.5) | |
| Indeterminate | 7 (0.6) | 1 (0.2) | 6 (1.0) | |
| Missing | 18 (1.5) | 10 (1.6) | 8 (1.3) | |
| Number of Sex Partners Last Month |
||||
| 0 | 151 (12.4) | 73 (12.0) | 78 (12.8) | |
| 1 | 815 (66.9) | 410 (67.1) | 405 (66.6) | |
| 2 | 172 (14.1 | 86 (14.1) | 86 (14.1) | |
| 3+ | 60 (4.9) | 32 (5.2) | 28 (4.6) | |
| Missing | 21 (1.7) | 10 (1.6) | 11 (1.8) | 0.9732 |
| Total Number of All Sex Acts with Any Partner Last Month |
||||
| 0 | 175 (14.4) | 87 (14.2) | 8 (14.5) | 0.9815 |
| 1 | 94 (7.7) | 45 (7.4) | 849 (8.1) | |
| 2 | 143 (11.7) | 74 (12.1) | 69 (11.4) | |
| 3+ | 786 (64.5) | 395 (64.7) | 391 (64.3) | |
| Missing | 21 (1.7) | 10 (1.6) | 11 (1.8) | |
| Number of Condomless Sex Acts (Any) Last Month |
||||
| 0 | 805 (66.0) | 402 (65.8) | 403 (66.3) | 0.1976 |
| 1 | 67 (5.5) | 31 (5.1) | 36 (5.9) | |
| 2 | 38 (3.1) | 27 (4.4) | 11 (1.8) | |
| 3+ | 137 (11.2) | 68 (11.1) | 69 (11.4) | |
| Did Not Have Sex | 151 (12.4) | 73 (12.0) | 78 (12.8) | |
| Missing | 21 (1.7) | 10 (1.6) | 11 (1.8) |
Note: There were 1219 subjects enrolled in the study. However, 18 of these subjects were carried over from the TDF1 study and were never screened for the TDF2 analysis. So, the “Screened and Enrolled” population for the TDF2 study consists of the original 1219 minus the 18 carryover subjects (n=1201). The analytic dataset for this study was constructed using a different set of inclusion criteria. We included the carryover participants. Our analysis, however, excludes 3 subjects because they were diagnosed HIV+ by blood test at enrollment. Also, 16 subjects were excluded because they never received their medication. So there were 1200 subjects included in the actual analysis (the original 1219 minus the 19 who were deemed ineligible).