Table 1.
Baseline characteristics by random on-site monitoring assignment
| Site Characteristic | On-site | No on-site |
|---|---|---|
| No. sites | 99 | 97 |
| Prior experience with INSIGHT (%)a | 66.7 | 69.1 |
| On-site monitored before start of substudy (%)b | 35.4 | 39.2 |
| Study enrollment (%) | ||
| < 15 participants | 57.6 | 56.7 |
| 15-30 participants | 22.2 | 27.8 |
| > 30 participants | 20.2 | 15.5 |
| Geographic region | ||
| Africa | 6.1 | 4.1 |
| Asia | 5.1 | 7.2 |
| Australia | 6.1 | 7.2 |
| Europe and Israel | 43.4 | 42.3 |
| North America | 28.3 | 25.8 |
| South America and Mexico | 11.1 | 13.4 |
| Participant Characteristic | On-site | No on-site |
| No. participants | 2107 | 2264 |
| Age (years); median (IQR) | 35 (28, 43) | 36 (29, 44) |
| Gender (% female) | 31.0 | 25.8 |
| Race (%) | ||
| Asian | 7.8 | 9.8 |
| Black | 30.1 | 33.7 |
| Latino/Hispanic | 15.4 | 13.6 |
| White | 44.7 | 37.5 |
| Other | 1.9 | 5.3 |
| Geographic region | ||
| Africa | 23.6 | 22.3 |
| Asia | 7.0 | 9.2 |
| Australia | 2.0 | 3.0 |
| Europe and Israel | 29.0 | 27.3 |
| North America | 13.1 | 10.0 |
| South America and Mexico | 25.3 | 28.3 |
| Current smoker (%) | 29.4 | 31.5 |
| CD4+ (cells/mm3), median (IQR) | 660 (588, 777) | 648 (581, 759) |
| HIV-RNA (log10 copies/mL); median (IQR) | 4.1 (3.5, 4.6) | 4.1 (3.5, 4.6) |
| Hepatitis B (%) | 2.4 | 3.4 |
| Hepatitis C (%) | 3.9 | 3.4 |
| Framingham CHD 10-yr risk; median (IQR) | 1.7 (0.4, 4.7) | 1.9 (0.5, 5.1) |
a
Participated in either INSIGHT’s SMART or ESPRIT study
b
START opened on 09 April 2009 and the monitoring substudy opened on 01 September 2011
CHD = coronary heart disease