Table 2. Enrollment and HIV incidence among at-risk volunteers enrolled for HIV prevention preparatory studies stratified by CRC and, where appropriate, sex.
| CRC and study population | Enrollment years | Year of last study visit | Total enrolled | Total PY | HIV cases detected | HIV incidence | 95% CI | p value ** | ref. *** |
|---|---|---|---|---|---|---|---|---|---|
| HIV discordant couples | |||||||||
| Kigali, Rwanda | Stephenson, 2008; Wall, 2012 | ||||||||
| DC male negative | 2002–11 * | 2011 | 972 | 1844 | 64 | 3.5 | (2.7, 4.4) | 0.16 | |
| DC female negative | 2002–11 * | 2011 | 884 | 1705 | 45 | 2.6 | (1.9, 3.5) | ||
| Lusaka, Zambia | Kempf, 2008; Stephenson, 2008 | ||||||||
| DC male negative | 1995–11 * | 2011 | 1656 | 3367 | 226 | 6.7 | (5.9, 7.7) | 0.003 | |
| DC female negative | 1995–11 * | 2011 | 1393 | 2848 | 252 | 8.9 | (7.8, 10.0) | ||
| Ndola, Zambia | Lambdin, 2011 | ||||||||
| DC male negative | 2004–11 | 2011 | 416 | 575 | 35 | 6.1 | (4.2, 8.5) | 0.01 | |
| DC female negative | 2004–11 | 2011 | 335 | 399 | 43 | 10.8 | (7.8, 14.5) | ||
| Masaka, Uganda | Ruzagira, 2011 (a) | ||||||||
| DC male negative | 2006–11 | 2011 | 581 | 1143 | 44 | 3.8 | (2.9, 5.2) | 0.44 | |
| DC female negative | 2006–11 | 2011 | 313 | 514 | 24 | 4.7 | (3.1, 7.0) | ||
| Masaka, Uganda | Ruzagira, 2011 (a) | ||||||||
| DC on ART ∞ | 2006–09 | 2009 | 152 | 271 | 3 | 1.1 | (0, 2.4) | — | |
| Entebbe, Uganda | NA | ||||||||
| DC male negative | 2006–09 | 2010 | 276 | 345 | 5 | 1.4 | (0.6, 3.5) | 0.27 | |
| DC female negative | 2006–09 | 2010 | 322 | 416 | 11 | 2.6 | (1.5, 4.8) | ||
| Men who have sex with men | |||||||||
| Kilifi, Kenya | 2005–2012 ▪ | 2013 ▪ | 726 | 996 | 73 | 7.3 | (5.8–9.2) | — | Price, 2012; Sanders, 2013 |
| Nairobi, Kenya | 2006–09 | 2010 | 303 | 338 | 19 | 5.6 | (3.6, 8.8) | — | Price, 2012 |
| Rustenburg, South Africa | 2009–10 | 2011 | 29 | 21 | 2 | 9.5 | (2.4, 38.0) | — | NA |
| At-risk women | |||||||||
| Cape Town, South Africa | Price, 2012 | ||||||||
| Younger women ▪▪ | 2006–7 | 2008 | 337 | 284 | 8 | 2.8 | (1.4, 5.6) | — | |
| Rustenburg, South Africa | |||||||||
| Women, clinic and community based | 2008–9 | 2009 | 223 | 67 | 2 | 3.0 | (0.4, 10.8) | — | Feldblum, 2012 |
| Peripheral community residents | 2010–11 | 2012 | 323 | 213 | 19 | 8.9 | (5.7, 14.0) | — | NA |
| Kilifi, Kenya | Price, 2012 | ||||||||
| Female sex workers | 2005–2010 | 2012 | 315 | 552 | 13 | 2.4 | (1.4, 4.1) | — | |
| Fishing Community members | |||||||||
| Masaka, Uganda | NA | ||||||||
| Male | 2012–13 | 2013 ▪ | 327 | 244 | 13 | 5.3 | (3.1, 9.2) | 0.10 | |
| Female | 2012–13 | 2013 ▪ | 217 | 139 | 14 | 10.1 | (6.0, 17.0) | ||
| Masaka and Entebbe, Uganda | Seely, 2012 | ||||||||
| Male | 2009–10 | 2011 | 450 | 652 | 34 | 4.5 | (3.1, 6.7) | 0.59 | |
| Female | 2009–10 | 2011 | 550 | 554 | 25 | 5.2 | (3.7, 7.3) |
* IAVI support initiated in 2004
** p value for the incident rate ratio calculator comparing HIV incidence by sex, where study populations are stratified by sex
*** For additional details on recruitment, demographics, follow up and earlier reports of HIV incidence. With the exception of Feldblum 2012, all the data above and in Table 3 represents new analyses and additional follow up time.
▪ Cohort enrollment currently open
▪▪ Recruited women from 16 years old; the only cohort to recruit <18 year olds
∞ HIV positive partner in the DC cohort is on ART, too few to analyze by volunteer sex (87 negative men, 65 women)
PY: Person years, IQR: Interquartile range, CI: Confidence Interval, CRC: Clinical Research Center, DC: Discordant Couple (reported sex applies to enrolled HIV uninfected volunteers, HIV infected volunteers were all ART-naive except where noted), NA: reference not available, data not previously published