Socio-demographics and sexual behaviors
The age distribution among 18–24 year-old men was similar across sites (). A greater proportion of men in Rakai were currently married or living as married as compared to other participants. Among Orange Farm participants, 108 (8.4%) reported no sexual activity at enrollment, although 24 of these men reported sexual activity at their 3-month follow-up visit. Among 1,095 Rakai participants aged 18–24, 140 (12.8%) reported no sexual activity at enrollment and none of these men reported sexual activity at their 4-week follow-up. Kisumu participants were younger at sexual debut, had longer duration of sexual activity, and reported more partners during the past 12 months and in their lifetimes than the other trial sites.
Socio-Demographic and Sexual Behaviors at Enrollment of HIV-Negative Men Enrolled in Randomized Controlled Trials of Male Circumcision, Who Were Randomized to and Underwent Circumcision, by Trial Site.
The 30-day and 4-week follow-up visits were attended by 1,266 (95.1%) of Kisumu participants, and 2,282 (98.1%) of Rakai participants [1,068 (97.5%) aged 18–24] (). For Orange Farm, 1,293 of men attended the 3-month follow-up visit. Most 30-day and 4-week visits occurred 28–34 days after circumcision for Kisumu (89.7%) and Rakai (72.8%) participants. Among 18–24 year-olds, the proportion of men reporting early sex was similar for Kisumu (3.9%) and Rakai (5.4%) participants, but was much higher among Orange Farm trial participants (22.5%).
Follow-up Visits and Sexual Activity After Circumcision by Trial Site.
In all three trials, early sex was reported more often among men who were married or living as married, and among men with more sex partners in the past 12 months and in their lifetimes (). Early sex was not associated with earlier age at first intercourse, but was more likely among men with longer duration of sexual activity, although this was not statistically significant in the Rakai trial.
Number and Percent of Men Reporting Sex Less than 42 Days After Circumcision by Socio-Demographic and Sexual Behavior Characterization at Baseline by Trial Site.
HIV seroconversions at 3 months by early resumption of sexual activity: Kisumu and Orange Farm trials
At the 3 month follow-up visit, there were 3 HIV seroconversions among 1,266 Kisumu participants (). Among 49 participants who reported early sex, there were no seroconversions, while 3 of 1,207 (0.2%) men who did not report early sex seroconverted (p-value > 0.999). There were 7 Kisumu participants who reported having intercourse since circumcision at their scheduled 30-day visit, but the visit date occurred more than 42 days after surgery, so we were unable to determine whether or not this was early sex. None of these men HIV-seroconverted at the 3 month visit. There was one HIV-seroconversion at 3 months among 1,293 Orange Farm participants. Among 289 men who reported early intercourse there was no seroconversion, while one of 995 participants who did not report early intercourse seroconverted (0.1%, p-value > 0.999). Combining data from the Orange Farm and Kisumu trials, the HIV seroprevalence at 3 months follow-up for both trials was 0.0% among men who reported early sex compared to 0.2% among men who did not report early sex after circumcision (p-value > 0.999).
HIV seroconversions at 6 months by early resumption of sexual activity: Kisumu and Rakai trials
Among 1,206 Kisumu participants who did not report early sex, 5 (0.4%) seroconverted by the 6-month follow-up visit, compared to 1 seroconversion among 49 (2.0%) men who reported early sex (). Among 1,008 Rakai participants aged 18–24, there were 8 (0.8%) seroconversions among 951 men who did not report early sex compared to 1 (1.8%) seroconversion among 56 men who reported early sex (). Combined, the seroprevalence at 6 months for 18–24 year-olds in the Kisumu and Rakai trials was 1.9% among men who reported early sex and 0.6% among men who did not report early sex. The combined odds ratio for seroconversion at 6 months for men reporting early sex was 2.99 [95% C.I.: 0.32 to 13.6; p-value = 0.168; ]. If the 7 Kisumu men in whom early sex could not be determined due to visit timing were classified as having early sex, then the combined odds ratio for seroconversion at 6 months for 18–24 year-old Kisumu and Rakai men reporting early sex would have been 2.84 (p-value = 0.181).
Odds Ratio of HIV Seroconversion at 6 Months for Early Resumption of Sex After Circumcision by Trial Site and Combined*.
Among 2,170 Rakai participants aged 15–49, there were 12 (0.6%) HIV seroconversions among 1,193 men who did not report early sex compared to 2 (1.1%) seroconversions among 177 men who reported early sex (p-value = 0.637). Including all Kisumu and Rakai participants, the combined odds ratio for seroconversion at 6 months for men reporting early sex was 2.42 [95% CI: 0.45 to 8.57, p-value = 0.154]. Including the 7 Kisumu men in whom early sex could not be determined due to visit timing as having early sex resulted in a combined odds ratio for seroconversion at 6 months for men reporting early sex would of 2.35 (p-value = 0.163).
Circumcision wound healing and HIV seroconversion at 3 and 6 months
Among Kisumu participants, 16 (1.3%) men did not have complete wound healing at the 30-day visit. One (6.3%) of these 16 men seroconverted at 3 months while there were 2 (0.2%) seroconversions among 1,247 men with complete wound healing at the 30-day visit (p-value = 0.075). One of the 16 men with incomplete healing reported having early sex, but this was not the participant who seroconverted. The 30-day follow-up visit and wound assessment for the participant who seroconverted occurred at 24 days post-circumcision, and he reported having no sex partners since circumcision. At the 6-month visit, there was still only one seroconversion among the 16 men who did not have complete wound healing at the 30-day visit, while there were 5 (0.4%) seroconversions among 1,246 men who had clinically documented complete wound healing (p-value = 0.145).
Among 18–24 year-old Rakai trial participants, 122 (11.4%) men did not have complete wound healing at the 4-week visit. Of these men, 112 had HIV test results available at 6 months, and none seroconverted. This did not differ from seroconversions among men with complete wound healing (9/888 [1.0%]; p-value =0.684). Two (1.6%) of the 122 men with incomplete wound healing reported early sex. Among 15–49 year-old Rakai participants, 318 (13.9%) men did not have complete wound healing at the 4-week visit. Of these men, 302 had HIV test results available at 6 months and 2 (0.7%) seroconverted. This did not differ from seroconversions among men with complete wound healing (12/1,869 [0.6%]; p-value > 0.999). Fifteen (5.0%) of the 302 men with incomplete wound healing reported early sex; none of these men seroconverted.