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The safety of adult male circumcision in HIV-infected and uninfected men in Rakai, Uganda ( WEAC101 ). Godfrey Kigozi Rakai Health Sciences Program 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention Sydney, Australia July 25 th 2007. Acknowledgement.
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The safety of adult male circumcision in HIV-infected and uninfected men in Rakai, Uganda (WEAC101) Godfrey Kigozi Rakai Health Sciences Program 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention Sydney, Australia July 25th 2007
Acknowledgement • Ron Gray Stephen Watya • Maria Wawer Noah Kiwanuka • David Serwadda Victor Ssempijja • Nehemia Kighoma Fred Wabwire-Mangen • Nelson Sewankambo Fred Makumbi • Fred Nalugoda Kiggundu Valerian • James Nkale Jackson Musuuza • Denis Buwembo Pius Opendi • Joseph Kagaayi Tom Lutalo • Dan Namuguzi • Trial Participants • Funders – Gates and NIH • Rakai Program staff
Objective • To assess the safety of adult male circumcision (MC) by comparing rates of adverse events (AEs) related to circumcision among HIV+ and HIV- men.
Background 1 • 3 RCTs have shown that male circumcision reduces the risk of HIV acquisition in men by 50-60%. • WHO/UNAIDS has recommended MC as an additional strategy for preventing heterosexual HIV infection in men. • The safety of surgery is a paramount consideration in planning future circumcision programs, • to minimize surgical risks and • to provide guidelines for best practices in surgical procedures and postoperative care.
Background 2 • Some information is available on postoperative complications in children and in HIV-negative men (rates range from 2-10%), • However, little information exists on the safety of MC in HIV-infected men. • If surgery was found to be unsafe in HIV+ men, these individuals might have to either • be excluded from programs, which would be potentially stigmatizing, or • they might require specialized services for postoperative care which could add to program costs and complexity.
Methods 1 • Two separate but complementary RCTs of adult MC were conducted in Rakai district, Uganda. • One trial, supported by the NIH, • Enrolled HIV-negative men who agreed to know their HIV status • Was stopped for efficacy on December 12, 2006. • The other trial, supported by Gates Foundation • Enrolled HIV-positive men without AIDs symptoms or CD4 > 350, and HIV-negative who declined to know their HIV status • Enrollment was closed on December 19, 2006.
Methods 2 • In the two trials, 2,326 HIV-negative men and 420 HIV-positive men were circumcised • Circumcision was done by physicians using the sleeve circumcision procedure. • All men who were circumcised • provided written informed consent for surgery, • were strongly advised to refrain from sexual intercourse until the wound was certified to be fully healed, • advised to practice safe sex (ABC) • Post-operative follow up was done by medical health workers, at ~ 1 day, 7 days, and 1 month, • assessed surgery-related adverse events (AEs), wound healing and resumption of intercourse
Methods - 3 • AEs graded as: • Grade 1 (mild), required no treatment • Grade 2 (moderate) • Grade 3 (severe) required medical care/surgical intervention • All surgery related AEs were reviewed and summarized by a medical officer at the time they were reported • Chi-square or Fisher’s exact tests were used to compare AE rates and wound healing between HIV-positive and HIV-negative men • Multiple logistic regression was used to assess factors associated with surgery-related AEs.
Table 1: Characteristics of HIV-positive and HIV-negative men at enrollment-1 HIV+ men were more likely to be married and less educated
Table 2: Characteristics of HIV-positive and HIV-negative men t enrollment - 2 • HIV+ men reported more sexual partners
Table 3: Characteristics of HIV-positive and HIV-negative men - 3 • HIV+ men reported less consistent condom use and had higher rates of STD symptoms.
Table 4: Surgery related adverse events by severity No significant difference in rates of moderate or severe surgery-related AEs between HIV-positive and HIV-negative men (p=0.7).
Table 5: Common cause-specific surgery related adverse events by severity -1 Infections were the most common AEs: the rates of moderate or severe infections were 1.9% in HIV-positive versus 2.3% in HIV-negative men.
Table 6: Common cause-specific surgery related AEs - 2 Rates of mod-severe bleeding/hematoma and wound dehiscence complications were similar in the two groups.
Table 7: Surgery-related adverse events by timing of resumption of intercourse in HIV+ and HIV-negative men - 1 AE rates were higher in men who resumed intercourse before wound healing. But differences were not significant.
Other findings • The proportion of men with completed healing by 30 days post-surgery was lower in HIV-positive (71.2%) than HIV-negative men (80.7%, p <0.0001). • Multiple regression identified no significant sociodemographic, behavioral or STI symptoms predictive of moderate/severe AEs.
Conclusion • Overall,the safety of circumcision was comparable in HIV-positive and HIV-negative men • The rates of moderate or severe AES are acceptably low • Wound healing was somewhat slower among the HIV-infected • Resumption of sex before wound healing was associated with higher complication rates (though not statistically significant)
