A RANDOMIZED, CONTROLLED TRIAL OF MALE CIRCUMCISION (MC) TO PREVENT HIV INFECTION IN KISUMU, KENYA

S Moses¹, RC Bailey², K Agot³, I Maclean¹, AR Ronald¹, JO Ndinya-Achola^4
1University of Manitoba, Winnipeg, Manitoba; ²University of Chicago at Illinois, Chicago, Illinois; ³Moi University, Eldoret, Kenya; ⁴University of Nairobi, Nairobi, Kenya

Background: Observational studies have shown an association between lack of MC and risk for HIV infection, but randomized controlled trials (RCTs) are necessary to address methodological limitations inherent in such studies. The objectives of this RCT are to assess the effectiveness of MC in reducing HIV incidence, evaluate adverse clinical effects of the MC procedure, and assess differences in subsequent sexual behaviour between circumcised and uncircumcised men.
Methods: Uncircumcised men aged 18-24 years will be identified from STD clinics, workplaces and community organizations. Seronegative men will be asked to give informed consent for enrolment. Circumcision will be performed on men randomized to the treatment arm, and they will be checked for surgical complications 3 days, 8 days and one month after the procedure. They will be counselled to abstain from sex until healing is complete (one month). All participants will be interviewed to assess sexual behaviour and tested for HIV at baseline, and at 1, 3, 6, 12, 18 and 24 months after randomization. They will be tested for STDs at 6-month intervals, and will be counselled on HIV risk reduction measures and provided with condoms. Assuming a 2.5% annual incidence in the control arm, 15% loss to follow-up and 5% cross-over in each direction, approximately 1,400 men will be required in each arm to detect a 50% reduction in the two-year HIV incidence in the MC arm.
Results: Ethical approvals were received in 2001, and participant recruitment and randomization will begin in January 2002. Results from the initial 3 months of recruitment will be presented.
Conclusion: This trial should provide definitive evidence as to the effectiveness of male circumcision as an HIV prevention measure, and the risk, at least in a research setting, of complications of the MC procedure as well as potential adverse behavioural outcomes.