HIV Infections Clinical Trial
Official title:
Trial of Male Circumcision to Reduce HIV Incidence
The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.
Since 1989, numerous epidemiological studies have reported a significant association between
lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse.
These results have led to calls for male circumcision to be considered as an additional HIV
prevention strategy. However, there is a consensus among the international health community
that a randomized controlled trial of MC is needed to control for possible confounding
factors. Additionally, known risks associated with MC need further investigation. This study
will assess the effectiveness of male circumcision in reducing HIV incidence and will
evaluate complications of the MC procedure, changes in sexual behavior following
circumcision, and the biological mechanisms by which the foreskin may increase HIV
susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the
main ethnic group and less than 10% of adult men are circumcised.
Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and
testing. HIV negative men will be asked to enroll in the study. All study participants will
be interviewed to obtain socio-demographic information and assess behavioral risk factors.
Participants will be examined for significant medical conditions. All men will be counseled
in strategies to reduce their risk for HIV infection. Consenting men will be randomly
assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the
study. After circumcision, men will be monitored for complications. They will be counseled
to abstain from sex until healing is complete. Follow-up visits will occur every 6 months
for 2 years. Uncircumcised men will be offered circumcision at the end of follow-up.
The primary study endpoints will be HIV incidence and surgical complications. Additional
outcomes will be the incidence of other sexually transmitted diseases and behavioral risks.
Additional laboratory studies of foreskin tissue will evaluate the number and density of
specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by
which presence of foreskin may increase HIV susceptibility.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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