Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059371
Status:
COMPLETED
Last Update Posted:
2008-05-30
First Post:
2003-04-23
Brief Title:
Male Circumcision and HIV Rates in Kenya
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Trial of Male Circumcision to Reduce HIV Incidence
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None