Clinical trial NCT00059371: Male Circumcision and HIV Rates in Kenya
Official title: Trial of Male Circumcision to Reduce HIV Incidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Male circumcision
HIV acquisition
Sexually transmitted infection
HIV Seronegativity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-04-24
Enrollment: 2887
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria

* HIV uninfected and willing to be tested
* Live in Kisumu District, Kenya
* Uncircumcised but willing to be circumcised
* At least one sexual partner in the 12 months prior to study entry

Primary outcomes:
measure: HIV incidence
timeFrame: 2 years
measure: surgical complications
timeFrame: 2 years
Secondary outcomes:
measure: incidence of other sexually transmitted diseases
timeFrame: 2 years
measure: behavioral risks
timeFrame: 2 years
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: UNIM Clinic
Study officials:
affiliation: University of Illinois at Chicago
name: Robert C. Bailey, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis SM, Pals S, Yang C, Odoyo-June E, Chang J, Walters MS, Jaoko W, Bock N, Westerman L, Toledo C, Bailey RC. Circumcision status at HIV infection is not associated with plasma viral load in men: analysis of specimens from a randomized controlled trial. BMC Infect Dis. 2018 Jul 28;18(1):350. doi: 10.1186/s12879-018-3257-8.
citation: Mehta SD, Gaydos C, Maclean I, Odoyo-June E, Moses S, Agunda L, Quinn N, Bailey RC. The effect of medical male circumcision on urogenital Mycoplasma genitalium among men in Kisumu, Kenya. Sex Transm Dis. 2012 Apr;39(4):276-80. doi: 10.1097/OLQ.0b013e318240189c.
citation: Mehta SD, Maclean I, Ndinya-Achola JO, Moses S, Martin I, Ronald A, Agunda L, Murugu R, Bailey RC, Melendez J, Zenilman JM. Emergence of quinolone resistance and cephalosporin MIC creep in Neisseria gonorrhoeae isolates from a cohort of young men in Kisumu, Kenya, 2002 to 2009. Antimicrob Agents Chemother. 2011 Aug;55(8):3882-8. doi: 10.1128/AAC.00155-11. Epub 2011 May 23.
citation: Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, Taljaard D, Puren A, Agot K, Serwadda D, Parker CB, Wawer MJ, Bailey RC. Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS. 2009 Jul 31;23(12):1557-64. doi: 10.1097/QAD.0b013e32832afe95.
citation: Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.