Over 40 epidemiological studies and one clinical trial have found a protective effect of male circumcision (MC) against HIV acquisition in men. A meta-analysis of African studies has demonstrated an adjusted reduction in HIV risk of 45% in the general population and 70% among high risk groups. A clinical trial in South Africa demonstrated a 60% protective effect, with a 76% effect in a per-protocol analysis. In addition, uncircumcised men are at higher risk for acquisition of certain sexually transmitted infections (STIs), which in turn increase HIV susceptibility. These data have led to calls for male circumcision to be considered as an HIV prevention strategy, especially in areas of high HIV prevalence. However, at meetings held by UNAIDS, the World Health Organization, UNICEF and others, researchers and policy makers have concluded that clear evidence of a protective effect from additional randomized controlled trials (RCTs) is required before MC can be advocated for HIV prevention. This application seeks support for continuation of a randomized controlled trial of male circumcision in Kisumu, Kenya. The main objective is to assess the effectiveness of MC in reducing HIV incidence in young, sexually active men. Uncircumcised HIV seronegative men aged 18-24 years are randomized into either the treatment (circumcision) or control arm and followed for two years, with regular behavioral and STI assessments, as well as HIV testing and counseling. The primary endpoint is HIV incidence, with surgical complications, STI incidence, and behavioral risk as secondary outcomes. Enrollment of 2784 young men was completed September 2005. This sample size will provide 80% power to detect a 50% reduction in HIV incidence over two years. So far, just 11% of person-years have been missed due to participants not reporting for study visits; rates of HIV and STI incidence are consistent with original projections. Thus the study is on track to meet the original objectives and to provide a clear answer to the question of whether male circumcision reduces HIV incidence. Because any effect of MC could be diluted after 24 months through differential changes in behavior by circumcised versus uncircumcised men, we propose to extend follow-up beyond two years on a sub-cohort of participants. Since MC is little practiced in the high HIV prevalence regions of Africa, the results of this trial could have a very significant impact on the HIV/AIDS pandemic. ? ? ? ?

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
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AIDS Clinical Studies and Epidemiology Study Section (ACE)
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Williams, Carolyn F
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University of Illinois at Chicago
Public Health & Prev Medicine
Schools of Public Health
United States
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Senkomago, Virginia; Backes, Danielle M; Hudgens, Michael G et al. (2016) Higher HPV16 and HPV18 Penile Viral Loads Are Associated With Decreased Human Papillomavirus Clearance in Uncircumcised Kenyan Men. Sex Transm Dis 43:572-8
Senkomago, Virginia; Backes, Danielle M; Hudgens, Michael G et al. (2015) Acquisition and persistence of human papillomavirus 16 (HPV-16) and HPV-18 among men with high-HPV viral load infections in a circumcision trial in Kisumu, Kenya. J Infect Dis 211:811-20
Röhl, Maria; Tjernlund, Annelie; Mehta, Supriya D et al. (2015) Comparable mRNA expression of inflammatory markers but lower claudin-1 mRNA levels in foreskin tissue of HSV-2 seropositive versus seronegative asymptomatic Kenyan young men. BMJ Open 5:e006627
Rositch, Anne F; Mao, Lu; Hudgens, Michael G et al. (2014) Risk of HIV acquisition among circumcised and uncircumcised young men with penile human papillomavirus infection. AIDS 28:745-52
Riess, Thomas H; Achieng', Maryline M; Bailey, Robert C (2014) Women's beliefs about male circumcision, HIV prevention, and sexual behaviors in Kisumu, Kenya. PLoS One 9:e97748
Backes, Danielle M; Snijders, Peter J F; Hudgens, Michael G et al. (2013) Sexual behaviour and less frequent bathing are associated with higher human papillomavirus incidence in a cohort study of uncircumcised Kenyan men. Sex Transm Infect 89:148-55
Mehta, Supriya D; Moses, Stephen; Agot, Kawango et al. (2013) The long-term efficacy of medical male circumcision against HIV acquisition. AIDS 27:2899-907
Mehta, Supriya D; Moses, Stephen; Agot, Kawango et al. (2013) Medical male circumcision and herpes simplex virus 2 acquisition: posttrial surveillance in Kisumu, Kenya. J Infect Dis 208:1869-76
Odoyo-June, Elijah; Rogers, John H; Jaoko, Walter et al. (2013) Changes in plasma viral load and penile viral shedding after circumcision among HIV-positive men in Kisumu, Kenya. J Acquir Immune Defic Syndr 64:511-7
Westercamp, Nelli; Mattson, Christine L; Bailey, Robert C (2013) Measuring prevalence and correlates of concurrent sexual partnerships among young sexually active men in Kisumu, Kenya. AIDS Behav 17:3124-32

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