16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

A RANDOMIZED CONTROLLED TRIAL OF MALE CIRCUMCISION TO REDUCE HIV INCIDENCE IN KISUMU, KENYA: PROGRESS TO DATE

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. TuAc0201

R.C. Bailey¹, S. Moses², K. Agot³, C.B. Parker⁴, I. Maclean⁵, J.O. Ndinya-Achola6
¹ University of Illinois at Chicago, Div. of Epidemiology, School of Public Health, Chicago, United States, ² University of Manitoba, Medical Microbiology, Winnipeg, Canada, ³ UNIM Project, Kisumu, Kenya, ⁴ Research Triangle Institute International, Research Triangle, United States, ⁵ University of Manitoba, Medeical Microbiology, Winnipeg, Canada, ⁶ University of Nairobi, Medical Microbiology, Nairobi, Kenya

BACKGROUND: Many observational studies and one clinical trial have shown a protective effect of male circumcision (MC) against HIV acquisition. We report progress from a randomized controlled trial (RCT) of MC to assess reduction in HIV incidence, safety, and behavioral disinhibition in Kisumu District, Kenya.

METHODS: Sexually active 18 – 24 year-old men are counselled and tested for HIV. Seronegative consenting men are randomized equally to treatment (circumcision) and control (non-circumcision) arms. The circumcised men are examined 3 and 8 days after surgery. Men in both arms are counseled and tested for HIV at 1 and 3 months after enrollment and are followed at 6, 12, 18 and 24 months with additional HIV testing, STI testing and treatment, and behavioral risk assessment. Men who are positive at screening or seroconvert are referred to a post-test support group offering care and treatment. The sample size of 2784 is designed to detect a 50% reduction in HIV incidence.

RESULTS: Of 6686 men screened, 2784 (42%) were randomized, 1391 to MC, of whom 1334 (95.9%) completed the procedure. 11 (0.8%) of controls were circumcised off protocol. As of January 15, 2006, 744 men (86% of expected number) had completed 24 months of follow-up. Total follow-up was 3146 person-years (PY), and 54 HIV seroconversions had occurred. There were 24 adverse events among 23 men (1.7%) considered related to the MC procedure, mainly post-operative bleeding or infection, none severe, and they resolved quickly without sequellae. Incidences of gonorrhea and chlamydia infection were 4.5 and 4.7 per 100 PYs, respectively.

CONCLUSIONS: Recruitment was completed September 2005. Final results will be available 24 months thereafter. An interim analysis will be presented to the DSMB in June 2006. The investigators are blinded to study arm, but overall HIV incidence and loss-to-follow-up are consistent with our original assumptions, and rates of cross-over are less than expected.

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2006-08-13
TuAc0201

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