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      Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial

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          Abstract

          Background

          Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis.

          Methods and Findings

          A total of 3,274 uncircumcised men, aged 18–24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR) of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 − RR. The trial was stopped at the interim analysis, and the mean (interquartile range) follow-up was 18.1 mo (13.0–21.0) when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years) in the intervention group and 49 (2.1 per 100 person-years) in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%–0.68%; p < 0.001). This RR corresponds to a protection of 60% (95% CI: 32%–76%). When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%–77%).

          Conclusion

          Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil.)

          Abstract

          The first trial of male circumcision for reducing the risk of HIV finds significantly lower new cases in the treatment group.

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          Most cited references33

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          Male circumcision and risk of HIV infection in sub-Saharan Africa: a systematic review and meta-analysis.

          Kathleen Quigley, William Weiss, Keith R. Hayes (2000)
          To systematically review studies of male circumcision and the risk of HIV-1 infection in men in sub-Saharan Africa, and to summarize the findings in a meta-analysis. A meta-analysis of observational studies. A systematic literature review was carried out of studies published up to April 1999 that included circumcision as a risk factor for HIV-1 infection among men in sub-Saharan Africa. A random effects meta-analysis was used to calculate a pooled relative risk (RR) and 95% confidence interval (CI) for all studies combined, and stratified by type of study population. Further analyses were conducted among those studies that adjusted for potential confounding factors. Twenty-seven studies were included. Of these, 21 showed a reduced risk of HIV among circumcised men, being approximately half that in uncircumcised men (crude RR = 0.52, CI 0.40-0.68). In 15 studies that adjusted for potential confounding factors, the association was even stronger (adjusted RR = 0.42, CI 0.34-0.54). The association was stronger among men at high risk of HIV (crude RR = 0.27; adjusted RR = 0.29, CI 0.20-0.41) than among men in general populations (crude RR = 0.93; adjusted RR = 0.56, CI 0.44-0.70). Male circumcision is associated with a significantly reduced risk of HIV infection among men in sub-Saharan Africa, particularly those at high risk of HIV. These results suggest that consideration should be given to the acceptability and feasibility of providing safe services for male circumcision as an additional HIV prevention strategy in areas of Africa where men are not traditionally circumcised.
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            Female to male transmission of human immunodeficiency virus type 1: risk factors for seroconversion in men.

            Liam R. Brunham, John Ronald, L D'Costa … (1989)
            To determine the frequency and risk factors for female to male sexual transmission of human immunodeficiency virus type 1 (HIV-1), a prospective study was carried out in 422 men who had acquired a sexually transmitted disease (STD) from a group of prostitutes with a prevalence of HIV-1 infection of 85%. The initial seroprevalence of HIV among the men was 12%. 24 of 293 (8.2%) initially seronegative men seroconverted to HIV-1. Newly acquired infection was independently associated with frequent prostitute contact (risk ratio 3.2, 95% confidence interval 1.2-8.1), with the acquisition of genital ulcer disease (risk ratio 4.7, 95% confidence interval 1.3-17.0), and with being uncircumcised (risk ratio 8.2, 95% confidence interval 3.0-23.0). 96% of documented seroconversions occurred in men with one or both of the latter two risk factors. In a subgroup of 73 seronegative men who reported a single prostitute sexual contact, the frequency of HIV-1 infection was 8.2% during 12 weeks of observation. No man without a genital ulcer seroconverted. A cumulative 43% of uncircumcised men who acquired an ulcer seroconverted to HIV-1 after a single sexual exposure. These data indicate an extremely high rate of female to male transmission of HIV-1 in the presence of STD and confirm a causal relation between lack of male circumcision, genital ulcer disease, and susceptibility to HIV-1 infection.
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              Ecological and individual level analysis of risk factors for HIV infection in four urban populations in sub-Saharan Africa with different levels of HIV infection.

              M Laourou, E Lagarde, L Morison … (2001)
              To identify factors that could explain differences in rate of spread of HIV between different regions in sub-Saharan Africa. Cross-sectional study. The study took place in two cities with a relatively low HIV prevalence (Cotonou, Benin and Yaoundé, Cameroon), and two cities with a high HIV prevalence (Kisumu, Kenya and Ndola, Zambia). In each of these cities, a representative sample was taken of about 1000 men and 1000 women aged 15-49 years. Consenting men and women were interviewed about their socio-demographic background and sexual behaviour; and were tested for HIV, herpes simplex virus type 2 (HSV-2), syphilis, Chlamydia trachomatis and Neisseria gonorrhoea infection, and (women only) Trichomonas vaginalis. Analysis of risk factors for HIV infection was carried out for each city and each sex separately. Adjusted odds ratios (aOR) were obtained by multivariate logistic regression. The prevalence of HIV infection in sexually active men was 3.9% in Cotonou, 4.4% in Yaoundé, 21.1% in Kisumu, and 25.4% in Ndola. For women, the corresponding figures were 4.0, 8.4, 31.6 and 35.1%. High-risk sexual behaviour was not more common in the high HIV prevalence cities than in the low HIV prevalence cities, but HSV-2 infection and lack of circumcision were consistently more prevalent in the high HIV prevalence cities than in the low HIV prevalence cities. In multivariate analysis, the association between HIV infection and sexual behavioural factors was variable across the four cities. Syphilis was associated with HIV infection in Ndola in men [aOR = 2.7, 95% confidence interval (CI) = 1.5-4.91 and in women (aOR = 1.7, 95% CI = 1.1-2.6). HSV-2 infection was strongly associated with HIV infection in all four cities and in both sexes (aOR ranging between 4.4 and 8.0). Circumcision had a strong protective effect against the acquisition of HIV by men in Kisumu (aOR = 0.25, 95% CI = 0.12-0.52). In Ndola, no association was found between circumcision and HIV infection but sample sizes were too small to fully adjust for confounding. The strong association between HIV and HSV-2 and male circumcision, and the distribution of the risk factors, led us to conclude that differences in efficiency of HIV transmission as mediated by biological factors outweigh differences in sexual behaviour in explaining the variation in rate of spread of HIV between the four cities.
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                Author and article information

                Contributors
                : Role: Academic Editor
                Journal
                Journal ID (nlm-ta): PLoS Med
                Journal ID (publisher-id): pmed
                Title: PLoS Medicine
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Print): 1549-1277
                ISSN (Electronic): 1549-1676
                Publication date (Print): November 2005
                Publication date (Electronic): 25 October 2005
                Volume: 2
                Issue: 11
                Electronic Location Identifier: e298
                Affiliations
                [1] 1Hôpital Ambroise-Paré, Assitance Publique—Hôpitaux de Paris, Boulogne, France,
                [2] 2INSERM U 687, Saint-Maurice, France,
                [3] 3University Versailles Saint-Quentin, Versailles, France,
                [4] 4IFR 69, Villejuif, France,
                [5] 5Progressus, Johannesburg, South Africa,
                [6] 6National Institute for Communicable Disease, Johannesburg, South Africa
                San Francisco General Hospital, San Francisco, California United States of America.
                Author notes
                * To whom correspondence should be addressed. E-mail: bertran.auvert@ 123456apr.aphp.fr

                Competing Interests: The authors have declared that no competing interests exist.

                Author Contributions: BA designed the study with DT, EL, and AP. DT and AP were responsible for operational aspects, including laboratory and field work and in-country administration of the study. BA monitored the study with input from EL and wrote the paper with input from all authors. BA analyzed the data with RS, with inputs from JST. RS conducted the interim analysis.

                Article
                DOI: 10.1371/journal.pmed.0020298
                PMC ID: 1262556
                PubMed ID: 16231970
                SO-VID: bc91342c-b328-4cbe-9f6a-2b5a61509770
                Copyright © Copyright: © 2005 Auvert et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                History
                Date received : 29 June 2005
                Date accepted : 26 September 2005
                Related
                First Trial of Male Circumcision against HIVThe First Randomised Trial of Male Circumcision for Preventing HIV: What Were the Ethical Issues?Does Male Circumcision Prevent HIV Infection?A Landmark Paper in HIV Research?
                Categories
                Subject: Research Article
                Subject: Infectious Diseases
                Subject: Epidemiology/Public Health
                Subject: Health Policy
                Subject: HIV/AIDS
                Subject: Sexual Health
                Subject: Urology
                Subject: Infectious Diseases
                Subject: HIV Infection/AIDS
                Subject: Sexually Transmitted Infections - Other than HIV/AIDS
                Subject: Medicine in Developing Countries

                ScienceOpen disciplines: Medicine
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                ScienceOpen disciplines: Medicine

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