• Ann. Intern. Med. · Jun 2024

    Randomized Controlled Trial Multicenter Study

    Efficacy of Voluntary Medical Male Circumcision to Prevent HIV Infection Among Men Who Have Sex With Men : A Randomized Controlled Trial.

    • Yanxiao Gao, Yuewei Zhan, Yinghui Sun, Weiran Zheng, Weijie Zhang, Leiwen Fu, Zhihui Guo, Yi-Fan Lin, Yuwei Li, Lingling Zheng, Yiqiang Zhan, Zhiqiang Zhu, Junyi Duan, Guanghui Zhang, Tao Huang, Bin Su, Maohe Yu, Guohui Wu, Lin Ouyang, Jin Zhao, Guanghui Wang, Yepeng Zhou, Han-Zhu Qian, Thomas Fitzpatrick, Sten H Vermund, and Huachun Zou.
    • Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, and School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China (Y.G.).
    • Ann. Intern. Med. 2024 Jun 1; 177 (6): 719728719-728.

    BackgroundObservational studies suggest that voluntary medical male circumcision (VMMC) may lower HIV risk among men who have sex with men (MSM). A randomized controlled trial (RCT) is needed to confirm this.ObjectiveTo assess the efficacy of VMMC in preventing incident HIV infection among MSM.DesignAn RCT with up to 12 months of follow-up. (Chinese Clinical Trial Registry: ChiCTR2000039436).Setting8 cities in China.ParticipantsUncircumcised, HIV-seronegative men aged 18 to 49 years who self-reported predominantly practicing insertive anal intercourse and had 2 or more male sex partners in the past 6 months.InterventionVMMC.MeasurementsRapid testing for HIV was done at baseline and at 3, 6, 9, and 12 months. Behavioral questionnaires and other tests for sexually transmitted infections were done at baseline, 6 months, and 12 months. The primary outcome was HIV seroconversion using an intention-to-treat analysis.ResultsThe study enrolled 124 men in the intervention group and 123 in the control group, who contributed 120.7 and 123.1 person-years of observation, respectively. There were 0 seroconversions in the intervention group (0 infections [95% CI, 0.0 to 3.1 infections] per 100 person-years) and 5 seroconversions in the control group (4.1 infections [CI, 1.3 to 9.5 infections] per 100 person-years). The HIV hazard ratio was 0.09 (CI, 0.00 to 0.81; P = 0.029), and the HIV incidence was lower in the intervention group (log-rank P = 0.025). The incidence rates of syphilis, herpes simplex virus type 2, and penile human papillomavirus were not statistically significantly different between the 2 groups. There was no evidence of HIV risk compensation.LimitationFew HIV seroconversions and limited follow-up period.ConclusionAmong MSM who predominantly practice insertive anal intercourse, VMMC is efficacious in preventing incident HIV infection; MSM should be included in VMMC guidelines.Primary Funding SourceThe National Science and Technology Major Project of China.

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