BACKGROUND: Meta-analyses and systematic reviews of observational studies suggest that voluntary medical male circumcision (VMMC) may reduce the risk of HIV acquisition among men who have sex with men (MSM), especially in men who primarily engage in insertive anal sex. We conducted a randomized controlled trial (RCT) to assess the efficacy of VMMC in reducing incident HIV acquisition among MSM.
METHODS: This RCT was conducted in eight cities in China. Uncircumcised, HIV-negative men aged 18-49 years who predominantly practiced insertive anal sex and had two or more male sex partners in the past 6 months, were randomized to either intervention (immediate circumcision) or control (delayed circumcision) arms. HIV testing was repeated at 3, 6, 9, and 12 months. HIV incidence was estimated in intention-to-treat (ITT) and per protocol (PP) analyses. HIV incidence rate ratio (IRR) and 95% confidence intervals (CIs) were calculated. This trial was registered at (ChiCTR2000039436).
RESULTS: A total of 247 MSM were enrolled: 124 in the intervention arm and 123 in the control arm. Baseline characteristics of participants in the intervention and control groups were comparable. Retention rates in both arms were similar during follow-up. The two arms contributed 116 and 117 person-years of follow-up, respectively. Zero and five HIV seroconversion cases were observed in the intervention (HIV incidence rate, per 100 person-years: 0.00, 95% CI:0.00–3.18) and control (4.27, 1.38–9.97) arms. IRR was 0.00 (95% CI: 0.00–1.08) and 0.00 (0.00–1.13) in the ITT and PP analyses. All adverse events related to VMMC were mild and resolved quickly. Follow-up is ongoing and the final results will be available by July 2023.
CONCLUSIONS: This is the first RCT to demonstrate the efficacy of VMMC in preventing HIV among MSM. VMMC is very likely to be efficacious in preventing incident HIV acquisition among MSM who predominantly practice insertive anal sex. Large-scale RCTs with long-term follow-up may be necessary to further confirm this efficacy.

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