Guidelines recommend screening for and at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for and on the incidence of these infections in MSM and transgender women taking PrEP. A multicentre, randomised, controlled trial of 3 × 3 screening for and versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. and was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of and infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with , , and is completed. Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of and was 0·155 cases per 100 person-days (95% CI 0·128–0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171–0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068–1·627). Participants in the non-screening arm had a higher incidence of infections and symptomatic infections. There were no significant differences in infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported. We failed to show that non-screening for and is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of . Further research is needed to assess the benefits and harms of and screening in this population. Belgian Health Care Knowledge Centre.

中文翻译：

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淋病奈瑟菌和沙眼衣原体筛查对接受 HIV 暴露前预防的男男性行为者和跨性别女性感染发生率的影响（Gonoscreen 研究）：随机、多中心对照试验的结果

指南建议对男男性行为者 (MSM) 和接受 HIV 暴露前预防 (PrEP) 的变性女性每 3 个月 (3 × 3) 进行一次三个解剖部位（尿道、肛门和咽部）的筛查。我们提出了第一个随机对照试验，以比较筛查与非筛查对接受 PrEP 的 MSM 和跨性别女性这些感染的影响以及对这些感染发生率的影响。在比利时五个 HIV 参考中心，针对接受 PrEP 的 MSM 和跨性别女性进行了一项多中心、随机、对照试验，对筛查和非筛查进行了 3 × 3 筛查。参与者每季度到访 PrEP 诊所，持续 12 个月。并在每次就诊时对双臂进行测试，但如果无症状，则不会向非筛查臂提供结果。主要结局是在每个方案人群中评估的各组的发病率和感染率。如果发病率比 (IRR) 的 95% CI 上限低于 1·25，则证明非筛查组的非劣效性。该试验已在 、 、 注册，并已完成。 2020年9月21日至2021年6月4日期间，506名参与者被随机分配到3×3筛查组，508名参与者被随机分配到非筛查组。 3 × 3 筛查组中的总体发病率为每 100 人日 0·155 例（95% CI 0·128–0·186），而 3 × 3 筛查组中的总体发病率为 0·205 例（95% CI 0·171–0·246） ）在非筛选臂中。非筛查组的发病率显着较高（IRR 1·318，95% CI 1·068–1·627）。非筛查组的参与者感染和症状感染的发生率较高。感染情况没有显着差异。非筛查组的参与者消耗的抗菌药物明显较少。没有报告严重不良事件。我们未能证明，在比利时接受 PrEP 的 MSM 和跨性别女性中，不进行筛查且不劣于 3 × 3 筛查。然而，筛查与较高的抗生素消耗量相关，并且对 的发病率没有影响。需要进一步的研究来评估该人群的益处和危害以及筛查。比利时医疗保健知识中心。