Department of Clinical Sciences, HIV/STI Reference Laboratory, Institute of Tropical Medicine, Antwerp, Belgium.
Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
BMJ Open. 2019 Apr 3;9(4):e028145. doi: 10.1136/bmjopen-2018-028145.
Pre-exposure prophylaxis (PrEP) users are screened bi-annual for sexually transmitted infections (STIs). A novel device, called the Colli-Pee, collects first-void urine in a standardised way and the collector tube can be easily delivered by regular post to a certified laboratory. The aim of the study was a one-to-one comparison between the STI test results obtained with the urine collected in the clinic, versus urine collected at home in a real-life setting by Men who have Sex with Men (MSM) in Belgium. The user-friendliness and acceptability of the Colli-Pee device by the users was also evaluated.
A single-site nested substudy in a prospective PrEP demonstration project (Be-PrEP-ared) among MSM in Belgium.
A total of 473 home-based samples from 213 MSM were received with a mean age of 38.5 years.
Participants were requested to collect a urine sample at home using the Colli-Pee device and to send it to the laboratory via regular mail.
The presence of (CT) (NG) (MG) and (TV) was determined using molecular amplification assays. Agreement between test results of samples collected at the clinic and collected at home were evaluated using Cohen's kappa statistic.
TV was not detected. A very good to almost perfect agreement was found for CT, NG and MG of κ=0.75, 0.87 and 0.85, respectively. Using the Colli-Pee device only one low positive CT and two MG infections were missed, however, three additional CT, two NG and six MG infections were detected.
The Colli-Pee device is a feasible and convenient way to collect urine at home for STI testing. This may be particularly relevant for populations that need frequent STI testing, such as PrEP users and patients who prefer home-sampling.
NCT02552914; Pre-results.
暴露前预防（PrEP）使用者每半年接受一次性传播感染（STI）筛查。一种名为 Colli-Pee 的新型装置以标准化的方式收集首次尿液，收集器管可以通过普通邮件轻松送到认证实验室。本研究的目的是比较比利时男男性行为者（MSM）在诊所采集的尿液与在真实环境中在家采集的尿液的 STI 检测结果。同时还评估了 Colli-Pee 装置对使用者的易用性和可接受性。
在比利时 MSM 中进行的前瞻性 PrEP 示范项目（Be-PrEP-ared）中的一个单站点嵌套子研究。
共收到来自 213 名 MSM 的 473 份家庭样本，平均年龄为 38.5 岁。
要求参与者使用 Colli-Pee 装置在家中采集尿液样本，并通过普通邮件将其寄送至实验室。
使用分子扩增检测法确定 （CT）（NG）（MG）和 （TV）的存在。使用 Cohen's kappa 统计评估在诊所采集的样本和在家采集的样本的检测结果之间的一致性。
未检测到 TV。CT、NG 和 MG 的一致性非常好到几乎完美，κ 值分别为 0.75、0.87 和 0.85。仅使用 Colli-Pee 装置漏检了一例低水平阳性 CT 和两例 MG 感染，但检测到三例额外的 CT、两例 NG 和六例 MG 感染。
Colli-Pee 装置是一种在家中采集尿液进行 STI 检测的可行且方便的方法。对于需要频繁进行 STI 检测的人群，例如 PrEP 使用者和更喜欢在家采样的患者，这可能特别相关。
NCT02552914；预注册结果。
