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拉丁美洲男男性行为者和跨性别女性使用口服暴露前预防药物(ImPrEP)的细菌性性传播感染:一项前瞻性、开放标签、多中心研究的二次分析

Bacterial sexually transmitted infections among men who have sex with men and transgender women using oral pre-exposure prophylaxis in Latin America (ImPrEP): a secondary analysis of a prospective, open-label, multicentre study.

作者信息

Torres Silva Mayara Secco, Torres Thiago Silva, Coutinho Carolina, Ismério Moreira Ronaldo, da Costa Leite Iuri, Cunha Marcelo, da Costa Leite Pedro Henrique Amparo, Cáceres Carlos F, Vega-Ramírez Hamid, Konda Kelika A, Guanira Juan, Valdez Madruga José, Wagner Cardoso Sandra, Benedetti Marcos, Pimenta Maria Cristina, Hoagland Brenda, Grinsztejn Beatriz, Gonçalves Veloso Valdilea

机构信息

Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (INI-Fiocruz), Rio de Janeiro, Brazil.

Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz (ENSP-Fiocruz), Rio de Janeiro, Brazil.

出版信息

Lancet HIV. 2024 Oct;11(10):e670-e679. doi: 10.1016/S2352-3018(24)00211-X. Epub 2024 Sep 5.

DOI:10.1016/S2352-3018(24)00211-X
PMID:39243787
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11442320/
Abstract

BACKGROUND

The global burden of sexually transmitted infections (STIs) poses a challenge in the context of HIV pre-exposure prophylaxis (PrEP) programmes. We aimed to explore factors associated with prevalent, incident, and recurrent STIs in men who have sex with men (MSM) and transgender women on PrEP in Brazil, Mexico, and Peru.

METHODS

ImPrEP was a prospective, single-arm, open-label, multicentre study that enrolled MSM and transgender women in the context of the public health systems of Brazil (14 sites), Mexico (four sites), and Peru (ten sites) between February, 2018, and June, 2021. Eligibility criteria followed regional PrEP guidelines at the study start, including participants aged 18 years and older, not living with HIV, and reporting at least one of the following in the previous 6 months: condomless anal sex (CAS), anal sex with partner(s) living with HIV, any bacterial STI, or transactional sex. Eligible participants were screened and enrolled on the same day to receive daily oral PrEP (tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg). We assessed three outcomes: prevalent bacterial STIs, incident bacterial STIs, and recurrent bacterial STIs. Testing occurred at baseline and quarterly for syphilis, anorectal chlamydia, and anorectal gonorrhoea. Behavioural data were collected at baseline and quarterly. The study was registered with the Brazilian Registry of Clinical Trials, U1111-1217-6021.

FINDINGS

Among all 9509 participants included in the ImPrEP study (3928 [41·3%] in Brazil, 3288 [34·6%] in Mexico, and 2293 [24·1%] in Peru), 8525 (89·7%) had available STI results at baseline and were included in the prevalent STI analysis, and 7558 (79·5%) had available STI results during follow-up and were included in the incident and recurrent STI analyses. 2184 (25·6%) of 8525 participants had any bacterial STI at baseline. STI incidence during follow-up was 31·7 cases per 100 person-years (95% CI 30·7-32·7), with the highest rate for anorectal chlamydia (11·6 cases per 100 person-years, 95% CI 11·0-12·2), followed by syphilis (10·5 cases per 100 person-years, 9·9-11·1) and anorectal gonorrhoea (9·7 cases per 100 person-years, 9·2-10·3). Although only 2391 (31·6%) of 7558 participants had at least one STI during follow-up, 915 (12·1%) participants had recurrent diagnoses, representing 2328 (61·2%) of 3804 incident STI diagnoses. Characteristics associated with prevalent, incident, and recurrent STIs included younger age, multiple sex partners, receptive CAS, substance use, and previous STI diagnoses at baseline (incident or recurrent only).

INTERPRETATION

Our findings underscore the nuanced dynamics of STI transmission among MSM and transgender women across Latin America, highlighting an urgent need for tailored interventions to mitigate STI burden effectively, especially among the most susceptible individuals.

FUNDING

Unitaid, WHO, and ministries of health (Brazil, Mexico, and Peru).

TRANSLATIONS

For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.

摘要

背景

在艾滋病病毒暴露前预防(PrEP)项目背景下,性传播感染(STIs)的全球负担构成了一项挑战。我们旨在探讨巴西、墨西哥和秘鲁接受PrEP的男男性行为者(MSM)和跨性别女性中,与STIs流行、新发和复发相关的因素。

方法

ImPrEP是一项前瞻性、单臂、开放标签的多中心研究,于2018年2月至2021年6月期间,在巴西(14个地点)、墨西哥(4个地点)和秘鲁(10个地点)的公共卫生系统中招募MSM和跨性别女性。研究开始时,纳入标准遵循区域PrEP指南,包括年龄在18岁及以上、未感染艾滋病毒,且在过去6个月内报告至少以下情况之一:无保护肛交(CAS)、与感染艾滋病毒的伴侣进行肛交、任何细菌性STI或交易性性行为。符合条件的参与者在同一天进行筛查并登记,以接受每日口服PrEP(替诺福韦酯300毫克和恩曲他滨200毫克)。我们评估了三个结果:细菌性STIs流行情况、细菌性STIs新发情况和细菌性STIs复发情况。在基线和每季度对梅毒、肛门衣原体和肛门淋病进行检测。行为数据在基线和每季度收集一次。该研究已在巴西临床试验注册中心注册,注册号为U1111-1217-6021。

结果

在ImPrEP研究纳入的所有9509名参与者中(巴西3928名[41.3%],墨西哥3288名[34.6%],秘鲁2293名[24.1%]),8525名(89.7%)在基线时有可用的STI检测结果,并纳入了STIs流行情况分析,7558名(79.5%)在随访期间有可用的STI检测结果,并纳入了STIs新发和复发情况分析。8525名参与者中有2184名(25.6%)在基线时有任何细菌性STI。随访期间STI发病率为每100人年31.7例(95%CI 30.7-32.7),其中肛门衣原体发病率最高(每100人年11.6例,95%CI 11.0-12.2),其次是梅毒(每100人年10.5例,9.9-11.1)和肛门淋病(每100人年9.7例,9.2-10.3)。虽然在7558名参与者中,只有2391名(31.6%)在随访期间至少患过一种STI,但有915名(12.1%)参与者有复发诊断,占3804例新发STI诊断的2328例(61.2%)。与STIs流行、新发和复发相关的特征包括年龄较小、多个性伴侣、接受性CAS、物质使用以及基线时既往STI诊断(仅新发或复发情况)。

解读

我们的研究结果强调了拉丁美洲MSM和跨性别女性中STI传播的细微差别动态,突出了迫切需要采取针对性干预措施,以有效减轻STI负担,特别是在最易感染个体中。

资金来源

国际药品采购机制、世界卫生组织以及巴西、墨西哥和秘鲁的卫生部。

翻译说明

摘要的葡萄牙语和西班牙语翻译见补充材料部分。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc16/11442320/bf4848d75cee/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc16/11442320/bf4848d75cee/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc16/11442320/bf4848d75cee/gr1.jpg

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