Evaluating STI screening and antimicrobial resistance in Neisseria gonorrhoeae among PrEP users in Vietnam

项目摘要 男男性行为者(MSM)感染艾滋病毒和性传播感染(STI)的风险更高 增加艾滋病毒风险的疾病，如淋球菌和沙眼衣原体。HIV暴露前 预防(PrEP)使用者--其中许多是男男性接触者--也面临着更高的性传播感染风险。美国指导方针 建议PrEP使用者在多个解剖部位(咽部、泌尿生殖器、 和直肠)用于无症状感染。然而，中低收入国家(LMIC)缺乏这种能力 指南，导致LMIC PrEP使用者错失性传播感染筛查和治疗的机会。 淋球菌的抗菌素耐药性(AMR)是一个紧迫的全球健康威胁，其流行率是 在LMIC中最高，那里获得诊断的机会有限。特别是西太平洋地区，它 包括越南的LMIC在内，AMR在淋病奈瑟菌中的传播不断增加，这种病毒已经传播 全世界。在LMICs中淋病奈瑟菌AMR的驱动因素的理解上存在很大的差距。 在这项研究中，来自加州大学洛杉矶分校和河内医科大学的调查人员将调查 在男男性接触者和HIV感染者中筛查沙眼衣原体和淋球菌的可行性 越南河内的预科项目。我们假设筛查是可以接受和可行的。我们还将 淋病奈瑟菌与淋病奈瑟菌共栖感染的危险因素及基因组关系的研究 在与AMR相关的遗传基因座上，假设最近使用抗生素是AMR的风险因素。 目的1：(A)了解沙眼衣原体在肛门、直肠、咽部和泌尿生殖道的分布情况。 越南河内男男性接触者和变性女性PrEP使用者中的淋病感染(n=1300)和(B) 评估快速三点检测的可接受性和可行性，包括支付意愿。 目的2：(A)收集、培养淋病奈瑟菌和口咽部细菌并进行药敏试验 奈瑟氏菌调查AMR和b)进行全基因组检测的患病率和相关性 从同一个体体内分离的一对淋球菌和奈瑟氏菌的序列分析 研究淋病奈瑟菌耐药相关基因之间的关系。 这个为期两年的项目分为四个阶段。第一阶段将持续三个月，将涉及研究的发展 材料、计划和培训。第二阶段将持续一年，将评估C。 沙眼衣原体和淋病奈瑟菌的筛选。第三阶段将持续9个月，将涉及抗菌药 药敏试验和全基因组测序。第四阶段将持续3个月，将涉及传播 通过手稿、演示文稿以及与当地政府和卫生机构共享数据来了解研究结果。 这项研究的结果将成为未来R01-调查例行程序影响的建议的基础 STI的筛选和治疗对发展耐药淋球菌的影响。

PROJECT ABSTRACT Men who have sex with men (MSM) are at higher risk for HIV and sexually transmitted infections (STIs) that increase HIV risk, such as Neisseria gonorrhoeae and Chlamydia trachomatis. HIV pre-exposure prophylaxis (PrEP) users—many of whom are MSM—are also at increased risk for STIs. U.S. guidelines recommend that PrEP users undergo frequent screening in multiple anatomic sites (pharyngeal, urogenital, and rectal) for asymptomatic infections. However, lower- and middle-income countries (LMICs) lack such guidelines, resulting in missed opportunities for STI screening and treatment among LMIC PrEP users. Antimicrobial resistance (AMR) in N. gonorrhoeae is an urgent global health threat and the prevalence is highest in LMICs, where access to diagnostics is limited. In particular, the Western Pacific Region, which includes the LMIC of Vietnam, has seen increasing spread of AMR in N. gonorrhoeae, which has spread worldwide. Major gaps exist in understanding the drivers of AMR in N. gonorrhoeae in LMICs. In this study, investigators from UCLA and Hanoi Medical University will investigate the acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening among MSM and transwomen engaged in an HIV PrEP program in Hanoi, Vietnam. We hypothesize that screening will be acceptable and feasible. We will also investigate risk factors for AMR and genomic relationships between commensal Neisseria and N. gonorrhoeae at genetic loci associated with AMR, hypothesizing that recent antibiotic use is a risk factor for AMR. AIM 1: (a) To determine the distribution of anorectal, pharyngeal, and urogenital C. trachomatis and N. gonorrhoeae infections among MSM and transgender women PrEP users (n=1,300) in Hanoi, Vietnam and (b) To evaluate the acceptability and feasibility, including willingness to pay, of rapid, triple-site testing. AIM 2: (a) To collect, culture, and perform antibiotic susceptibility testing on N. gonorrhoeae and oropharyngeal Neisseria species to investigate the prevalence and correlates of AMR and b) To perform whole-genome sequencing on pairs of N. gonorrhoeae and Neisseria species isolated from within the same individual to investigate relationships within genes associated with antimicrobial resistance in N. gonorrhoeae. This two-year project has four phases. Phase 1 will last three months and will involve development of study materials, planning, and training. Phase 2 will last one year and will evaluate acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening. Phase 3 will last 9 months and will involve antimicrobial susceptibility testing and whole genome sequencing. Phase 4 will last 3 months and will involve dissemination of findings through manuscripts, presentations, and sharing of data with local government and health agencies. Findings from the study will form the foundation for a future R01-proposal to investigate the impact of routine screening and treatment of STIs on the development of antimicrobial resistance is N. gonorrhoeae.