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Public Health Targeting of PrEP at HIV Positives' Bridging Networks (SOPHOCLES)

2020年1月6日 更新者:University of Chicago
This developmental research grant award (R21) requests funds to explore the feasibility and impact of a public health system PrEP intervention in a recently emerging HIV epidemic in Athens Greece. The investigators propose a modeling approach using an Agent Based Model (ABM) that moves beyond basic pathogen and transmission patterns to dealing with complex social interactions, including overlapping social and sexual networks as well as implementation realities, like finite PrEP resources, delayed linkage to PrEP care and early PreP care retention based upon empirically collected data in Athens Greece.

研究概览

地位

完全的

详细说明

This developmental research grant award (R21) requests funds to explore the feasibility and impact of a public health system PrEP intervention in a recently emerging HIV epidemic in Athens Greece. As HIV epidemics in most settings globally have plateaued or are in decline, emerging epidemics, re-emerging epidemics or outbreaks will become more common, particularly when social, political or other "shocks" that impact HIV prevention resources occur. One well characterized example is the recent epidemic among people who inject drugs (PWID) that started in Athens following austerity measures in 2010. While some success in limiting the epidemic within PWID has been observed, recent phylogenetic and surveillance analysis demonstrates that the HIV strain from this most recent PWID epidemic (CRF35_AD, CRF14_BG, subtypes A and B) has spilled over into MSM in 2013 (see Preliminary Studies).

In emerging epidemics, oral chemoprophylaxis is a commonly-used public health strategy to prevent infectious diseases in susceptible persons. For example, among US and European MSM, antibiotic prophylaxis for sex-partners in outbreaks of invasive meningococcal disease has limited emerging outbreaks. Similarly, pre-exposure prophylaxis (PrEP) has the potential to be used in emerging epidemics to prevent onwards HIV transmission. While this approach would seem intuitive, current conceptualizations of PrEP implementation narrowly use a clinical model focused on individualized intervention between health provider and client. This is problematic because the public health impact of PrEP may be limited due to lack of proper targeting. In fact, evidence from "real-world" PrEP use suggests that lower risk clients are accessing PrEP. As compared to resource intensive clinical trials or demonstration studies, careful modeling approaches can provide insight into who within a new HIV epidemic should be targeted for PrEP to prevent onward transmission as well as the strategies used to identify these individuals and link them to care. The investigators propose a modeling approach using an Agent Based Model (ABM) that moves beyond basic pathogen and transmission patterns to dealing with complex social interactions, including overlapping social and sexual networks as well as implementation realities, like finite PrEP resources, delayed linkage to PrEP care and early PreP care retention based upon empirically collected data in Athens Greece. Specifically the investigators aim to: 1) Characterize a bridging MSM network (n=308) by measuring individual-level risk factors, network-level connections, and HIV phylogenetic clusters; 2) Measure early PrEP cascade outcomes (HIV testing, PrEP linkage to care) of a sub-sample (n=50) of HIV uninfected MSM over the short term; and 3) Model the effects of this targeted public health PrEP intervention on HIV transmission in Athens. Agent-based models that account for empirical network structure are state-of-the-art in modeling HIV transmission and are flexible enough to address fundamental questions of who should receive PrEP and ultimately how a network-PrEP intervention can impact emerging/reemerging HIV epidemics.

研究类型

介入性

注册 (实际的)

308

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Athens、希腊、11527
        • Angelos Hatzakis

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 39年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • identify as male,
  • are between the ages of 18-39,
  • report sex with a man (oral or anal sex) in the past 12 months,
  • are willing/able to provide informed consent,
  • are willing to provide biological samples,
  • are Greek or English speakers and
  • are able to lucidly respond to interview questions

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:干涉

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PrEP prescription within 6 months of referral
大体时间:6 months
A first clinic visit where PrEP is prescribed within 6 months of referral. Clinic visit will be measured by abstracted clinical records and referral date will be collected by the field interviewer.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:John Schneider, MD, MPH、University of Chicago

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月1日

初级完成 (实际的)

2019年5月1日

研究完成 (实际的)

2019年5月1日

研究注册日期

首次提交

2016年1月26日

首先提交符合 QC 标准的

2016年2月3日

首次发布 (估计)

2016年2月8日

研究记录更新

最后更新发布 (实际的)

2020年1月9日

上次提交的符合 QC 标准的更新

2020年1月6日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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