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临床试验/NCT03447210
NCT03447210已完成不适用

Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

University of Washington3 个研究点 分布在 1 个国家目标入组 4,301 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,301
试验地点
3
主要终点
HCV-infected partners linked to HCV care

研究概览

简要总结

This study will determine whether assisted partner notification services (APS) can identify and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C (HCV) co-infected persons who inject drugs (PWID). It will also define the risk factors for onward HIV and HCV transmission among PWID using viral phylogenetics.

详细描述

Overview: This NIH-funded study uses assisted partner services (APS) to identify HIV-infected and HCV-infected persons who inject drugs (PWID) in Kenya and link them to care. In addition to determining the role of APS in HIV and HCV case-finding for this hard-to-reach key population, we leverage our experience with HIV and HCV phylogenetics in the US and South Africa to define modes and risk factors for onward viral transmission. The specific aims of the proposal are as follows:

AIM 1. To determine whether contact tracing and partner notification practices, known in Kenya as assisted partner services (APS), can identify and link to care, the sexual and injection partners of HIV-infected and HIV/ hepatitis C (HCV) co-infected persons who inject drugs (PWID).

AIM 2. To define the risk factors for HIV transmission among PWID, and to elucidate the role of PWID in the overall Kenyan HIV epidemic, using viral genetic sequencing techniques.

AIM 3. To characterize the modes and risk factors for onward HCV transmission among PWID using viral genetic sequencing.

Design: We will enroll 1000 HIV-infected PWID through a needle and syringe exchange program (NSP) in Nairobi, Kenya. Each index participant will undergo a structured questionnaire, a rapid HCV test, a blood draw, and will provide locator information regarding their sexual and injection partners from the past 3 years. Study staff will then attempt to locate all partners. Once located, partner participants will undergo rapid HIV and HCV testing, a structured questionnaire, and a blood draw. All blood samples will be sent to a central laboratory in Nairobi for processing. Dried blood spot samples will be created in Nairobi and will later be sent to the University of KwaZulu-Natal for quantitative viral loads for both HIV and hepatitis C, and follow-up phylogenetic testing. All participants who test positive for HIV or hepatitis C will be referred for counseling and treatment. HIV care and treatment will take place at multiple local centers offering these services.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > or = 18 years of age
  • Active intravenous drug use (IDU) as defined by injecting at least twice in the past month
  • Willing and able to provide informed consent
  • HIV infected (either new diagnosis or known diagnosis)
  • Willing and able to provide locator information for sexual and/or injecting partners

排除标准

  • Classified as at high risk for IPV*
  • *Participants will be classified as at moderate risk for IPV if they report 1) history of IPV during their lifetime either from a current or past partner; and/or 2) fear of IPV if they participate in the study.

结局指标

主要结局

HCV-infected partners linked to HCV care

时间窗: 4 years

Percentage of HCV-infected partners linked to HCV care

Index participants linked to HIV and HCV care

时间窗: 4 years

Percentage of index participants linked to HIV and HCV care

Injecting partners tested

时间窗: 4 years

Numbers of injecting partners tested for HIV and HCV per index participant

Sexual partners tested

时间窗: 4 years

Numbers of sexual partners tested for HIV and HCV per index participant

Partners diagnosed with HIV and HCV

时间窗: 4 years

Number of partners newly diagnosed with HIV and HCV infection per index case

HIV-infected partners linked to HIV care

时间窗: 4 years

Percentage of HIV-infected partners linked to HIV care

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carey Farquhar

Professor

University of Washington

研究点 (3)

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