Study of HIV, HCV, APS and Phylogenetics for PWID (SHARP)
Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Nairobi、肯尼亚
- Githurai Drop-in Centre
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Nairobi、肯尼亚
- Ngara Health Centre
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Nairobi、肯尼亚
- Pangani Drop-in Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- > 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
Exclusion Criteria:
• 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 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 |
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实验性的:Assisted Partner Services
All participants in this arm will be offered assisted partner services (APS) which involves outreach to sexual partners and to individuals with whom they use injection drugs.
When partners are contacted they are offered HIV and HCV testing.
There is no comparison arm.
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Contact tracing for sexual and drug-sharing partners to notify about exposure to HIV and offer HIV and hepatitis C testing with linkage to care and partner services for those who test positive.
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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 |
---|---|---|
Sexual partners tested
大体时间:4 years
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Numbers of sexual partners tested for HIV and HCV per index participant
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4 years
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Injecting partners tested
大体时间:4 years
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Numbers of injecting partners tested for HIV and HCV per index participant
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4 years
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Partners diagnosed with HIV and HCV
大体时间:4 years
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Number of partners newly diagnosed with HIV and HCV infection per index case
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4 years
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HIV-infected partners linked to HIV care
大体时间:4 years
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Percentage of HIV-infected partners linked to HIV care
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4 years
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HCV-infected partners linked to HCV care
大体时间:4 years
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Percentage of HCV-infected partners linked to HCV care
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4 years
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Index participants linked to HIV and HCV care
大体时间:4 years
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Percentage of index participants linked to HIV and HCV care
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4 years
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合作者和调查者
合作者
调查人员
- 首席研究员:Carey Farquhar, MD, MPH、University of Washington
- 首席研究员:Joshua Herbeck, PhD、University of Washington
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00001536
- R01DA043409 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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丙型肝炎的临床试验
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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Haisco Pharmaceutical Group Co., Ltd.完全的
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
Assisted Partner Services的临床试验
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse招聘中