Study of HIV, HCV, APS and Phylogenetics for PWID

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

Conditions
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HIV/AIDS, Hepatitis C

Intervention / Treatment
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* Behavioral: Assisted Partner Services


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study with nested cross-sectional studies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted Partner Services<br>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. | Behavioral: Assisted Partner Services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual partners tested | Numbers of sexual partners tested for HIV and HCV per index participant | 4 years | 
| Injecting partners tested | Numbers of injecting partners tested for HIV and HCV per index participant | 4 years | 
| Partners diagnosed with HIV and HCV | Number of partners newly diagnosed with HIV and HCV infection per index case | 4 years | 
| HIV-infected partners linked to HIV care | Percentage of HIV-infected partners linked to HIV care | 4 years | 
| HCV-infected partners linked to HCV care | Percentage of HCV-infected partners linked to HCV care | 4 years | 
| Index participants linked to HIV and HCV care | Percentage of index participants linked to HIV and HCV care | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persons who inject drugs (PWID), Phylogenetics, HIV testing, HCV testing, HIV care cascade, Assisted partner services