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Completed

NCT Number: NCT03447210

Study of HIV, HCV, APS and Phylogenetics for PWID

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assisted Partner Services

Behavioral

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.

Primary outcomes

  1. Sexual partners tested

    Time frame: 4 years

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

  2. Injecting partners tested

    Time frame: 4 years

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

  3. Partners diagnosed with HIV and HCV

    Time frame: 4 years

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

  4. HIV-infected partners linked to HIV care

    Time frame: 4 years

    Percentage of HIV-infected partners linked to HIV care

  5. HCV-infected partners linked to HCV care

    Time frame: 4 years

    Percentage of HCV-infected partners linked to HCV care

  6. Index participants linked to HIV and HCV care

    Time frame: 4 years

    Percentage of index participants linked to HIV and HCV care

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenya Ministry of Health
  • Kenyatta National Hospital
  • National Institute on Drug Abuse (NIDA)
  • University of KwaZulu

Registry information

Official study title

Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

Acronym: SHARP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2018
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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