An interventional study of Assisted Partner Services in HIV/AIDS and Hepatitis C, sponsored by University of Washington. Completed at 3 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
*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.
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
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.
Sexual partners tested
Numbers of sexual partners tested for HIV and HCV per index participant
Time frame: 4 years
Injecting partners tested
Numbers of injecting partners tested for HIV and HCV per index participant
Time frame: 4 years
Partners diagnosed with HIV and HCV
Number of partners newly diagnosed with HIV and HCV infection per index case
Time frame: 4 years
HIV-infected partners linked to HIV care
Percentage of HIV-infected partners linked to HIV care
Time frame: 4 years
HCV-infected partners linked to HCV care
Percentage of HCV-infected partners linked to HCV care
Time frame: 4 years
Index participants linked to HIV and HCV care
Percentage of index participants linked to HIV and HCV care
Time frame: 4 years
Plan to share: Yes — The proposed studies will include the following data: self-reported demographic and behavioral data, medical/sexual histories, HIV/HCV test results, and HIV/HCV genetic sequences. To facilitate the data sharing process, we will consider the need for data sharing in the study design, creation of informed consent documents, and the structure of data collection. Release of completed viral gene sequences (on NCBI Genbank) shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Washington