Study of HIV, HCV, APS and Phylogenetics (SHARP) Prevention (SHARP)
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|ClinicalTrials.gov Identifier: NCT03447210|
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment|
|HIV/AIDS Hepatitis C||Behavioral: Assisted Partner Services|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective cohort study with nested cross-sectional studies|
|Masking:||None (Open Label)|
|Official Title:||Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention|
|Anticipated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: 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.
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 [ Time Frame: 4 years ]Numbers of sexual partners tested for HIV and HCV per index participant
- Needle-sharing partners tested [ Time Frame: 4 years ]Numbers of needle-sharing partners tested for HIV and HCV per index participant
- Partners diagnosed with HIV and HCV [ Time Frame: 4 years ]Number of partners newly diagnosed with HIV and HCV infection per index case
- HIV-infected partners linked to HIV care [ Time Frame: 4 years ]Percentage of HIV-infected partners linked to HIV care
- HCV-infected partners linked to HCV care [ Time Frame: 4 years ]Percentage of HCV-infected partners linked to HCV care
- Index participants linked to HIV and HCV care [ Time Frame: 4 years ]Percentage of index participants linked to HIV and HCV care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447210
|Contact: Aliza Monroe-Wise, MD, MPHfirstname.lastname@example.org|
|Contact: Loice Mbogoemail@example.com|
|Githurai Drop-in Centre||Not yet recruiting|
|Contact: Esther Gitau firstname.lastname@example.org|
|Contact: William Sinkele email@example.com|
|Pangani Drop-in Centre||Not yet recruiting|
|Contact: Esther Gitau firstname.lastname@example.org|
|Contact: William email@example.com|
|Principal Investigator:||Joshua Herbeck, PhD||University of Washington|
|Principal Investigator:||Carey Farquhar||University of Washington|