Study of HIV, HCV, APS and Phylogenetics for PWID

Hepatitis C Clinical Trial

— SHARP  

Official title:

Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447210
• Other study ID #: STUDY00001536
• Secondary ID: R01DA043409
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4301
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Kenya	Githurai Drop-in Centre	Nairobi
Kenya	Ngara Health Centre	Nairobi
Kenya	Pangani Drop-in Centre	Nairobi

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Kenya Ministry of Health, Kenyatta National Hospital, National Institute on Drug Abuse (NIDA), University of KwaZulu

Country where clinical trial is conducted

Kenya, 

Outcome

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