Study of HIV, HCV, APS and Phylogenetics for PWID (SHARP)

Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV/AIDS
• Intervention / Treatment: Behavioral: Assisted Partner Services

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Githurai Drop-in Centre
  • Nairobi, Kenya
    • Ngara Health Centre
  • Nairobi, Kenya
    • Pangani Drop-in Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA); Kenyatta National Hospital; University of KwaZulu; Kenya Ministry of Health
• Investigators: Principal Investigator: Carey Farquhar, MD, MPH, University of Washington; Principal Investigator: Joshua Herbeck, PhD, University of Washington

Publications and helpful links

General Publications

• Monroe-Wise A, Mbogo L, Guthrie B, Bukusi D, Sambai B, Chohan B, Scott J, Cherutich P, Musyoki H, Bosire R, Dunbar M, Macharia P, Masyuko S, Wilkinson E, De Oliveira T, Ludwig-Barron N, Sinkele B, Herbeck J, Farquhar C. Peer-mediated HIV assisted partner services to identify and link to care HIV-positive and HCV-positive people who inject drugs: a cohort study protocol. BMJ Open. 2021 Apr 24;11(4):e041083. doi: 10.1136/bmjopen-2020-041083.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: HIV testing; HIV care cascade; Assisted partner services; Persons who inject drugs (PWID); Phylogenetics; HCV testing
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: STUDY00001536; R01DA043409 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 5-10 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No