ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03447210
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Kenyatta National Hospital
Kenya Ministry of Health
University of KwaZulu
Information provided by (Responsible Party):
Carey Farquhar, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Hepatitis C Behavioral: Assisted Partner Services Not Applicable

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  (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)
Primary Purpose: Diagnostic
Official Title: Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
Contact: Aliza Monroe-Wise, MD, MSc +1-410-299-1445 alizamw@uw.edu
Contact: Loice Mbogo loice.mbogo@gmail.com

Locations
Kenya
Githurai Drop-in Centre Recruiting
Nairobi, Kenya
Contact: Esther Gitau       esther.gitau44@gmail.com   
Contact: William Sinkele       sinkele@gmail.com   
Ngara Health Centre Recruiting
Nairobi, Kenya
Contact: Robert Midambo       rmidambo84@gmail.com   
Pangani Drop-in Centre Recruiting
Nairobi, Kenya
Contact: Esther Gitau       esther.gitau44@gmail.com   
Contact: William Sinkele       sinkele@gmail.com   
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Kenyatta National Hospital
Kenya Ministry of Health
University of KwaZulu
Investigators
Principal Investigator: Joshua Herbeck, PhD University of Washington
Principal Investigator: Carey Farquhar, MD, MPH University of Washington

Responsible Party: Carey Farquhar, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03447210     History of Changes
Other Study ID Numbers: STUDY00001536
R01DA043409 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 5-10 years

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carey Farquhar, University of Washington:
Persons who inject drugs (PWID)
Phylogenetics
HIV testing
HCV testing
HIV care cascade
Assisted partner services

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases