Study of HIV, HCV, APS and Phylogenetics for PWID
SHARP
Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
2 other identifiers
interventional
4,301
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2018
CompletedStudy Start
First participant enrolled
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedNovember 21, 2022
November 1, 2022
4 years
February 21, 2018
November 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
Assisted Partner Services
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institute on Drug Abuse (NIDA)collaborator
- Kenyatta National Hospitalcollaborator
- Kenya Ministry of Healthcollaborator
- University of KwaZulucollaborator
Study Sites (3)
Githurai Drop-in Centre
Nairobi, Kenya
Ngara Health Centre
Nairobi, Kenya
Pangani Drop-in Centre
Nairobi, Kenya
Related Publications (1)
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.
PMID: 33895711DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Herbeck, PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Carey Farquhar, MD, MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2018
First Posted
February 27, 2018
Study Start
February 26, 2018
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
November 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 5-10 years
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.