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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 28 November 2022
Main ID:  NCT03447210
Date of registration: 21/02/2018
Prospective Registration: Yes
Primary sponsor: University of Washington
Public title: Study of HIV, HCV, APS and Phylogenetics for PWID SHARP
Scientific title: Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
Date of first enrolment: February 26, 2018
Target sample size: 4301
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03447210
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Kenya
Contacts
Name:     Joshua Herbeck, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Washington
Name:     Carey Farquhar, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  University of Washington
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
HIV/AIDS
Hepatitis C
Intervention(s)
Behavioral: Assisted Partner Services
Primary Outcome(s)
Injecting partners tested [Time Frame: 4 years]
Index participants linked to HIV and HCV care [Time Frame: 4 years]
Partners diagnosed with HIV and HCV [Time Frame: 4 years]
HCV-infected partners linked to HCV care [Time Frame: 4 years]
Sexual partners tested [Time Frame: 4 years]
HIV-infected partners linked to HIV care [Time Frame: 4 years]
Secondary Outcome(s)
Secondary ID(s)
STUDY00001536
R01DA043409
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Kenya Ministry of Health
Kenyatta National Hospital
National Institute on Drug Abuse (NIDA)
University of KwaZulu
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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