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Clinical Trials

MainTitle

BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2017 by Nabila El-Bassel, PhD, Columbia University

Sponsor
Columbia University

Collaborator
National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party)
Nabila El-Bassel, PhD, Columbia University

ClinicalTrials.gov Identifier
NCT02796027

First received: June 7, 2016
Last updated: July 18, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

Scaling up integrated, cost-efficient HIV services for people who inject drugs (PWID) in Needle Syringe Programs (NSPs) is urgently needed in Kazakhstan, where only one-third of the estimated 19,000 HIV-positive PWID are ever linked to HIV care and only 10% initiate ART with 4% achieving viral suppression. The study's aim is to evaluate the implementation, effectiveness, and sustainability of an integrated HIV service model in 24 NSPs located in 4 Kazakhstani cities. This model will employ highly effective strategies that will include peer-driven recruitment of PWID in NSPs using social network strategies (SNS), integrating rapid HIV testing in NSPs with HIV Care Clinic nurses, and linking HIV positive PWID in NSPs to HIV care using the ARTAS (Anti-Retroviral Treatment and Access to Services) case management model. Findings will have important public health implications for improving HIV service delivery for PWID in the Central Asian region and other countries with injection driven epidemics.

Condition Intervention
Human Immunodeficiency Virus
Substance Abuse, Intravenous

Other : BRIDGE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

Further study details as provided by Nabila El-Bassel, PhD, Columbia University:

Primary Outcome Measures

  • Proportion of participants who are virally suppressed [ Time Frame: 12 months ]
    Viral suppression via biological assay
Secondary Outcome Measures:
  • Proportion of participants who are receiving HIV-related medical services [ Time Frame: 12-months ]
    Self-reported receipt of medical services confirmed by clinic records/report
Other Outcome Measures:
  • Incremental cost per participant who receives HIV-related medical services [ Time Frame: Up to 42 months ]
    Costs measured from staff time records, clinical and participant records, and overhead from standard program records/reports, multiplied by published labor rates and service charges

Estimated Enrollment: 600
Study Start Date: February 1, 2017
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Experimental: BRIDGE
Subjects assigned to this arm would receive an integrated HIV service model
Other: BRIDGE
    BRIDGE, enhanced HIV service integration package, has three components:
    • peer driven recruitment using a Social Network Strategy (SNS) -- which has been designated as a "high impact and highly effective" strategy by the CDC for reaching out and engaging PWID in HIV testing
    • HCT using CTR with Rapid Testing
    • ARTAS -- a CDC case management strategy for linking HIV-positive PWID to HIV care that addresses specific barriers and gaps in HIV service delivery in NSPs

    Other Name: Enhanced HIV service integration package
    No Intervention: Pre-implementation
    Subjects assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.

    Detailed Description:

    The study is designed to evaluate the implementation and effectiveness of an enhanced HIV service integration package (BRIDGE) that may be scaled up in Kazakhstan's vast network of needle-syringe programs (NSPs) for PWID. This package includes low threshold strategies of peer-driven recruitment, HIV counseling and rapid testing (HCT) in NSPs conducted by HIV care clinic nurses, and ARTAS, Centers for Disease Control and Prevention's highly effective case management strategies for linking PWID to HIV care. BRIDGE is systematically designed to address specific service barriers to testing PWID for HIV, linking them to HIV care, and promoting ART (antiretroviral therapy) initiation. This study will employ an innovative stepped wedge design to evaluate implementation and effectiveness of BRIDGE on improving linkage to HIV care and initiation of ART in 24 NSPs located in 4 geographically disparate Kazakhstani cities using site-level data collected from NSPs and HIV clinics. Investigators will conduct a longitudinal panel study with a random sample of HIV-positive PWID (N=600) from four cities in Kazakhstan using repeated assessments at baseline, 6-, and 12-months follow-up. This study will employ mixed methods to identify multi-level structural, community, and organizational factors that influence the implementation and effectiveness of BRIDGE and the cost of BRIDGE, examining implications for cost-effectiveness, feasibility of expansion, and sustainability. The study builds on the investigative team's extensive HIV intervention research among PWID in Kazakhstan in collaboration with the Republican AIDS Center over the past decade. It addresses implementation research questions to improve and integrate HIV service delivery systems for PWID that are not only important to the region, but have relevance to other countries that have concurrent injection drug use and HIV epidemics.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • positive confirmatory HIV test;
    • aged 18 or older;
    • report injecting any drug in the past 30 days; and
    • have had one or more contacts with NSP staff at one of the 24 NSPs


    Exclusion Criteria:
    • show evidence of significant psychiatric or cognitive impairment that would limit effective participation as confirmed during informed consent;
    • are not fluent in Russian or Kazakh as determined during informed consent; or
    • have been previously screened for or enrolled in the study confirmed by fingerprint
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    contacts and locations

    Contacts and Locations

    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, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02796027

    Contacts

    Contact:   Nabila El-Bassel, PhD 212-851-2391 ne5@columbia.edu

    Locations

    United States, New York
    Columbia University School of Social Work Active, not recruiting
    New York, New York, United States, 10027
    Kazakhstan
    Global Health Research Center of Central Asia Recruiting
    Almaty, Kazakhstan
    Contact: Assel Terlikbayeva, MD

    Sponsors and Collaborators

    Columbia University
    National Institute on Drug Abuse (NIDA)

    Investigators

    Principal Investigator: Nabila El-Bassel, PhD Columbia University
    More Information

    More Information


    Responsible Party: Nabila El-Bassel, PhD, Professor, Columbia University  
    ClinicalTrials.gov Identifier: NCT02796027   History of Changes  
    Other Study ID Numbers: AAAQ0952  
      1R01DA041063-01  
    Study First Received: June 7, 2016  
    Last Updated: July 18, 2017  

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

    Keywords provided by Nabila El-Bassel, PhD, Columbia University:

    Health Services Research

    Additional relevant MeSH terms:
    Immunologic Deficiency Syndromes
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Substance-Related Disorders
    Substance Abuse, Intravenous

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.