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BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796027
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : May 31, 2022
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University

Brief Summary:
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 3 Kazakhstani city areas. 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 or disease Intervention/treatment Phase
Human Immunodeficiency Virus Substance Abuse, Intravenous Other: BRIDGE Not Applicable

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 increasing engagement in the HIV care continuum in 24 NSPs located in 3 geographically disparate Kazakhstani city areas 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 three regions 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped Wedge Design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Experimental: BRIDGE
NSPs assigned to this arm would receive an integrated HIV service model

BRIDGE, enhanced HIV service integration package, has three components:

  1. 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
  2. HCT using CTR with Rapid Testing
  3. 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
NSPs assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.

Primary Outcome Measures :
  1. Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome) [ Time Frame: 6 months ]
    NSP attendance from electronic case records

  2. Number of PWID who receive an HIV test (Effectiveness Outcome) [ Time Frame: 6 months ]
    HIV rapid testing

  3. Number of HIV positive PWID who are referred to HIV care from NSPs (Effectiveness Outcome) [ Time Frame: 6 months ]
    HIV care linkage from electronic case records

Secondary Outcome Measures :
  1. Number of HIV positive NSP clients who register at HIV care clinic (Effectiveness Outcome) [ Time Frame: 6-months ]
    Receipt of HIV care medical services confirmed by electronic health records

  2. Number of HIV positive NSP clients who have a viral load <1500 (Effectiveness Outcome) [ Time Frame: 6 months ]
    Viral load suppression confirmed by electronic health records

  3. Number of HIV positive NSP clients who initiate ART (Effectiveness Outcome) [ Time Frame: 6 months ]
    ART initiation confirmed by electronic health records

Other Outcome Measures:
  1. Incremental cost per participant who receives HIV-related medical services (Cost-Effectiveness Outcome) [ Time Frame: 6 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

  2. Implementation outcomes [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

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 scan

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): NCT02796027

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United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Global Health Research Center of Central Asia
Almaty, Kazakhstan
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Nabila El-Bassel, PhD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nabila El-Bassel, PhD, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02796027    
Other Study ID Numbers: AAAQ0952
1R01DA041063-01 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Acquired Immunodeficiency Syndrome
HIV Infections
Substance-Related Disorders
Substance Abuse, Intravenous
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Chemically-Induced Disorders
Mental Disorders