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BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

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ClinicalTrials.gov Identifier: NCT02796027
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabila El-Bassel, PhD, Columbia University

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Proportion of participants who are virally suppressed [ Time Frame: 12 months ]
Viral suppression via biological assay
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2016)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
Official Title  ICMJE BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Human Immunodeficiency Virus
  • Substance Abuse, Intravenous
Intervention  ICMJE Other: BRIDGE

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
Study Arms  ICMJE
  • Experimental: Experimental: BRIDGE
    Subjects assigned to this arm would receive an integrated HIV service model
    Intervention: Other: BRIDGE
  • 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.
Publications * McCrimmon T, Gilbert L, Hunt T, Terlikbayeva A, Wu E, Darisheva M, Primbetova S, Kuskulov A, Davis A, Dasgupta A, Schackman BR, Metsch LR, Feaster DJ, Baiserkin B, El-Bassel N. Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial. Implement Sci. 2019 Jun 14;14(1):62. doi: 10.1186/s13012-019-0909-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nabila El-Bassel, PhD 212-851-2391 ne5@columbia.edu
Listed Location Countries  ICMJE Kazakhstan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796027
Other Study ID Numbers  ICMJE AAAQ0952
1R01DA041063-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nabila El-Bassel, PhD, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Nabila El-Bassel, PhD Columbia University
PRS Account Columbia University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP