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Completed

NCT Number: NCT02796027

BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bridge

Other

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 names: Enhanced HIV service integration package

Primary outcomes

  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 outcomes

  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 outcomes

  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

    Fidelity

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2016
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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