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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse, Intravenous; Human Immunodeficiency Virus
• Intervention / Treatment: Other: BRIDGE

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.

• Study Type: Interventional
• Enrollment (Actual): 616
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • Global Health Research Center of Central Asia
• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: BRIDGE; NSPs 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome)	NSP attendance from electronic case records	6 months
Number of PWID who receive an HIV test (Effectiveness Outcome)	HIV rapid testing	6 months
Number of HIV positive PWID who are referred to HIV care from NSPs (Effectiveness Outcome)	HIV care linkage from electronic case records	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HIV positive NSP clients who register at HIV care clinic (Effectiveness Outcome)	Receipt of HIV care medical services confirmed by electronic health records	6-months
Number of HIV positive NSP clients who have a viral load <1500 (Effectiveness Outcome)	Viral load suppression confirmed by electronic health records	6 months
Number of HIV positive NSP clients who initiate ART (Effectiveness Outcome)	ART initiation confirmed by electronic health records	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost per participant who receives HIV-related medical services (Cost-Effectiveness Outcome)	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	6 months
Implementation outcomes	Fidelity	6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Nabila El-Bassel, PhD, Columbia University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Health Services Research
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Substance-Related Disorders; Substance Abuse, Intravenous; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: AAAQ0952; 1R01DA041063-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No