BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
Primary Purpose
Human Immunodeficiency Virus, Substance Abuse, Intravenous
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BRIDGE
Sponsored by
About this trial
This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring Health Services Research
Eligibility 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 scan
Sites / Locations
- Columbia University School of Social Work
- Global Health Research Center of Central Asia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: BRIDGE
Pre-implementation
Arm Description
NSPs assigned to this arm would receive an integrated HIV service model
NSPs assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.
Outcomes
Primary Outcome Measures
Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome)
NSP attendance from electronic case records
Number of PWID who receive an HIV test (Effectiveness Outcome)
HIV rapid testing
Number of HIV positive PWID who are referred to HIV care from NSPs (Effectiveness Outcome)
HIV care linkage from electronic case records
Secondary Outcome Measures
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
Number of HIV positive NSP clients who have a viral load <1500 (Effectiveness Outcome)
Viral load suppression confirmed by electronic health records
Number of HIV positive NSP clients who initiate ART (Effectiveness Outcome)
ART initiation confirmed by electronic health records
Full Information
NCT ID
NCT02796027
First Posted
June 7, 2016
Last Updated
May 26, 2022
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02796027
Brief Title
BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
Official Title
BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Substance Abuse, Intravenous
Keywords
Health Services Research
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped Wedge Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
616 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: BRIDGE
Arm Type
Experimental
Arm Description
NSPs assigned to this arm would receive an integrated HIV service model
Arm Title
Pre-implementation
Arm Type
No Intervention
Arm Description
NSPs assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.
Intervention Type
Other
Intervention Name(s)
BRIDGE
Other Intervention Name(s)
Enhanced HIV service integration package
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome)
Description
NSP attendance from electronic case records
Time Frame
6 months
Title
Number of PWID who receive an HIV test (Effectiveness Outcome)
Description
HIV rapid testing
Time Frame
6 months
Title
Number of HIV positive PWID who are referred to HIV care from NSPs (Effectiveness Outcome)
Description
HIV care linkage from electronic case records
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of HIV positive NSP clients who register at HIV care clinic (Effectiveness Outcome)
Description
Receipt of HIV care medical services confirmed by electronic health records
Time Frame
6-months
Title
Number of HIV positive NSP clients who have a viral load <1500 (Effectiveness Outcome)
Description
Viral load suppression confirmed by electronic health records
Time Frame
6 months
Title
Number of HIV positive NSP clients who initiate ART (Effectiveness Outcome)
Description
ART initiation confirmed by electronic health records
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incremental cost per participant who receives HIV-related medical services (Cost-Effectiveness Outcome)
Description
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
Time Frame
6 months
Title
Implementation outcomes
Description
Fidelity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 scan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabila El-Bassel, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Global Health Research Center of Central Asia
City
Almaty
Country
Kazakhstan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31200757
Citation
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.
Results Reference
derived
Learn more about this trial
BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs
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