BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

NCT ID: NCT02796027

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

616 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Substance Abuse, Intravenous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped Wedge Design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: BRIDGE

NSPs assigned to this arm would receive an integrated HIV service model

Group Type EXPERIMENTAL

BRIDGE

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enhanced HIV service integration package

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nabila El-Bassel, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nabila El-Bassel, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University School of Social Work

New York, New York, United States

Site Status

Global Health Research Center of Central Asia

Almaty, , Kazakhstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Kazakhstan

References

Explore related publications, articles, or registry entries linked to this study.

El-Bassel N, McCrimmon T, Wu E, Chang M, Terlikbayeva A, Hunt T, Darisheva M, Primbetova S, Davis A, Metsch LR, Feaster DJ, Baiserkin B, Abishev A, Denebayeva A, Sagimbayev B, Kurmetova K, Mashirov K, Gilbert L. Effectiveness of an Intervention to Improve HIV Service Delivery for People Who Inject Drugs in Kazakhstan: A Cluster Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244734. doi: 10.1001/jamanetworkopen.2022.44734.

Reference Type DERIVED
PMID: 36454567 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31200757 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01DA041063-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAQ0952

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HST for Female Sex Workers/Drug Users in Kazakhstan
NCT06150937 ACTIVE_NOT_RECRUITING NA
Integrated HIV Prevention and HCV Care for PWID
NCT03981445 ACTIVE_NOT_RECRUITING NA