AzTrials
AzTrials

Human Immunodeficiency VirusNCT02796027

BRIDGE: Improving HIV Service Delivery for People Who Inject Drugs

A study testing BRIDGE in people with Human Immunodeficiency Virus and Substance Abuse, Intravenous, run by Columbia University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BRIDGE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
616 participants
Where
2 sitesin 2 countries
Study dates
1 Feb 2017to 1 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Columbia University School of Social Work

    New York, New York, 10027

Other trials in United States

Kazakhstan1 site

  • Global Health Research Center of Central Asia

    Almaty

Other trials in Kazakhstan

About this study

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.

Read the 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.

Being tested
BRIDGE
Keywords
Health Services Research
Medical subject headings
Acquired Immunodeficiency Syndrome, Substance Abuse, Intravenous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRIDGEOther

    Also called Enhanced HIV service integration package

    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
Study groups in NCT02796027
Study groupRoleWhat they receive
Experimental: BRIDGEExperimentalNSPs assigned to this arm would receive an integrated HIV service model
Receives: Other: BRIDGE
Pre-implementationNo interventionNSPs assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome)

    NSP attendance from electronic case records

    Measured: 6 months

  2. Number of PWID who receive an HIV test (Effectiveness Outcome)

    HIV rapid testing

    Measured: 6 months

  3. Number of HIV positive PWID who are referred to HIV care from NSPs (Effectiveness Outcome)

    HIV care linkage from electronic case records

    Measured: 6 months

Secondary outcomes (3)

  1. 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

    Measured: 6-months

  2. Number of HIV positive NSP clients who have a viral load <1500 (Effectiveness Outcome)

    Viral load suppression confirmed by electronic health records

    Measured: 6 months

  3. Number of HIV positive NSP clients who initiate ART (Effectiveness Outcome)

    ART initiation confirmed by electronic health records

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study start1 Feb 2017
  3. Primary completion1 Aug 2020
  4. Study completion1 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped Wedge Design
Masking
None (open label)
Enrolment
616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02796027
Sponsor's protocol ID
AAAQ0952
Other IDs
1R01DA041063-01
Status last verified
Jul 2021
First submitted
7 Jun 2016
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36454567

  • 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.

    PubMed 31200757

Questions about this trial

What is this clinical trial studying?

A study testing BRIDGE in people with Human Immunodeficiency Virus and Substance Abuse, Intravenous, run by Columbia University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of PWID who attend Needle Syringe Programs (NSPs) (Effectiveness Outcome) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02796027, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in