NCT02796027

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
616

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 31, 2022

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

June 7, 2016

Last Update Submit

May 26, 2022

Conditions

Keywords

Health Services Research

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Number of HIV positive NSP clients who register at HIV care clinic (Effectiveness Outcome)

    6-months

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

    6 months

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

    6 months

Other Outcomes (2)

  • Incremental cost per participant who receives HIV-related medical services (Cost-Effectiveness Outcome)

    6 months

  • Implementation outcomes

    6 months

Study Arms (2)

Experimental: BRIDGE

EXPERIMENTAL

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

Other: BRIDGE

Pre-implementation

NO INTERVENTION

NSPs assigned to this arm would receive standard care (treatment as usual) and would not be exposed to the integrated HIV service model.

Interventions

BRIDGEOTHER

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

Also known as: Enhanced HIV service integration package
Experimental: BRIDGE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

Global Health Research Center of Central Asia

Almaty, Kazakhstan

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSubstance Abuse, Intravenous

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Nabila El-Bassel, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped Wedge Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

February 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

May 31, 2022

Record last verified: 2021-07

Locations