Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02796027 |
| Other study ID # |
AAAQ0952 |
| Secondary ID |
1R01DA041063-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
