Building on Needle Exchange to Optimize Prevention & Treatment

NCT ID: NCT03567174

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2022-08-02

Brief Summary

There are several biomedical interventions that can help people who inject drugs (particularly those with or at risk for HIV), but these services often do not get to the people most in need. In this project investigators propose to determine if delivery of these services to PWID by an integrated care van that is linked to a mobile syringe service program improves clinical outcomes, is feasible and sustainable, and is cost-effective.

Detailed Description

Biomedical interventions that have direct applicability to people who inject drugs (PWID) have flourished over the past 15 years (HIV treatment as prevention, pre-exposure prophylaxis, office-based medication-assisted treatment (MAT) with buprenorphine, and hepatitis C virus (HCV) treatment with direct acting agents). However, penetration of these interventions among PWID is low relative to the potential benefits. Syringe service programs (SSP) are an essential risk reduction service for PWID, and represent the outermost reach of public health services for this population. The Baltimore City Health Department (BCHD) and investigators at Johns Hopkins University are developing a dedicated integrated care van (ICV) to complement the city's mobile SSP, with the goals of optimizing the HIV care cascade in HIV-positive clients and extending needed biomedical interventions to PWID. A nurse practitioner, case worker, and peer navigators will engage HIV-positive clients (known and newly diagnosed) and collaborate closely with local HIV clinics to promote progress toward durable viral suppression. To support the ICV's role in HIV care facilitation, investigators propose an innovative application of the Center for Disease Control (CDC)-sponsored "Data to Care" initiative - a multi-source health service database designed to assist health departments track the HIV care cascade in real time. Additionally, the ICV will provide rapid HIV testing, PrEP screening and initiation, buprenorphine-based MAT, HCV testing and referrals to treatment, and wound care. Using a cluster-randomized trial design, investigators propose to determine whether the ICV intervention advances the HIV care cascade among HIV-positive PWID, improves the Pre-Exposure Prophylaxis (PrEP) continuum, and increases uptake of MAT and HCV treatment (Aim 1). Additionally, investigators will examine the implementation of the ICV intervention using a mixed methods approach among PWID, local/state public health stakeholders, and medical providers to examine the intervention's feasibility, acceptability, coverage, fidelity, and sustainability (Aim 2). Finally, investigators will determine the incremental cost-effectiveness of the ICV intervention (Aim 3). Investigators have assembled a multi-disciplinary team with methodological expertise in PWID interventions and cost-effectiveness evaluations, and longstanding collaboration with investigators' partners at the BCHD.

Conditions

Intravenous Drug Usage; HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Integrated care van (ICV)

ICV visits neighborhoods served by the mobile syringe service program weekly. ICV provides a range of services targeted to people who inject drugs - HIV testing, HCV testing, PrEP, MAT, wound care, case work services, on-site medical management and linkage.

Group Type: EXPERIMENTAL

Integrated care van (ICV)

Intervention Type: OTHER

Structural service delivery intervention

Control

No additional services provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated care van (ICV)

Structural service delivery intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• If HIV-positive: report history of injection drug use
• If HIV-negative: injected drugs ≥ 4 days in the last 30 days or shared a needle or syringe in the last 6 months

Exclusion Criteria

• Not competent to provide written informed consent
• Not willing or able to provide a blood specimen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Baltimore City Health Department

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory M Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Kathleen Page, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Baltimore City Syringe Service Program Neighborhood sites

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA045556

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00147873

Identifier Type: -

Identifier Source: org_study_id