Clinical trial NCT03567174: Building on Needle Exchange to Optimize Prevention & Treatment
Official title: Building on Needle Exchange to Optimize Prevention & Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Drug Usage
HIV/AIDS
Keywords: hepatitis C
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Baltimore City Health Department
First posted: 2018-06-25
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)
timeFrame: Between baseline visit and the V7 follow-up visit at 7 months
Secondary outcomes:
measure: HIV Care Continuum
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: HIV Testing
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Pre-exposure Prophylaxis (PrEP) Continuum
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: HCV Care Continuum
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: HCV Testing
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Medication for Opioid Use Disorder (MOUD) Use
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Syringe Service Program (SSP) Use
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Naloxone Overdose Kit
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Injection Drug Use
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Recent Drug Use
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Sharing Injection Equipment
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Non-fatal Overdose
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: Emergency Department (ED) Use
timeFrame: Between 6 months prior to and the V7 follow-up visit at 7 months
measure: HIV Seroconversion
timeFrame: Between baseline visit and the V7 follow-up visit at 7 months
measure: HIV Seroconversion
timeFrame: 12 months
measure: HCV Seroconversion
timeFrame: Between baseline visit and the V7 follow-up visit at 7 months
measure: HCV Seroconversion
timeFrame: 12 months
measure: Mortality Rate
timeFrame: Between baseline visit and the V7 follow-up visit at 7 months
Other outcomes:
measure: Qualitative Assessments
timeFrame: 12 months
measure: Costs and Cost Effectiveness
timeFrame: 12 months
Locations:
city: Baltimore
country: United States
facility: Baltimore City Syringe Service Program Neighborhood sites
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory M Lucas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Kathleen Page, MD
role: PRINCIPAL_INVESTIGATOR
References: