Building on Needle Exchange to Optimize Prevention & Treatment

NCT03567174 | Completed Results

• 2 other identifiers: IRB00147873R01DA045556
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Drug Usage; HIV/AIDS

Keywords

hepatitis C

Outcome Measures

Primary Outcomes (1)

• Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)

  To capture the multifaceted nature of the ICV intervention and the array of health issues relevant to PWID, we developed a scoring rubric based on World Health Organization (WHO) guidelines for evidence-based PWID services, a predictive risk model for HIV seroconversion among PWID developed by the Baltimore-based ALIVE study, the HCV care continuum, and the overdose epidemic. In the scoring rubric, points are allocated on the basis of failure to access evidence-based services, riskier behaviors, and adverse outcomes. This outcome will be assessed in all participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 15, with higher scores indicating worse overall status.

  Between baseline visit and the V7 follow-up visit at 7 months

Secondary Outcomes (16)

• HIV Care Continuum

  Between 6 months prior to and the V7 follow-up visit at 7 months

• HIV Testing

  Between 6 months prior to and the V7 follow-up visit at 7 months

• Pre-exposure Prophylaxis (PrEP) Continuum

  Between 6 months prior to and the V7 follow-up visit at 7 months

• HCV Care Continuum

  Between 6 months prior to and the V7 follow-up visit at 7 months

• HCV Testing

  Between 6 months prior to and the V7 follow-up visit at 7 months

Other Outcomes (2)

• Participants Who Completed Qualitative Assessments

  12 months

• Costs and Cost Effectiveness

  12 months

Study Arms (2)

Integrated care van (ICV)

EXPERIMENTAL

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.

Other: Integrated care van (ICV)

Control

NO INTERVENTION

No additional services provided.

Interventions

Integrated care van (ICV) OTHER

Structural service delivery intervention

Integrated care van (ICV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Baltimore City Health Department: collaborator

Study Sites (1)

Baltimore City Syringe Service Program Neighborhood sites

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gregory M. Lucas
• Organization: Johns Hopkins University

glucas@jhmi.edu

410 614 0560

Study Officials

• Gregory M Lucas, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Kathleen Page, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized trial

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: June 22, 2018
• Primary Completion: March 12, 2020
• Study Completion: August 2, 2022
• Last Updated: February 9, 2026
• Results First Posted: December 27, 2022

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)