Trials Sponsors Conditions Drugs Pricing

Conditions

HIV/AIDS Intravenous Drug Usage

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
+11 more secondary outcomes

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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Baltimore City Health Department
Othercollaborator
National Institute on Drug Abuse (NIDA)
NIHcollaborator
Johns Hopkins University

Study Sites (1)

Baltimore City Syringe Service Program Neighborhood sites

Baltimore, Maryland, 21205, United States

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis C

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital Diseases

Results Point of Contact

Title: Gregory M. Lucas
Organization: Johns Hopkins University

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

Enrollment

720 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 25, 2018

Study Start

June 22, 2018

Actual (reported)

Building on Needle Exchange to Optimize Prevention & Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Other Outcomes (2)

Study Arms (2)

Integrated care van (ICV)

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Other Outcomes (2)

Study Arms (2)

Integrated care van (ICV)

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations