NCT03567174

Building on Needle Exchange to Optimize Prevention & Treatment

Completed NA Results posted Last updated 9 February 2026

What this trial tests

NA trial testing Integrated care van (ICV) in Intravenous Drug Usage in 720 participants. Completed in 2 August 2022.

Timeline

22 June 2018

Primary endpoint
12 March 2020

2 August 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	720
Start date	22 June 2018
Primary completion	12 March 2020
Estimated completion	2 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Integrated care van (ICV)

Conditions studied

• Intravenous Drug Usage — all drugs for Intravenous Drug Usage →
• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Intravenous Drug Usage or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes) Primary · Between baseline visit and the V7 follow-up visit at 7 months

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 sc

Group	Value	95% CI
Integrated Care Van (ICV)	5.34	± 2.35
Control	5.64	± 2.56

HIV Care Continuum Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in HIV-positive participants at all time points. The score is based on self-report and biomarker testing, and ranges from 0 to 2 with higher scores indicating poorer HIV care engagement. Participants with viral load suppression (HIV RNA \<20 c/mL) are counted and assigned a score=0; those with non-suppressed viral load but who took antiretroviral drugs in the prior 30 days or who had a visit with an HIV care provider in the prior 6 months are counted and assigned a score=1; those with non-suppressed viral load, and who did not take antiretroviral drugs (ARVs) in

Suppressed (HIV RNA undetectable)

Group	Value	95% CI
Integrated Care Van (ICV)	13
Control	19

Not suppressed, ARVs in prior 30 days or provider visit last 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	18
Control	10

Not suppressed, no ARVs and no provider visit last 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	1
Control	4

HIV Testing Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in HIV-negative participants at all time points. The score is based on self-report and biomarker testing, and ranges from 0 to 1 with higher scores indicating poorer HIV care engagement. Participants who had an HIV test in the prior 6 months will be counted and assigned a score=0; those who did not have an HIV test in the prior 6 months will be counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Had an HIV test in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	234
Control	202

Did not have an HIV test in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	2
Control	8

Pre-exposure Prophylaxis (PrEP) Continuum Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in HIV-negative participants at all time points. The score is based on self-report, and ranges from 0 to 1 with higher scores indicating poorer engagement with PrEP. Participants who used PrEP in the prior 6 months are counted and assigned a score=0; those who did not use PrEP in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Used PrEP in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	0
Control	4

Did not use PrEP in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	236
Control	206

HCV Care Continuum Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in HCV-positive participants at all time points. The score is based on self-report and biomarker testing, and ranges from 0 to 2 with higher scores indicating poorer engagement with HCV care. Participants successfully treated for HCV with undetectable HCV RNA are counted and assigned a score=0; those who have detectable HCV RNA but who have been evaluated or treated for HCV in the prior 6 months are counted and assigned a score=1; those who have detectable HCV RNA, have not been treated or evaluated in the prior 6 months are counted and assigned a score=2. The co

Successfully treated for HCV with undetectable HCV RNA

Group	Value	95% CI
Integrated Care Van (ICV)	34
Control	20

Detectable HCV RNA but who have been evaluated or treated for HCV in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	36
Control	25

Detectable HCV RNA, have not been treated or evaluated in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	75
Control	58

HCV Testing Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in HCV-negative participants and HCV-antibody positive participants who spontaneously cleared the infection without completing treatment at all time points. The score is based on self-report and biomarker testing, and ranges from 0 to 1 with higher scores indicating poorer HIV care engagement. Participants who had an HCV test in the prior 6 months are counted and assigned a score=0; those who did not have an HCV test in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated sc

Had an HCV test in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	65
Control	66

Did not have an HCV test in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	57
Control	73

Medication for Opioid Use Disorder (MOUD) Use Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 1. Participants who used MOUD in the prior 6 months are counted and assigned a score=0; those who have not used MOUD in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Used MOUD in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	165
Control	134

Have not used MOUD in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	103
Control	109

Syringe Service Program (SSP) Use Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in participants who report injection drug use in the prior 6 months, at all time points. The score is based on self-report, and ranges from 0 to 1 with higher scores indicating poorer engagement in risk reduction services. Participants who used an SSP in the prior 6 months are counted and assigned a score=0; those who did not use an SSP in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Used an SSP in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	223
Control	208

Did not use an SSP in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	45
Control	35

Naloxone Overdose Kit Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 1 with higher scores indicating poorer engagement in risk reduction services. Participants who possess a naloxone overdose kit that is usually accessible when they use drugs (i.e, where they usually use drugs) are counted and assigned a score=0; those who do not possess a naloxone overdose kit that is in an accessible location are counted and assigned score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored

Possess a naloxone overdose kit that is in an accessible location (where they usually use drugs)

Group	Value	95% CI
Integrated Care Van (ICV)	164
Control	157

Do not possess a naloxone overdose kit that is usually accessible when they use drugs

Group	Value	95% CI
Integrated Care Van (ICV)	104
Control	86

Injection Drug Use Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in all participants at all time points. The score is based on self-report and ranges from 0 to 1 with higher scores indicating riskier behavior. Participants who did not inject drugs in the prior 6 months are counted and assigned a score=0; those who did inject drugs in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Did not inject drugs in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	108
Control	85

Did inject drugs in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	160
Control	158

Recent Drug Use Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in all participants at all time points. The score is based on biomarker testing and ranges from 0 to 1 with higher scores indicating riskier behavior. Participants who have a negative urine drug test for selected drugs are counted and assigned a score=0; those who have a positive urine drug test for selected drugs are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome. Selected drugs include the primary drug or metabolites of fentanyl, h

Have a negative urine drug test for selected drugs

Group	Value	95% CI
Integrated Care Van (ICV)	42
Control	25

Have a positive urine drug test for selected drugs

Group	Value	95% CI
Integrated Care Van (ICV)	225
Control	217

Sharing Injection Equipment Secondary · Between 6 months prior to and the V7 follow-up visit at 7 months

This outcome will be assessed in all participants at all time points. The score is based on self-report and ranges from 0 to 2 with higher scores indicating riskier behavior. Participants who did not share needle/syringe or cotton/cooker in the prior 6 months are counted and assigned a score=0; those who shared cotton/cooker but did not share needle/syringes in the prior 6 months are counted and assigned a score=1; those who shared needle/syringes in the prior 6 months are counted and assigned a score=2. The counts of participants will be reported for this outcome measure and the associated s

Did not share needle/syringe or cotton/cooker in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	202
Control	175

Shared cotton/cooker but did not share needle/syringes in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	21
Control	23

Shared needle/syringes in the prior 6 months

Group	Value	95% CI
Integrated Care Van (ICV)	45
Control	45

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was followed for adverse event data during study visits. Death data was collected for all participants through the end of the Pre-COVID V14 Follow-up window for participants followed from the first 4 sites and through the end of the Post-COVID V14 Follow-up window for participants in the last 8 sites (maximum of 4 years).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Integrated Care Van (ICV)

Serious: 24/360 (7%)

Deaths: 24/360

Control

Serious: 31/360 (9%)

Deaths: 31/360

Serious adverse events (1 terms)

Reaction	System	Integrated Care Van (ICV)	Control
Death	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03567174 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile low-threshold buprenorphine integrated with infectious disease services.
   Rosecrans A, Harris R, Saxton RE, Cotterell M, et al · · 2022 · cited 31× · PMID 34238629 · DOI 10.1016/j.jsat.2021.108553
2. Integrated care van delivery of evidence-based services for people who inject drugs: A cluster-randomized trial.
   Page KR, Weir BW, Zook K, Rosecrans A, et al · · 2024 · cited 7× · PMID 38561602 · DOI 10.1111/add.16486
3. An Analysis of Social Determinants of Health and Their Implications for Hepatitis C Virus Treatment in People Who Inject Drugs: The Case of Baltimore.
   Gonzalez Corro LA, Zook K, Landry M, Rosecrans A, et al · · 2024 · cited 6× · PMID 38567197 · DOI 10.1093/ofid/ofae107
4. Hazardous Alcohol Use and Its Effect on Direct-Acting Antiviral Therapy Initiation among People with Active Injection Drug Use and Current Hepatitis C Infection.
   Karimi-Sari H, Lucas GM, Zook K, Weir B, et al · · 2024 · PMID 39339891 · DOI 10.3390/v16091416