- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567174
Building on Needle Exchange to Optimize Prevention & Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Baltimore City Syringe Service Program Neighborhood sites
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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Structural service delivery intervention
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NO_INTERVENTION: Control
No additional services provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)
Time Frame: Between baseline visit and the V7 follow-up visit at 7 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Seroconversion
Time Frame: 12 months
|
This outcome will be assessed in participants who were HIV-negative at baseline, at follow-up time points. The score is based biomarker testing, and ranges from 0 to 1 with higher scores indicating adverse outcome. Participants who remain HIV seronegative at follow-up visits are counted and assigned a score=0; those who seroconvert for HIV 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. |
12 months
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HCV Seroconversion
Time Frame: 12 months
|
This outcome will be assessed in participants who were HCV seronegative at baseline, at follow-up time points. The score is based biomarker testing, and ranges from 0 to 1 with higher scores indicating adverse outcome. Participants who remain HCV seronegative at follow-up visits score=0, those who seroconvert for HCV score=1. |
12 months
|
HIV Care Continuum
Time Frame: 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 the prior 30 days and did not have a visit with an HIV care provider 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 score will be factored into the primary composite outcome. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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HIV Testing
Time Frame: 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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Pre-exposure Prophylaxis (PrEP) Continuum
Time Frame: 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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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HCV Care Continuum
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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HCV Testing
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 score will be factored into the primary composite outcome. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Medication for Opioid Use Disorder (MOUD) Use
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Syringe Service Program (SSP) Use
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Naloxone Overdose Kit
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 into the primary composite outcome. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Injection Drug Use
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Recent Drug Use
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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, heroin, cocaine, or amphetamines. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Sharing Injection Equipment
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 score will be factored into the primary composite outcome. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Non-fatal Overdose
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 adverse outcome. Participants who do not report a non-fatal drug overdose in the prior 6 months are counted and assigned a score=0; those who report a non-fatal drug overdose 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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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Emergency Department (ED) Use
Time Frame: Between 6 months prior to and the V7 follow-up visit at 7 months
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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 adverse outcome. Participants with no ED visits in the prior 6 months are counted and assigned a score=0; those with 1 or more ED visits in 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. |
Between 6 months prior to and the V7 follow-up visit at 7 months
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HIV Seroconversion
Time Frame: Between baseline visit and the V7 follow-up visit at 7 months
|
This outcome will be assessed in participants who were HIV-negative at baseline, at follow-up time points. The score is based biomarker testing, and ranges from 0 to 1 with higher scores indicating adverse outcome. Participants who remain HIV seronegative at follow-up visits are counted and assigned a score=0; those who seroconvert for HIV 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. |
Between baseline visit and the V7 follow-up visit at 7 months
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HCV Seroconversion
Time Frame: Between baseline visit and the V7 follow-up visit at 7 months
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This outcome will be assessed in participants who were HCV seronegative at baseline, at follow-up time points. The score is based biomarker testing, and ranges from 0 to 1 with higher scores indicating adverse outcome. Participants who remain HCV seronegative at follow-up visits are counted and assigned a score=0, those who seroconvert for HCV 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. |
Between baseline visit and the V7 follow-up visit at 7 months
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Mortality Rate
Time Frame: Between baseline visit and the V7 follow-up visit at 7 months
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This outcome will be assessed in all participants at all follow-up time points. The score is based on medical record review or National Death Index, and ranges from 0 to 1 with higher scores indicating adverse outcome. Participants who are alive are counted and assigned a score=0, those who have died 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. |
Between baseline visit and the V7 follow-up visit at 7 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative Assessments
Time Frame: 12 months
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To provide context to our study and identify facilitators and barriers to the intervention, we will conduct qualitative assessments.
First, we will conduct in-depth interviews (IDIs) with ~ 30 PWID participants.
The interview will explore accessibility, coverage, and barriers accessing the services in question.
Second, we will conduct IDIs with Baltimore City Health Department (BCHD) staff who work on either the existing SSP van or the newly created ICV (N~12).
The interview will explore feasibility, perceived benefits and challenges of offering services in the field, and changes in perceptions after intervention roll-out on the ICV.
Third, we will conduct IDIs with BCHD and Maryland Department of Health and Mental Hygiene (DHMH) officials and managers who are involved in PWID services (N~10).
The interview will explore feasibility, and perceived benefits and challenges of offering services in the field on the ICV.
We will digitally record the interviews.
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12 months
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Costs and Cost Effectiveness
Time Frame: 12 months
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In accordance with the recommendations of the 2nd US Panel on Cost-Effectiveness in Heath and Medicine, we will: inventory and value the resources consumed in the ICV intervention; estimate intervention effectiveness in regards to viral suppression, HIV infections averted, HCV treatment, and MAT use; estimate treatment costs averted and Quality-adjusted life years saved for each type of effectiveness; and determine whether the ICV is cost-saving, cost-effective, or not cost-effective.
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12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- IRB00147873
- R01DA045556 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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