Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA045556 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Baltimore City Health Department | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | No additional services provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated care van (ICV) | Other | Structural service delivery intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Care Continuum | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Completed Qualitative Assessments | To provide context and identify facilitators and barriers to the intervention, investigators will conduct qualitative assessments. First, investigators will conduct in-depth interviews (IDIs) with ~ 30 PWID participants. The interview will explore accessibility, coverage, and barriers accessing the services in question. Second, investigators 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, 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. Investigators will digitally record the interviews. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory M Lucas, MD | Johns Hopkins University | Principal Investigator |
| Kathleen Page, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore City Syringe Service Program Neighborhood sites | Baltimore | Maryland | 21205 | United States |
Willing to share de-identified Individual Participant Data (IPD) with researchers that approach our team with an acceptable proposal.
Not provided
Not provided
Not provided
Not provided
19 syringe service program (SSP) sites from Baltimore City Health Department were considered for the trial. The 13 sites with the largest numbers of clients in 2017 were initially selected, and one of those 13 was eliminated because it already offered some services planned for the intervention. The remaining 12 sites were paired based on client demographics, SSP client non-overlap between sites, and SSP staff opinions about the similarities of sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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, hepatitis C virus (HCV) testing, Pre-Exposure Prophylaxis (PrEP), Medication-Assisted Treatment (MAT), wound care, case work services, on-site medical management and linkage. Integrated care van (ICV): Structural service delivery intervention |
| FG001 | Control | No additional services provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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, hepatitis C virus (HCV) testing, Pre-Exposure Prophylaxis (PrEP), Medication-assisted Treatment (MAT), wound care, case work services, on-site medical management and linkage. Integrated care van (ICV): Structural service delivery intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subset of participants who had calculated composite outcome scores at the V7 visit: participants who either completed the V7 follow-up visit or died before completing the V7 follow-up visit. | Posted | Mean | Standard Deviation | units on a scale | Between baseline visit and the V7 follow-up visit at 7 months |
|
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).
These research procedures are minimal risk (involve only a blood draw), do not include a drug or medical device, and the intervention was being rolled out by the BCHD. Finally, the study population (active PWID) have relatively high rates of mortality and morbidity compared to the general public. Given these considerations, our reporting obligations for the trial focus only on events that are more likely than not to be associated with study procedures (study visits or key-informant interviews).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Integrated care van (ICV): Structural service delivery intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory M. Lucas | Johns Hopkins University | 410 614 0560 | glucas@jhmi.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2022 | Nov 18, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Cluster-randomized trial
Not provided
Not provided
Not provided
Not provided
| Between 6 months prior to and the V7 follow-up visit at 7 months |
| HIV Testing | 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 |
| Pre-exposure Prophylaxis (PrEP) Continuum | 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 |
| HCV Care Continuum | 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 |
| HCV Testing | 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 |
| Medication for Opioid Use Disorder (MOUD) Use | 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 |
| Syringe Service Program (SSP) Use | 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 |
| Naloxone Overdose Kit | 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 |
| Injection Drug Use | 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 |
| Recent Drug Use | 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 |
| Sharing Injection Equipment | 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 |
| Non-fatal Overdose | 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 |
| Emergency Department (ED) Use | 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 |
| HIV Seroconversion | 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 |
| HCV Seroconversion | 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 |
| Mortality Rate | 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 |
| 12 months |
| Costs and Cost Effectiveness | 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. | 12 months |
| BG001 | Control | No additional services provided. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes) | 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 score, points are allocated on the basis of failure to access evidence-based services, riskier behaviors, and adverse outcomes. 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. | Mean | Standard Deviation | units on a scale |
|
| Description |
|---|
| OG000 | 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. Integrated care van (ICV): Structural service delivery intervention |
| OG001 | Control | No additional services provided. |
|
|
|
| Secondary | HIV Care Continuum | 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. | Subset includes HIV-positive participants who completed the V7 follow-up visit. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | HIV Testing | 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. | Subset of participants who were HIV-negative at both baseline and V7 follow-up visits and completed the V7 follow-up visit. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Pre-exposure Prophylaxis (PrEP) Continuum | 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. | Subset of participants who were HIV-negative and completed the V7 follow-up visit. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | HCV Care Continuum | 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. | Subset includes HCV-positive participants (including viremic or non-viremic with treatment completion) who completed the V7 follow-up visit | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | HCV Testing | 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. | Subset includes HCV-antibody negative participants and HCV-antibody positive participants who spontaneously cleared the infection without completing treatment and completed the V7 follow-up visit. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Medication for Opioid Use Disorder (MOUD) Use | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Syringe Service Program (SSP) Use | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Naloxone Overdose Kit | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Injection Drug Use | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Recent Drug Use | 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. | Subset of participants who completed a V7 follow-up visit and had available urine toxicology result. Two participants did not have urine toxicology results available. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Sharing Injection Equipment | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Non-fatal Overdose | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Emergency Department (ED) Use | 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. | Posted | Count of Participants | Participants | Between 6 months prior to and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | HIV Seroconversion | 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. | Subset of participants who were HIV-negative at baseline and completed the V7 follow-up visit | Posted | Count of Participants | Participants | Between baseline visit and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | HCV Seroconversion | 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. | Subset of population who were HCV-negative at baseline and completed a V7 follow-up visit. | Posted | Count of Participants | Participants | Between baseline visit and the V7 follow-up visit at 7 months |
|
|
|
| Secondary | Mortality Rate | 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. | Subset of participants who completed the V7 follow-up visit and participants who died prior to completing the V7 follow-up visit. | Posted | Count of Participants | Participants | Between baseline visit and the V7 follow-up visit at 7 months |
|
|
|
| Other Pre-specified | Participants Who Completed Qualitative Assessments | To provide context and identify facilitators and barriers to the intervention, investigators will conduct qualitative assessments. First, investigators will conduct in-depth interviews (IDIs) with ~ 30 PWID participants. The interview will explore accessibility, coverage, and barriers accessing the services in question. Second, investigators 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, 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. Investigators will digitally record the interviews. | Participants who completed qualitative in-depth interviews | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Costs and Cost Effectiveness | 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. | Not Posted | 12 months | Participants |
| 24 |
| 360 |
| 24 |
| 360 |
| 0 |
| 360 |
| EG001 | Control | No additional services provided. | 31 | 360 | 31 | 360 | 0 | 360 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Not suppressed, no ARVs and no provider visit last 6 months |
|
| Detectable HCV RNA, have not been treated or evaluated in the prior 6 months |
|
| Shared needle/syringes in the prior 6 months |
|