Building on Needle Exchange to Optimize Prevention & Treatment

HIV/AIDS Clinical Trial

Official title:

Building on Needle Exchange to Optimize Prevention & Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567174
• Other study ID #: IRB00147873
• Secondary ID: R01DA045556
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: August 2, 2022

Study information

• Verified date: November 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: August 2, 2022
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Intravenous Drug Usage

Intervention

Other:
• Integrated care van (ICV)
Structural service delivery intervention

Locations

Country	Name	City	State
United States	Baltimore City Syringe Service Program Neighborhood sites	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Baltimore City Health Department, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Assessments	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.	12 months
Other	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
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.	Between baseline visit and the V7 follow-up visit at 7 months
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Between baseline visit 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.	12 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.	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 score=0, those who seroconvert for HCV score=1.	12 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.	Between baseline visit and the V7 follow-up visit at 7 months