Building on Needle Exchange to Optimize Prevention & Treatment

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.

Time frame: Between baseline visit and the V7 follow-up visit at 7 months

Population: 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.

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.

Time frame: 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 counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: Subset includes HCV-positive participants (including viremic or non-viremic with treatment completion) who completed the V7 follow-up visit

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.

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 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.

Time frame: Between baseline visit and the V7 follow-up visit at 7 months

Population: Subset of population who were HCV-negative at baseline and completed a V7 follow-up visit.

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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: 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.

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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: Subset includes HIV-positive participants who completed the V7 follow-up visit.

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.

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.

Time frame: Between baseline visit and the V7 follow-up visit at 7 months

Population: Subset of participants who were HIV-negative at baseline and completed the V7 follow-up visit

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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: Subset of participants who were HIV-negative at both baseline and V7 follow-up visits and completed the V7 follow-up visit.

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.

Time frame: 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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

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.

Time frame: Between baseline visit and the V7 follow-up visit at 7 months

Population: Subset of participants who completed the V7 follow-up visit and participants who died prior to completing the V7 follow-up visit.

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.

Time frame: 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 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.

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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: Subset of participants who were HIV-negative and completed the V7 follow-up visit.

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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

Population: 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.

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.

Time frame: 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.

Time frame: Between 6 months prior to and the V7 follow-up visit at 7 months

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.

Time frame: 12 months

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.

Time frame: 12 months

Population: Participants who completed qualitative in-depth interviews