Trial Outcomes & Findings for Building on Needle Exchange to Optimize Prevention & Treatment (NCT NCT03567174)

NCT ID: NCT03567174

Last Updated: 2026-02-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 720 participants
• Primary outcome timeframe: Between baseline visit and the V7 follow-up visit at 7 months
• Results posted on: 2026-02-09

Participant Flow

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.

Unit of analysis: Study Sites

Participant milestones

Measure	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	Control No additional services provided.
Overall Study STARTED	360 6	360 6
Overall Study V7 Follow-up	268 6	243 6
Overall Study V14 Follow-up (Pre-COVID)	79 2	70 2
Overall Study COVID Phone Surveys	164 6	155 6
Overall Study V14 Follow-up (Post-COVID)	92 4	85 4
Overall Study COMPLETED	171 6	155 6
Overall Study NOT COMPLETED	189 0	205 0

Reasons for withdrawal

Measure	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	Control No additional services provided.
Overall Study Death	24	31
Overall Study Lost to Follow-up	165	174

Baseline Characteristics

Building on Needle Exchange to Optimize Prevention & Treatment

Baseline characteristics by cohort

Measure	Integrated Care Van (ICV) n=360 Participants 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	Control n=360 Participants No additional services provided.	Total n=720 Participants Total of all reporting groups
Age, Continuous	51.5 years n=362 Participants	48 years n=3 Participants	50 years n=7 Participants
Sex/Gender, Customized Male	226 Participants n=362 Participants	218 Participants n=3 Participants	444 Participants n=7 Participants
Sex/Gender, Customized Female	134 Participants n=362 Participants	142 Participants n=3 Participants	276 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=362 Participants	10 Participants n=3 Participants	17 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	352 Participants n=362 Participants	350 Participants n=3 Participants	702 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=362 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=362 Participants	4 Participants n=3 Participants	8 Participants n=7 Participants
Race (NIH/OMB) Asian	2 Participants n=362 Participants	1 Participants n=3 Participants	3 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=362 Participants	2 Participants n=3 Participants	3 Participants n=7 Participants
Race (NIH/OMB) Black or African American	270 Participants n=362 Participants	253 Participants n=3 Participants	523 Participants n=7 Participants
Race (NIH/OMB) White	75 Participants n=362 Participants	88 Participants n=3 Participants	163 Participants n=7 Participants
Race (NIH/OMB) More than one race	8 Participants n=362 Participants	11 Participants n=3 Participants	19 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=362 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants
Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)	7.32 units on a scale STANDARD_DEVIATION 1.75 • n=362 Participants	7.37 units on a scale STANDARD_DEVIATION 1.94 • n=3 Participants	7.35 units on a scale STANDARD_DEVIATION 1.85 • n=7 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Integrated Care Van (ICV) n=272 Participants 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	Control n=250 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Composite PWID Score (Service Access, Risk Behaviors, Adverse Outcomes)	5.34 units on a scale Standard Deviation 2.35	5.64 units on a scale Standard Deviation 2.56	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=32 Participants 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	Control n=33 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HIV Care Continuum Not suppressed, ARVs in prior 30 days or provider visit last 6 months	18 Participants	10 Participants	—
HIV Care Continuum Suppressed (HIV RNA undetectable)	13 Participants	19 Participants	—
HIV Care Continuum Not suppressed, no ARVs and no provider visit last 6 months	1 Participants	4 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=236 Participants 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	Control n=210 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HIV Testing Had an HIV test in the prior 6 months	234 Participants	202 Participants	—
HIV Testing Did not have an HIV test in the prior 6 months	2 Participants	8 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=236 Participants 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	Control n=210 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Pre-exposure Prophylaxis (PrEP) Continuum Used PrEP in the prior 6 months	0 Participants	4 Participants	—
Pre-exposure Prophylaxis (PrEP) Continuum Did not use PrEP in the prior 6 months	236 Participants	206 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=145 Participants 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	Control n=103 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HCV Care Continuum Successfully treated for HCV with undetectable HCV RNA	34 Participants	20 Participants	—
HCV Care Continuum Detectable HCV RNA but who have been evaluated or treated for HCV in the prior 6 months	36 Participants	25 Participants	—
HCV Care Continuum Detectable HCV RNA, have not been treated or evaluated in the prior 6 months	75 Participants	58 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=122 Participants 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	Control n=139 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HCV Testing Had an HCV test in the prior 6 months	65 Participants	66 Participants	—
HCV Testing Did not have an HCV test in the prior 6 months	57 Participants	73 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Medication for Opioid Use Disorder (MOUD) Use Used MOUD in the prior 6 months	165 Participants	134 Participants	—
Medication for Opioid Use Disorder (MOUD) Use Have not used MOUD in the prior 6 months	103 Participants	109 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Syringe Service Program (SSP) Use Used an SSP in the prior 6 months	223 Participants	208 Participants	—
Syringe Service Program (SSP) Use Did not use an SSP in the prior 6 months	45 Participants	35 Participants	—

SECONDARY outcome

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

This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 1 with higher scores indicating poorer engagement in risk reduction services.

Participants who possess a naloxone overdose kit that is usually accessible when they use drugs (i.e, where they usually use drugs) are counted and assigned a score=0; those who do not possess a naloxone overdose kit that is in an accessible location are counted and assigned score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Naloxone Overdose Kit Possess a naloxone overdose kit that is in an accessible location (where they usually use drugs)	164 Participants	157 Participants	—
Naloxone Overdose Kit Do not possess a naloxone overdose kit that is usually accessible when they use drugs	104 Participants	86 Participants	—

SECONDARY outcome

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

This outcome will be assessed in all participants at all time points. The score is based on self-report and ranges from 0 to 1 with higher scores indicating riskier behavior.

Participants who did not inject drugs in the prior 6 months are counted and assigned a score=0; those who did inject drugs in the prior 6 months are counted and assigned a score=1. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Injection Drug Use Did not inject drugs in the prior 6 months	108 Participants	85 Participants	—
Injection Drug Use Did inject drugs in the prior 6 months	160 Participants	158 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=267 Participants 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	Control n=242 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Recent Drug Use Have a positive urine drug test for selected drugs	225 Participants	217 Participants	—
Recent Drug Use Have a negative urine drug test for selected drugs	42 Participants	25 Participants	—

SECONDARY outcome

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

This outcome will be assessed in all participants at all time points. The score is based on self-report and ranges from 0 to 2 with higher scores indicating riskier behavior.

Participants who did not share needle/syringe or cotton/cooker in the prior 6 months are counted and assigned a score=0; those who shared cotton/cooker but did not share needle/syringes in the prior 6 months are counted and assigned a score=1; those who shared needle/syringes in the prior 6 months are counted and assigned a score=2. The counts of participants will be reported for this outcome measure and the associated score will be factored into the primary composite outcome.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Sharing Injection Equipment Did not share needle/syringe or cotton/cooker in the prior 6 months	202 Participants	175 Participants	—
Sharing Injection Equipment Shared cotton/cooker but did not share needle/syringes in the prior 6 months	21 Participants	23 Participants	—
Sharing Injection Equipment Shared needle/syringes in the prior 6 months	45 Participants	45 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Non-fatal Overdose Do not report a non-fatal drug overdose in the prior 6 months	230 Participants	210 Participants	—
Non-fatal Overdose Report a non-fatal drug overdose in the prior 6 months	38 Participants	33 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=268 Participants 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	Control n=243 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Emergency Department (ED) Use No ED visits in the prior 6 months	166 Participants	144 Participants	—
Emergency Department (ED) Use With 1 or more ED visits in prior 6 months	102 Participants	99 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=237 Participants 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	Control n=211 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HIV Seroconversion HIV seronegative at follow-up visits	236 Participants	210 Participants	—
HIV Seroconversion Seroconvert for HIV	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=88 Participants 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	Control n=111 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
HCV Seroconversion HCV seronegative at follow-up visits	87 Participants	105 Participants	—
HCV Seroconversion Seroconvert for HCV	1 Participants	6 Participants	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Integrated Care Van (ICV) n=272 Participants 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	Control n=250 Participants No additional services provided.	Non-clients This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Mortality Rate Alive	268 Participants	243 Participants	—
Mortality Rate Died	4 Participants	7 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Participants who completed qualitative in-depth interviews

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.

Outcome measures

Measure	Integrated Care Van (ICV) n=18 Participants 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	Control n=16 Participants No additional services provided.	Non-clients n=15 Participants This is a group of individuals who would have been eligible to receive services from the integrated care van intervention but had not engaged in care at that mobile service clinic.
Participants Who Completed Qualitative Assessments	18 Participants	16 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 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.

Outcome measures

Outcome data not reported

Adverse Events

Integrated Care Van (ICV)

Serious events: 24 serious events

Other events: 0 other events

Deaths: 24 deaths

Control

Serious events: 31 serious events

Other events: 0 other events

Deaths: 31 deaths

Serious adverse events

Measure	Integrated Care Van (ICV) n=360 participants at risk 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	Control n=360 participants at risk No additional services provided.
General disorders Death	6.7% 24/360 • Number of events 24 • 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).	8.6% 31/360 • Number of events 31 • 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).

Other adverse events

Adverse event data not reported

Additional Information

Gregory M. Lucas

Johns Hopkins University

Phone: 410 614 0560

Email: glucas@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place