Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement Study
NCT ID: NCT05977881
Last Updated: 2026-01-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
500 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-07-28
Study Completion Date
2026-06-30
Brief Summary
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Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention and HIV prevention study among people who use drugs (PWUD). Specifically, SCOPE will provide access to drug-checking services for PWUD to better understand the contents of the drug supply, in combination with PrEP for those who are HIV-, to both reduce overdose and HIV among PWUD in Baltimore City.
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Detailed Description
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specific study aims are:
1. To prepare the drug-checking technology for deployment in the community through a three-phase process.
1. To calibrate drug-checking technology through testing samples of illicit substances on the Bruker Alpha obtained from the Baltimore Police crime lab (N=335) and those obtained through the SPARC outreach sessions (N=100).
2. To validate the drug-checking technology, measuring sensitivity and specificity in detecting illicit substances of public health relevance, by testing samples obtained through partnerships through Baltimore-based harm reduction organizations and comparing findings to the gold standard (laboratory testing).
3. To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR) drug checking machine among People who use drugs (PWUD) (N=20).
2. To develop a community-level, mobile, integrated drug checking and PrEP intervention aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of overdose.
3. To recruit a longitudinal cohort of people who use drugs (N=500) and follow-up at 6-month intervals for 18 months.
4. To implement the intervention and evaluate its impact on engagement in PrEP care (primary outcome) and overdose prevention among PWUD.
1. To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD.
The initial nonhuman subjects research plan focused on Aim's 1 drug checking machine calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr. William Clarke's lab and from individuals interacting with SPARC staff during the outreach which occurs 3-4 times per week. These activities are referred to as "Phase 1" throughout this research plan. Based on emerging best practices and in consultation with other drug checking initiatives nationwide, the investigators have now expanded Aim 1 of the study to include three steps needed to prepare the machine for deployment in the field: The first (1a) was calibration of the machine to the local drug supply, as described above; the second (1b) which the investigators are adding in this amendment is an additional validation of the machine's functionality and comparison with gold standard technology; and the third (1c) is piloting the machine with 20 PWUD prior to rolling it out citywide.
1. To prepare the drug-checking technology for deployment in the community through a three-phase process.
1. To calibrate drug-checking technology through testing samples of illicit substances on the Bruker Alpha obtained from the Baltimore Police crime lab (N=335) and those obtained through the SPARC outreach sessions (N=100).
2. To validate the drug-checking technology, measuring sensitivity and specificity in detecting illicit substances of public health relevance, by testing samples obtained through partnerships through Baltimore-based harm reduction organizations and comparing findings to the gold standard (laboratory testing).
3. To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR) drug checking machine among People who use drugs (PWUD) (N=20).
2. To develop a community-level, mobile, integrated drug checking and PrEP intervention aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of overdose.
3. To recruit a longitudinal cohort of people who use drugs (N=500) and follow-up at 6-month intervals for 18 months.
4. To implement the intervention and evaluate its impact on engagement in PrEP care (primary outcome) and overdose prevention among PWUD.
1. To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD.
The initial nonhuman subjects research plan focused on Aim's 1 drug checking machine calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr. William Clarke's lab and from individuals interacting with SPARC staff during the outreach which occurs 3-4 times per week. These activities are referred to as "Phase 1" throughout this research plan. Based on emerging best practices and in consultation with other drug checking initiatives nationwide, the investigators have now expanded Aim 1 of the study to include three steps needed to prepare the machine for deployment in the field: The first (1a) was calibration of the machine to the local drug supply, as described above; the second (1b) which the investigators are adding in this amendment is an additional validation of the machine's functionality and comparison with gold standard technology; and the third (1c) is piloting the machine with 20 PWUD prior to rolling it out citywide.
Conditions
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HIV Infections
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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SCOPE Cohort
A cohort of PWUD (N=500) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=125/zone). The four recruitment zones will overlap the intervention sites. There will be four study visits (baseline, 6 months, 12 months, 18 months) total for participants.
Group Type
OTHER
CHECKIT!
Intervention Type
OTHER
Participants will not be assigned to the intervention as it will be available to everyone.
Check it will be a van-based HIV- and overdose-prevention program offered in the four areas of Baltimore city from which study participants are recruited. Intervention services will include point-of-care drug checking and PrEP assessment, prescription, and management, and they will be available to everyone, regardless of whether they are part of the SCOPE study cohort or not.
Individual-level service usage data collected by intervention staff will not be considered in analysis of outcomes. However, study participants will self-report Check it utilization on the internally-developed surveys at 6, 12, and 18 months.
Interventions
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CHECKIT!
Participants will not be assigned to the intervention as it will be available to everyone.
Check it will be a van-based HIV- and overdose-prevention program offered in the four areas of Baltimore city from which study participants are recruited. Intervention services will include point-of-care drug checking and PrEP assessment, prescription, and management, and they will be available to everyone, regardless of whether they are part of the SCOPE study cohort or not.
Individual-level service usage data collected by intervention staff will not be considered in analysis of outcomes. However, study participants will self-report Check it utilization on the internally-developed surveys at 6, 12, and 18 months.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 18 years or older,
* self-reports having used illicit stimulants or opioids at least once in the past 3 months,
* self-reports being HIV negative
* reports injection drug use in the past 6 months OR reports at least one of the following indicators of sexual HIV risk exposure in the past 6 months:
1. Sexually Transmitted Infection (STI) diagnosis in the past 6 months
2. "Condom-less" vaginal or anal sex in the past 6 months
* Willing to provide a urine sample for urine drug screening of substances
* Willing to undergo rapid HIV testing
* Willing to undergo STI testing
* self-reports having used illicit stimulants or opioids at least once in the past 3 months,
* self-reports being HIV negative
* reports injection drug use in the past 6 months OR reports at least one of the following indicators of sexual HIV risk exposure in the past 6 months:
1. Sexually Transmitted Infection (STI) diagnosis in the past 6 months
2. "Condom-less" vaginal or anal sex in the past 6 months
* Willing to provide a urine sample for urine drug screening of substances
* Willing to undergo rapid HIV testing
* Willing to undergo STI testing
Exclusion Criteria
* Determined to be too high or drunk or cognitively impaired, less than 18 years of age
* unwilling to provide all required biological specimens (Phase 3 only)
* unwilling/unable to give consent
* unwilling to provide all required biological specimens (Phase 3 only)
* unwilling/unable to give consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Baltimore City Health Department
OTHER
Sponsor Role
collaborator
National Institute on Drug Abuse (NIDA)
NIH
Sponsor Role
collaborator
Johns Hopkins Bloomberg School of Public Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Susan Sherman, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Johns Hopkins School of Public Health
Baltimore, Maryland, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Related Links
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https://www.nih.gov/news-events/news-releases/substance-use-disorders-linked-covid-19-susceptibility
National Institutes of Health. Substance Use Disorders Linked to Covid-19 Susceptibility
Other Identifiers
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IRB00017498
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE3
Packaging PrEP to Prevent HIV Among WWID
NCT03304912
COMPLETED
An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.
NCT06316089
NOT_YET_RECRUITING
NA
Implementing PrEP for Women Who Inject Drugs
NCT05360849
RECRUITING
NA
Peer-driven Intervention on PrEP
NCT05161663
COMPLETED
NA
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
NCT02869776
COMPLETED
NA
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
NCT03058835
ACTIVE_NOT_RECRUITING
PHASE4