An interventional study of CHECKIT! in HIV Infections, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
specific study aims are:
To prepare the drug-checking technology for deployment in the community through a three-phase process.
To implement the intervention and evaluate its impact on engagement in PrEP care (primary outcome) and overdose prevention among PWUD.
a. To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD.
To assess changes in drug-related wounds among N=100 PWUD in Baltimore who receive wound care services on the intervention van.
The initial non-human 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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 493 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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.
Current PrEP status as assessed by study team instrument items
Investigators will measure current PrEP status by assessing participant self-report using an internally developed questionnaire. Change in current PrEP status will be measured using three survey items asking participants 1) if they are currently prescribed either form of PrEP (pill form or injection), 2) currently taking/not taking the prescription, and 3) which type/brand of PrEP are they currently taking. The response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. Participants will indicate whether they are currently prescribed PrEP, currently taking PrEP and which type prescribed/taking at each study visit.
Time frame: Measured at Baseline, 6, 12, and 18 months
Change in PrEP uptake as assessed by study team instrument items
Change in PrEP status (uptake) at follow-up is measured using three items with response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. If participants self-report current PrEP use at follow-up, investigators will confirm the biological presence of PrEP using dried blood spot (DBS) sampling. Samples will be transported to the Clinical Pharmacology Analytical Laboratory (CPAL) where they will be processed using FDA-validated assays analyzing drug and metabolite concentrations. Sample results will be used to compare participant self-report on the study team survey instrument (e.g., what is the concordance/discordance between PrEP presence in DBS samples and yes/no responses to the currently taking PrEP survey item).
Time frame: Measured at 6, 12, 18 months
Change in HIV Risk Behaviors as assessed by study team instrument items
Investigators will measure change in HIV risk behaviors using self-report with an internally developed questionnaire; there are several items in the instrument to capture 1) episodes of syringe sharing in the prior 30 days and 2) episodes of unprotected vaginal or anal intercourse. Response options for HIV risk behaviors are continuous (counts # of times of episodes) and response options for HIV prevention techniques used are nominal; e.g., 'used a condom with my main sexual partner', or 'take HIV PrEP', or, 'did you use syringes after someone else?'.
Time frame: Measured at Baseline, 6, 12, 18 months
Plan to share: Yes — Project de-identified IPD will made available for published analyses upon request. The investigators will also include the study protocol (IPD supporting information).
Supporting information: Study protocol
Time frame: The time frame is for the project's IPD/supporting information is 'Unending'; the investigators will consider requests for data related to the project up to five years after publication.
Access criteria: To access project IPD and supporting information, the investigators will consider requests for data from other researchers (university or governmental). The PI will review all requests, approve, and provide IPD access when appropriate.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health →