NCT05977881

Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement Study

Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-28
• Primary completion: 2026-05-01
• Completion: 2026-06-30
• First posted: 2023-08-07
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States