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

HIV Infections Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977881
• Other study ID #: 00017498
• Secondary ID: 5R01DA053184
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Miles Morris, MPH
• Phone: 410-502-4435
• Email: mmorr100[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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=600) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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 5 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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Public Health	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Baltimore City Health Department, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at Baseline, 6, 12, and 18 months
Primary	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).	Measured at 6, 12, 18 months
Secondary	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?'.	Measured at Baseline, 6, 12, 18 months

External Links

•   Centers for Disease Control and Prevention. Overdose Deaths Accelerating during Covid-19.
•   National Institutes of Health. Substance Use Disorders Linked to Covid-19 Susceptibility