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

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05977881

Collaborator

National Institutes of Health (NIH) (NIH), Baltimore City Health Department (Other), National Institute on Drug Abuse (NIDA) (NIH)

600

Enrollment

Location

Arm

35.1

Anticipated Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: CHECKIT!	N/A

Detailed Description

specific study aims are:

To prepare the drug-checking technology for deployment in the community through a three-phase process.
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).
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).
To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR) drug checking machine among People who use drugs (PWUD) (N=20).
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.
To recruit a longitudinal cohort of people who use drugs (N=600) and follow-up at 6-month intervals for 18 months.
To implement the intervention and evaluate its impact on engagement in PrEP care (primary outcome) and overdose prevention among PWUD.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 28, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: SCOPE Cohort A cohort of PWUD (N=600) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=120/zone). The five recruitment zones will overlap the intervention sites. There will be 4 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 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.

Arm

Intervention/Treatment

Other: SCOPE Cohort

A cohort of PWUD (N=600) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=120/zone). The five recruitment zones will overlap the intervention sites. There will be 4 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 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.

Outcome Measures

Primary Outcome Measures

Current PrEP status as assessed by study team instrument items [Measured at Baseline, 6, 12, and 18 months]
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.
Change in PrEP uptake as assessed by study team instrument items [Measured at 6, 12, 18 months]
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).

Secondary Outcome Measures

Change in HIV Risk Behaviors as assessed by study team instrument items [Measured at Baseline, 6, 12, 18 months]
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?'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Sexually Transmitted Infection (STI) diagnosis in the past 6 months
"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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Public Health	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

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

Investigators

Principal Investigator: Susan Sherman, PhD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT05977881

Other Study ID Numbers:

00017498
5R01DA053184

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johns Hopkins Bloomberg School of Public Health

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Aug 7, 2023