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Drug-Checking Services + PrEP for HIV Prevention (SCOPE Trial)

N/A
Recruiting
Led By Susan Sherman, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 6, 12, 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will provide drug-checking services and PrEP to people who use drugs in Baltimore to reduce overdose and HIV.

Who is the study for?
This trial is for adults over 18 in Baltimore who use stimulants or opioids, have had unprotected sex recently, are HIV negative, and may have had an STI. They must be willing to undergo drug screening, HIV and STI testing. Those too impaired or unable to consent can't join.
What is being tested?
The SCOPE study is evaluating a program that combines drug-checking services with PrEP (a medication preventing HIV) for people using drugs. The goal is to reduce both overdoses and new HIV infections among participants.
What are the potential side effects?
While the description doesn't list specific side effects, PrEP can sometimes cause nausea, headaches, stomach pain, weight loss and fatigue. Drug-checking services themselves do not involve taking medications but rather assessing substances' safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 6, 12, 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 6, 12, 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PrEP uptake as assessed by study team instrument items
Current PrEP status as assessed by study team instrument items
Secondary study objectives
Change in HIV Risk Behaviors as assessed by study team instrument items

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SCOPE CohortExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,171,618 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,329,369 Total Patients Enrolled
Baltimore City Health DepartmentOTHER
8 Previous Clinical Trials
18,675 Total Patients Enrolled
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
431 Previous Clinical Trials
2,134,696 Total Patients Enrolled
Susan Sherman, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
1 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

SCOPE Cohort Clinical Trial Eligibility Overview. Trial Name: NCT05977881 — N/A
HIV Suppression Research Study Groups: SCOPE Cohort
HIV Suppression Clinical Trial 2023: SCOPE Cohort Highlights & Side Effects. Trial Name: NCT05977881 — N/A
SCOPE Cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977881 — N/A
~146 spots leftby Aug 2025