Outreach program for drug checking and HIV prevention
Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade
This study is testing a program that offers drug-checking services and HIV prevention medication to help people who use drugs in Baltimore stay safe and healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05977881 on ClinicalTrials.gov |
What this trial studies
The Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement study aims to reduce overdose and HIV infections among people who use drugs (PWUD) in Baltimore City. It will provide drug-checking services to help PWUD understand the contents of their drug supply while also offering PrEP to those who are HIV-negative. The study involves calibrating and validating drug-checking technology, piloting its use among PWUD, and recruiting a longitudinal cohort to evaluate the intervention's effectiveness over 18 months. The primary outcomes include engagement in PrEP care and overdose prevention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who have used illicit stimulants or opioids in the past three months and are HIV-negative.
Not a fit: Patients who are not engaged in drug use or who are HIV-positive may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of HIV infections and drug overdoses among vulnerable populations.
How similar studies have performed: Other studies have shown success with similar harm reduction approaches, indicating potential for positive outcomes in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Public Health — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Susan Sherman, PhD — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Miles Morris, MPH
- Email: mmorr100@jhu.edu
- Phone: 410-502-4435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.