Expand routine HIV and Hepatitis C testing at syringe service programs
Project ACCESS: Advancing Access to HIV/HCV Testing Through Transformation in Syringe Services Programs: A Cluster Randomized Trial
This project tests whether giving syringe service programs funding and hands-on practice support helps them offer routine, opt-out HIV and hepatitis C testing and connect people who inject drugs to care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06730555 on ClinicalTrials.gov |
What this trial studies
ACCESS is an organizational-level approach that provides funding and practice facilitation to syringe services programs (SSPs) to build capacity for routine, opt-out HIV and hepatitis C (HCV) screening and linkage to care. Eligible SSPs in designated Ending the HIV Epidemic (EHE) or CDC vulnerable jurisdictions that serve at least 300 unique participants per year will be enrolled and assigned to either the ACCESS intervention or a control group. Participating sites will prospectively report aggregated, site-level counts of participants offered testing, completed tests, and those linked to care, and staff will complete surveys and qualitative interviews during implementation. The study is led by the University of Miami with support from the National Institute on Drug Abuse.
Who should consider this trial
Good fit: People who inject drugs who use participating syringe service programs in EHE or CDC vulnerable jurisdictions where the SSP serves at least 300 unique people per year and does not already offer opt-out HIV/HCV testing.
Not a fit: People who do not use syringe service programs, live outside the eligible jurisdictions, or attend SSPs that already offer opt-out testing are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could increase routine HIV and HCV testing and speed linkage to treatment for people who inject drugs, enabling earlier diagnoses and reducing onward transmission.
How similar studies have performed: Practice facilitation and targeted funding have improved testing uptake in other care settings, but applying this combined approach specifically to SSPs for both HIV and HCV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SSPs must: 1. be operating in an Ending the HIV Epidemic (EHE) or Centers for Disease Control and Prevention (CDC) determined vulnerable jurisdictions; 2. serve at least 300 unique participants per year; 3. not currently offer opt-out HIV/HCV testing; 4. be capable and willing to prospectively collect aggregated, site-level data on the number of participants who are: i) offered HIV/HCV screening, ii) completed these tests, and iii) linked to care, as well as provide participant demographics; 5. have key staff that consent to participate in study surveys, qualitative interviews and practice facilitation throughout the study. Exclusion Criteria: * SSPs must not: 1. currently receive or have received Frontline Communities in the United States (FOCUS) funding; 2. have already implemented opt-out HIV/HCV testing. 3. currently participating in SAIA-SSP-HIV (NCT06025435)
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Tyler Bartholomew, PhD — University of Miami
- Study coordinator: Hansel Tookes, MD
- Email: hetookes@miami.edu
- Phone: 3056897030
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.