Project ACCESS: Advancing Access to HIV/HCV Testing Through Transformation in Syringe Services Programs: A Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of SSP participants reached
Study Overview
Brief Summary
The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •SSPs must:
- •be operating in an Ending the HIV Epidemic (EHE) or Centers for Disease Control and Prevention (CDC) determined vulnerable jurisdictions;
- •serve at least 300 unique participants per year;
- •not currently offer opt-out HIV/HCV testing;
- •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;
- •have key staff that consent to participate in study surveys, qualitative interviews and practice facilitation throughout the study.
Exclusion Criteria
- •SSPs must not:
- •currently receive or have received Frontline Communities in the United States (FOCUS) funding;
- •have already implemented opt-out HIV/HCV testing.
- •currently participating in SAIA-SSP-HIV (NCT06025435)
Arms & Interventions
ACCESS Group
Participants in this group will receive the ACCESS intervention for up to 18 months
Intervention: ACCESS Intervention (Behavioral)
Control Group
Participants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months.
Intervention: Control Group (Behavioral)
Outcomes
Primary Outcomes
Number of SSP participants reached
Time Frame: up to 18 months
Number of total HIV/HCV tests completed divided by the number of unique individuals seen
Adoption
Time Frame: up to 6 months
Proportion of SSPs that have created an HIV/HCV opt-out testing policy
Secondary Outcomes
- Number of SSP participants reached after the intervention(up to 30 months)
Investigators
Tyler Scott Bartholomew
Associate Professor
University of Miami