Advancing Access to HIV/HCV Testing for People Who Inject Drugs (PWID) (ACCESS)

Project ACCESS: Advancing Access to HIV/HCV Testing Through Transformation in Syringe Services Programs: A Cluster Randomized Trial

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 Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: ACCESS Intervention; Behavioral: Control Group

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hansel Tookes, MD; Phone Number: 3056897030; Email: hetookes@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Hansel Tookes, MD
      • Principal Investigator: Tyler Bartholomew, PhD
      • Contact: Tyler Bartholomew, PhD; Phone Number: 3056897030; Email: tsb61@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACCESS Group; Participants in this group will receive the ACCESS intervention for up to 18 months	Behavioral: ACCESS Intervention; Participants will receive the ACCESS intervention with funding, consisting of up to 16 hours of practice facilitation per month in person and/or virtually. Practice facilitation is training and support on implementation of routine HIV/HCV screening.
Active Comparator: Control Group; Participants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months.	Behavioral: Control Group; Participants will receive a link to the CDC compendium of evidence-based interventions for HIV prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SSP participants reached	Number of total HIV/HCV tests completed divided by the number of unique individuals seen	up to 18 months
Adoption	Proportion of SSPs that have created an HIV/HCV opt-out testing policy	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SSP participants reached after the intervention	Number of total HIV/HCV tests completed divided by the number of unique individuals seen	up to 30 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tyler Bartholomew, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 20240611; R01DA060462 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No