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

Not Applicable

Not yet recruiting

• Conditions: HIV Infections

• Registration Number: NCT06730555
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Study Start: 2025-08-01
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of SSP participants reached	up to 18 months	number of SSP participants tested for HIV/HCV divided by the number of SSP participants that should have received HIV/HCV testing
Adopotion	up to 6 months	proportion of trained SSP staff that deliver opt-out testing messaging to 1 or more SSP participant

Secondary Outcome Measures

Name	Time	Method
Number of SSP participants reached after the intervention	up to 30 months	number of SSP participants tested for HIV/HCV divided by the number of SSP participants that should have received HIV/HCV testing
Number of racial minorities reached	up to 18 months	number of racial minority participants tested for HIV/HCV divided by the number of SSP racial minority participants that should have received HIV/HCV testing
Number of gender minorities reached	up to 18 months	number of gender minorities tested for HIV/HCV divided by the number of SSP gender minorities that should have received HIV/HCV testing

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States