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Recruiting

NCT Number: NCT06730555

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

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).

Recruiting

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Hansel Tookes, MD

PRINCIPAL_INVESTIGATOR

Tyler Bartholomew, PhD

CONTACT

[email protected]

3056897030

Tyler Bartholomew, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ACCESS Intervention

Behavioral

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.

Control Group

Behavioral

Participants will receive a link to the CDC compendium of evidence-based interventions for HIV prevention.

Primary outcomes

  1. 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

  2. Adoption

    Time frame: up to 6 months

    Proportion of SSPs that have created an HIV/HCV opt-out testing policy

Secondary outcomes

  1. Number of SSP participants reached after the intervention

    Time frame: up to 30 months

    Number of total HIV/HCV tests completed divided by the number of unique individuals seen

Study contacts

Contact information is provided by the study sponsor or research team.

Hansel Tookes, MD

CONTACT

[email protected]

3056897030

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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