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Recruiting NCT06730555

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

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACCESS Intervention, Control Group.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Number of SSP participants reached [Time frame: up to 18 months]
  • Adoption [Time frame: up to 6 months]
Secondary outcome measures (1)
  • Number of SSP participants reached after the intervention [Time frame: up to 30 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06730555 · 20240611 · R01DA060462

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗