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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06730555

Acronym

ACCESS

Enrollment

Registered

2024-12-12

Start date

2025-06-27

Completion date

2028-08-01

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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).

Interventions

BEHAVIORALACCESS 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.

BEHAVIORALControl Group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTHansel Tookes, MD

hetookes@miami.edu3056897030

PRINCIPAL_INVESTIGATORTyler Bartholomew, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026