Recruiting

ACCESS Strategy

Sponsor:

University of Miami

Code:

NCT06730555

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ACCESS Intervention

Control Group

Study Details

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).

Conditions

HIV Infections

Study ID

NCT06730555

Start date

Jun 27, 2025

Status verified date

Sep, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: ACCESS Group

Participants in this group will receive the ACCESS intervention for up to 18 months

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.

Interventions

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.

Control Group

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

Primary outcome measure

  • Number of SSP participants reached [ Time Frame: up to 18 months ]
  • Adoption [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tyler Bartholomew, PhD

3056897030tsb61@miami.edu

Principal Investigator:

Hansel Tookes, MD

More Information

Sponsor

University of Miami

Last update posted

Feb 3, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-02-03.