NCT06730555

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
28mo left

Started Jun 2025

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2025Aug 2028

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

June 27, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 3, 2026

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

December 9, 2024

Last Update Submit

January 30, 2026

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

  • Number of SSP participants reached

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

    up to 18 months

  • Adoption

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

    up to 6 months

Secondary Outcomes (1)

  • Number of SSP participants reached after the intervention

    up to 30 months

Study Arms (2)

ACCESS Group

EXPERIMENTAL

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

Behavioral: ACCESS Intervention

Control Group

ACTIVE COMPARATOR

Participants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months.

Behavioral: Control Group

Interventions

ACCESS InterventionBEHAVIORAL

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.

ACCESS Group
Control GroupBEHAVIORAL

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tyler Bartholomew, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hansel Tookes, MD

CONTACT

3056897030hetookes@miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

June 27, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 3, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)