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

NCT ID: NCT06730555

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2028-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ACCESS Group

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

Group Type EXPERIMENTAL

ACCESS Intervention

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Control Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Tyler Scott Bartholomew

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tyler Bartholomew, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hansel Tookes, MD

Role: CONTACT

3056897030

Facility Contacts

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Tyler Bartholomew, PhD

Role: primary

3056897030

Other Identifiers

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R01DA060462

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20240611

Identifier Type: -

Identifier Source: org_study_id

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