Project REACH: A Comprehensive Telehealth Intervention at Syringe Service Programs to Engage People Who Use Drugs

May 18, 2026 updated by: University of Minnesota
This trial will assess the feasibility, acceptability, and preliminary effectiveness of Project REACH (Remote Engagement & Access for Community Health), a telehealth intervention at syringe service programs (SSP) to improve access to HIV-related evidence-based interventions (EBI) for people who use drugs including those who inject them.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

People Who Use Drugs Inclusion Criteria:

  • 18 years of age or older
  • able to speak and understand English
  • have used an illicit substance at least once in the past year
  • have lived in the study area (in or near their city of their recruitment) for at least 6 months
  • have active health insurance by the start of the Project REACH trial date

People Who Use Drugs Exclusion Criteria:

  • Unable or unwilling to provide informed consent

Stakeholder Inclusion Criteria:

  • 18 years of age or older
  • able to speak and understand English
  • currently employed or volunteering with the PCC or an SSP enrollment site for at least one year at the time of the interview OR hired as a study navigator at one of the four enrollment sites

Stakeholder Exclusion Criteria:

  • Unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Project REACH Intervention
The primary interactions with participants of Project REACH will consist of syringe service program (SSP)-based recruitment and enrollment, provision of telehealth services at SSPs for the 6-month pilot duration, and exit interviews with a subset of participants and SSP study staff following the trial.
Other: Project REACH
The primary interactions with participants of Project REACH will consist of SSP-based recruitment and enrollment, provision of telehealth services at SSPs for the 6-month pilot duration, and exit interviews with a subset of participants and SSP study staff following the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment and Retention Rates
Time Frame: Year 2
Proportion of enrolled participants who complete the study
Year 2
Comfort Accessing Telehealth Services
Time Frame: Year 2
Assessed in exit interviews
Year 2
Uptake of PrEP
Time Frame: Year 2
EPIC Smartforms
Year 2
Uptake of MOUD
Time Frame: Year 2
EPIC Smartforms
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSP Telehealth R34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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