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

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: Substance Use; Drug Use
• Intervention / Treatment: Other: Project REACH

• Study Type: Interventional
• Enrollment (Estimated): 121
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kumi Smith; Phone Number: 612-301-3051; Email: smi00831@umn.edu

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Proportion of enrolled participants who complete the study	Year 2
Comfort Accessing Telehealth Services	Assessed in exit interviews	Year 2
Uptake of PrEP	EPIC Smartforms	Year 2
Uptake of MOUD	EPIC Smartforms	Year 2

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

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: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• 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