NCT07433712

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026May 2028

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

February 19, 2026

Last Update Submit

May 18, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Project REACH Intervention

EXPERIMENTAL

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

Interventions

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.

Project REACH Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • 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
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations