Substance UseNCT07433712
Project REACH: A Comprehensive Telehealth Intervention at Syringe Service Programs to Engage People Who Use Drugs
A study testing Project REACH in people with Substance Use and Drug Use, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Drug Use
- What is being tested?
- Project REACH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Substance Use, Drug Use
- Being tested
- Project REACH
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project REACHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Project REACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and Retention Rates
Proportion of enrolled participants who complete the study
Measured: Year 2
Comfort Accessing Telehealth Services
Assessed in exit interviews
Measured: Year 2
Uptake of PrEP
EPIC Smartforms
Measured: Year 2
Uptake of MOUD
EPIC Smartforms
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start6 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433712
- Sponsor's protocol ID
- SSP Telehealth R34
- Status last verified
- May 2026
- First submitted
- 19 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project REACH: A Comprehensive Telehealth Intervention at Syringe Service Programs to Engage People Who Use Drugs
- ClinicalTrials.gov ID
- NCT07433712
- Acronym / sponsor ID
- SSP Telehealth R34
- Conditions
- Substance Use, Drug Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project REACH Intervention | Experimental | Other: Project REACHThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project REACHThe 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. | Other | Project REACH Intervention |
Primary outcome
Recruitment and Retention Rates
Time frame: Year 2
Proportion of enrolled participants who complete the study
Comfort Accessing Telehealth Services
Time frame: Year 2
Assessed in exit interviews
Uptake of PrEP
Time frame: Year 2
EPIC Smartforms
Uptake of MOUD
Time frame: Year 2
EPIC Smartforms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project REACH in people with Substance Use and Drug Use, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kumi Smith (612-301-3051, smi00831@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and Retention Rates (time frame: Year 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.