Pilot Testing of the emPath Platform to Improve Medication for Opioid Use Disorder (MOUD) Linkage and Retention Among Adults With Opioid Use Disorder in Durham, North Carolina

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

This pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Screen positive for moderate to high risk opioid use by WHO-ASSIST

Not currently prescribed any form of MOUD

Able to speak and understand English

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • emPath Intervention

    Behavioral

    Community-partnered telemedicine platform providing registration, video visits, messaging, and low-barrier MOUD access.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: emPath InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

feasibility, as measured by retention in care

Retention in care is defined by at least one virtual visit conducted before and after the expected 3- or 6-month timepoint from enrollment, whichever later timepoint is available based on the participant's timing of enrollment during the study period.

Time frame
up to 6 month visit

Secondary outcomes

1

acceptability

Surveys (intervention acceptability, appropriateness, fidelity) Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the acceptability of intervention measure (AIM).

Time frame
3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete
2

appropriateness

Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the intervention appropriateness measure (IAM)

Time frame
3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes
3

intervention fidelity

To measure implementation protocol fidelity, staff will complete in a baseline survey and 6-month assessment several items related to their contributions to program activities, roles and responsibilities in relation to the implementation protocol.

Time frame
Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes
4

Intervention reach, as measured by weekly and monthly rates of participant platform feature engagement (dashboard, messaging, queue, video portal)

Time frame
From enrollment through the end of the study period, up to 12 months

Other outcomes

Sponsors and contacts

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