STORC: Training a support person plus patient navigation after birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study has two phases: a developmental R61 phase to create and pilot test a digital training program for support persons and a patient-navigation approach, followed by a larger R33 randomized trial at two sites. The R61 phase includes creating training materials, pilot testing recruitment procedures, and gathering feedback from participants and stakeholders. The program will be refined into a final digital product based on qualitative input from experts with lived experience. In the pilot phase, 20 individuals (10 patient/support person pairs) will participate to assess feasibility and acceptability and to inform refinements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* must be biological females
* must be currently within 6 weeks postpartum
* must be able to read, write, and speak English at a 6th-grade level
* must be diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder at the PROUD clinic
* must identify a support person who also consents to participate. Patient participants must identify prospective support persons in order to complete consent

Exclusion Criteria:

* pregnancy
* planned discharge to a long-term inpatient care facility (e.g., hospice)
* hospitalization for a suicide attempt
* major mental health disorder that requires treatment before OAT can be considered
* stillbirth or neonatal death of the index pregnancy/infant, as determined from the obstetric record.

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Karen Alexander — Friends Research Institute, Inc.
• Study coordinator: Karen Alexander, PhD
• Email: kalexander@friendsresearch.org
• Phone: 9084510141

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.