Optimizing Pregnancy and Treatment Interventions for Moms 3.0

NCT07586917 | Not Yet Recruiting DMC

• 2 other identifiers: 195295U01CE003831
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

We want to learn if Patient Navigation helps pregnant Medicaid members with opioid use disorder, with or without stimulant use disorder, stay in care, use medications for opioid use disorder, reduce substance use, and connect with services, compared to usual care. Enrolled participants will be randomly assigned (by chance, like flipping a coin) to one of two groups: Usual Care or Patient Navigation. Participate will last up to 14 months and participants randomized to Patient Navigation may have about 14 sessions/calls with a Patient Navigator (30-45 minutes each) and complete 3 surveys (30-60 minutes each). All visits can be by phone or video.

Conditions

Opioid Abuse (Disorder); Stimulant Use Disorders

Outcome Measures

Primary Outcomes (1)

• Change in illicit opioid use

  14-panel urine toxicology Timeline Follow Back (TLFB)

  36 months

Study Arms (2)

Usual Care

NO INTERVENTION

This arm includes brief case management and referral.

Patient Navigation

EXPERIMENTAL

The intervention portion consists of sessions delivered in both the participant's prenatal and postnatal period.

Behavioral: Patient Navigation

Interventions

Patient Navigation BEHAVIORAL

The prenatal portion will consist of 7-10 sessions, with the number of sessions received being dependent on the pregnancy week enrolled and the date of delivery. Each session will last 45-60 minutes and will be delivered by a study navigator. Participants who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce recovery, Medication for Opioid Use adherence, and treatment retention. The postnatal portion of the intervention will be delivered in 4 sessions over 8 weeks.

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years)
• Opioid use disorder
• ≥7 weeks gestation
• Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD)
• Provide permission to access administrative claims and medical records of their care and those of their neonate
• Speak English

You may not qualify if:

• Plan to terminate pregnancy
• Had a psychotic and/or manic episode in the last 30 days
• Cannot provide contact information for themselves and 2 collateral contacts
• Do not possess a reliable phone
• Plan to move from the area ≤6 months of delivery
• \>32 weeks gestation

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Grace Sr. Clinical Research Coordinator

CONTACT

385-315-0698; optimom@utah.edu

Kristi Clinical Research Manager

CONTACT

801-213-0799

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)