CompletedNot Applicable

Piloting a Web Resource for Pregnancy OUD in Jail

United States22 participantsStarted 2024-05-14

Plain-language summary

The goal of this clinical trial is to pilot an adaptable, user-friendly, web-accessible toolkit and implementation strategy for jails to be able to provide access to pregnancy-specific opioid use disorder (OUD) care. The main question it aims to answer is: \- What support and tools do jails that vary in size, resources, and health care delivery systems need for pregnancy care that can be tailored to the environment? Jail staff will use the implementation resource to provide care to pregnant people in and leaving custody through facilitated guidance. While using the resource, jail staff will: * Complete 6-month and 12-month surveys assessing the participants use of the tool * Complete baseline, 6-month, and 12-month qualitative interviews assessing the participants perspectives on using the tool * Report de-identified jail outcomes data monthly on the pregnant people in the jail's care * Report jail policy and financial data as it pertains to pregnant people with OUD at baseline Pregnant people with OUD in custody at pilot jails will be asked to participate in qualitative interviews as baseline and 1- and 6 months after release to assess the participants perspectives on the care received in jail and continuity of care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Jail staff Inclusion: * Jail custody staff who are employed at a jail that holds pregnant women with OUD and are involved in the care of pregnant women with opioid use disorder Exclusion: * non-English speaking Pregnant people with opioid use disorder Inclusion: * pregnant people with OUD who are in custody at a pilot jail during the study period * jail stay of at least 24 hours Exclusion: * non-English speaking * women who are intoxicated or actively withdrawing * women are actively psychotic

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in organizational readiness as assessed by the ORIC scale

Timeframe: Baseline, 6 months, 12 months

Change in technology usage, attitudes and satisfaction as assessed by the UTAUT

Timeframe: 6 months, 12 months

Satisfaction, autonomy, discrimination and other experiences for pregnant people with OUD (PPwOUD) in jail as assessed by the RRDS

Timeframe: Post release from jail up to 1 month

Trial details

NCT IDNCT05853289

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-21

View on ClinicalTrials.gov More Opioid Use Disorder trials