Intervention for pregnant women in jail with substance use issues
Official title: A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women
Run by St. Louis University · NCT05854836 · Data updated 2026-11-12
This study is testing a new program for pregnant women in jail with substance use issues to see if it helps them reduce drug use and prevent substance-exposed pregnancies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 49 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | St. Louis University Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | December 4, 2023 |
| Main results expected | October 30, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT05854836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking women capable of becoming pregnant who have a history of substance use and vaginal sex with male partners.
✕Probably not a fit
Patients who have undergone permanent sterilization or are using long-acting reversible contraceptives will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot trial aims to evaluate the feasibility, acceptability, and efficacy of the CHOICES-PLEAS intervention among incarcerated women with substance use disorders. Participants will receive three motivational interviewing sessions and a family planning referral during their 90-day court-mandated treatment program. The study will assess whether this intervention reduces the risk of substance-exposed pregnancies and increases motivation to change substance use behaviors. A total of 90 women will be recruited and randomized into intervention and control groups over a 2.5-year period.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of substance-exposed pregnancies among incarcerated women.
How similar studies have gone: While similar interventions have been explored, this specific approach targeting incarcerated women with substance use disorders is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * Capable of becoming pregnant (did not undergo a permanent sterilization procedure and not using a highly effective long-acting reversible birth control method, i.e. intrauterine device or implant.) * During the three year prior to arrest or entering the treatment program engaged in vaginal sex with a male partner. * During the three months prior to arrest or entering the treatment program used at least one substance (heroin, fentanyl, opioids, cocaine, methamphetamine, or marijuana or alcohol with another substance). * (For women recruited from the MAT Program): Expected length of incarceration at the St. Louis County Jail 2-6 months; expected release into the community. Exclusion Criteria: * Participated in a focus group that was part of the formative work for this study to create the intervention adaptation * Non-English-speaking * Not capable of pregnancy (underwent a permanent sterilization procedure or using a long-acting reversible contraceptive method) * No vaginal sex with a male partner in the 3 years prior to incarceration or entering the treatment program. * No use of an illicit substance, such as only alcohol or marijuana use not in combination with another substance
Where it's running
-
Buzz Westfall Justice Center
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Jennifer R Bello Kottenstette, MD — St. Louis University
- Study coordinator: Jennifer R Bello Kottenstette, MD
- Email: jennifer.bellokottenstette@health.slu.edu
- Phone: 314-617-3445
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder
This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.
-
Effects of comorbidity on people with severe mental illness
This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.
-
Interdisciplinary support to smooth care transitions for hospitalized adults with substance use disorders
This study tests a team-based in-hospital and post-discharge program to help adults with substance use disorders move from hospital care to ongoing community treatment.
-
Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) for re-entry
This trial tests a multicomponent program called MISSION-CJ with Peer Linkage Support to help adults released from two Massachusetts jails who have both mental health and substance use disorders.
-
Helping toddlers of caregivers with substance use disorders build language skills with group and individualized parenting supports
This project will test whether adding coaching and one-on-one lessons to a group parenting program helps toddlers (12–42 months) of caregivers with substance use disorders develop better language skills.
-
Recovery Inspired Support Engagement: A 12‑week 1-on-1 program for families and friends supporting someone in recovery
A 12‑week telehealth program will test whether a one‑on‑one support program for people who support loved ones in substance use recovery is doable and acceptable.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.