Clinical trial Recruiting at 1 site Interventional Ages 18 to 49 Women only

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 typeInterventional
Ages18 Years to 49 Years
SexWomen only
Enrollment90 (estimated)
SponsorSt. Louis University
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedDecember 4, 2023
Main results expectedOctober 30, 2026
Study endsMarch 1, 2027
Registry record updatedJuly 23, 2026
Trial IDNCT05854836 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.