Back to search results

Preconception Intervention for Incarcerated Women With Substance Use

This study is testing a program called CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) for incarcerated women with substance use disorders. The program involves four counseling sessions and one family planning session. Researchers want to see if CHOICES-PLEAS can lower the risk of substance-exposed pregnancies after women are released from jail. They will measure this risk one and three months after release. You may be able to join if you are a woman between 18 and 49, can become pregnant, and have had vaginal sex with a male partner in the last three years. The study is currently recruiting 90 participants.

Study design
This study will involve 90 women who will be randomly assigned to receive either the CHOICES-PLEAS intervention or brief advice and referral. It is an interventional study, but the phase is not specified.
What's involved
Participants will receive four manual-guided motivational interviewing sessions and one family planning counseling session while incarcerated.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one and three months after release from jail to assess changes in substance use and risky sexual behaviors.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05854836

Preconception Intervention for Incarcerated Women With Substance Use

Recruiting
NAAges 18–49InterventionalPrevention
St. Louis University
~90 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with a change in risk of substance exposed pregnancy compared to baseline using Timeline Followback method assessing substance use and risky sexual behaviors
Measured over one and three months after release from jail

Conditions

Substance Use Disorders

Explore related trials

Substance use disorder

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Jennifer R Bello Kottenstette, MD · PRINCIPAL_INVESTIGATOR · St. Louis University

Who to contact

Jennifer R Bello Kottenstette, MD
[email protected]
314-617-3445
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with a change in risk of substance exposed pregnancy compared to baseline using Timeline Followback method assessing substance use and risky sexual behaviorsone and three months after release from jail

    Defined as continued drug abstinence, absence of risky sexual behaviors, or both