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Preconception Intervention for Incarcerated Women With Substance Use

A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women

Who can join

Ages 18 to 49 · Women

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

About the study

The goal of this pilot trial is to test the feasibility and acceptability as well as efficacy of the adapted intervention, CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) among women will illicit polysubstance use participating in a court-mandated jail-based 90-day substance use disorder treatment program. The main questions it aims to answer are:

1. What is the feasibility and acceptability of implementing the CHOICES-PLEAS intervention in a court-mandated jail-based substance use disorder treatment program? 2. Does participation in CHOICES-PLEAS lower the risk of a substance exposed pregnancy at 1 and 3 months after release compared to a control condition? 3. Does participation in CHOICES-PLEAS increase motivation to change substance use and reduce risky sexual behaviors at 1 and 3 months after release compared to a control condition? Participants will receive three one-on-one motivational interviewing sessions and one family planning referral visit during incarceration and one booster session at 1 month after release from jail.

Researchers will compare the CHOICES-PLEAS intervention to a control condition to see if participation in the intervention reduces risk of substance exposed pregnancy, increases motivation to change substance use, and reduces risk of risky sexual behaviors.

What is being tested

• CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) (behavioral)

Sponsor: St. Louis University · Participants: 90 · Started: Dec 4, 2023

Contact the study team

• Jennifer R Bello Kottenstette, MD · Phone: 314-617-3445
• Phebe Madhusudanan, MD, MPH · Phone: 314-977-7341

Official record on ClinicalTrials.gov — NCT05854836

Locations in the U.S.

Conditions

• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.