Recruiting

Observational Study

Sponsor:

St. Louis University

Code:

NCT05854836

Conditions

Substance Use Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Substance Use Disorders

Study ID

NCT05854836

Start date

Dec 4, 2023

Status verified date

Jul, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CHOICES-PLEAS

Participants in the experimental arm will receive the motivational interviewing intervention, CHOICES-PLEAS which consists of three one-on-one sessions and one family planning referral visit during incarceration and one booster session at one month after release from jail.

no intervention: Control condition

Participants in the active comparator will receive a control condition that consists of a booklet with general information about healthy lifestyle for women as well as a referral guide to local resources.

Interventions

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

CHOICES-PLEAS includes four manual-guided motivational interviewing sessions delivered by a trained counselor and one family planning counseling session delivered by a family planning clinician. The intervention is based on the Transtheoretical Model (TTM) of behavior change and motivational interviewing that includes a decisional balance exercise, goal self-selection, self-monitoring, self-generated plans, and importance and confidence scales. By using a patient-centered approach based on the TTM that meets patients where they are, counselors can have a more effective impact on patient behaviors. This adaptation from the original CHOICES intervention contains unique features focused on the incarcerated setting, illicit polysubstance use, and risky sexual behaviors most common among women with illicit polysubstance use.

Primary outcome measure

  • 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 [ Time Frame: one and three months after release from jail ]

Central Contacts and Locations

Central contacts

Jennifer R Bello Kottenstette, MD

314-617-3445jennifer.bellokottenstette@health.slu.edu

Phebe Madhusudanan, MD, MPH

314-977-7341phebe.madhusudanan@health.slu.edu

Locations

Buzz Westfall Justice Center

Recruiting

St Louis, Missouri, United States, 63105

Contacts

Brady Williams

314-615-7239bwilliams@stlouiscountymo.gov

Mia Sutton

(314) 615-5697MSutton@stlouiscountymo.gov

More Information

Sponsor

St. Louis University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Substance Use Disorders
  • Preconception Health
  • Motivational Interviewing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis University on 2026-07-23.