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Preconception Intervention for Incarcerated Women With Substance Use
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 Start (Actual) 4 December 2023
🗓️ Primary Completion (Estimated) June 2026
✅ Study Completion (Estimated) July 2027
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    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).

    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
Ages Eligible for Study: 18 Years to 44 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 April 2023
  • First Submitted that Met QC Criteria 8 May 2023
  • First Posted 11 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 December 2023
  • Last Update Posted 6 December 2023
  • Last Verified December 2023
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