Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
NCT05854836

Preconception Intervention for Incarcerated Women With Substance Use

Led by St. Louis University · Updated on 2025-07-22

90

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

S

St. Louis University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Preconception Intervention for Incarcerated Women With Substance Use

Who Can Participate

Age: 18Years - 49Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • Capable of becoming pregnant (not permanently sterilized and not using a highly effective long-acting reversible birth control method such as intrauterine device or implant)
  • Engaged in vaginal sex with a male partner during the three years 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) in the three months prior to arrest or entering the treatment program
  • For women recruited from the MAT Program: expected length of incarceration at the St. Louis County Jail is 2 to 6 months with expected release into the community
Not Eligible

You will not qualify if you...

  • Participated in a focus group that helped create the intervention adaptation
  • Non-English-speaking
  • Not capable of becoming pregnant (permanently sterilized or using a long-acting reversible contraceptive method)
  • No vaginal sex with a male partner in the three years prior to incarceration or entering the treatment program
  • No use of an illicit substance or only alcohol or marijuana use not combined with another substance

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Trial Site Locations

Total: 1 location

1

Buzz Westfall Justice Center

St Louis, Missouri, United States, 63105

Actively Recruiting

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Research Team

J

Jennifer R Bello Kottenstette, MD

CONTACT

P

Phebe Madhusudanan, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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