Preconception Intervention for Incarcerated Women With Substance Use (NCT05854836) | Clinical Trial Compass
RecruitingNot Applicable
Preconception Intervention for Incarcerated Women With Substance Use
United States90 participantsStarted 2023-12-04
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: one and three months after release from jail