Substance Use DisordersNCT05854836
Preconception Intervention for Incarcerated Women With Substance Use
A study testing CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) in people with Substance Use Disorders, run by St. Louis University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Buzz Westfall Justice Center
St Louis, Missouri, 63105
Brady Williams, 314-615-7239, bwilliams@stlouiscountymo.gov
Mia Sutton, (314) 615-5697, MSutton@stlouiscountymo.gov
About this study
Official title: A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women
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:
- What is the feasibility and acceptability of implementing the CHOICES-PLEAS intervention in a court-mandated jail-based substance use disorder treatment program?
- 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?
- 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.
Read the detailed description
The investigators will recruit 90 female participants from one of two jail-based SUD treatment programs: the court-mandated substance use disorder treatment program (CM-SUDTx) or the Medication for Addiction Treatment (MAT) Program to participate in pilot testing of the intervention, CHOICES-PLEAS. Research staff will describe the study at an initial CM-SUDTx meeting or with MAT program participants and invite interested women to meet with staff individually after their treatment session to be screened for eligibility. Over a 2.5-year period, there are ten 90-day CM-SUDTx cohorts, each with approximately 15 women (150 total). The investigators expect 130 women (13/cohort, 87%) to meet eligibility criteria. Of those eligible, the investigators expect about 9/cohort will enroll and complete the intervention based on pilot work indicating about 70% of CM-SUDTx participants are interested in research. Women in the MAT program have a diagnosis of OUD with or without additional substance use. The same inclusion criteria will be used to determine eligibility with the addition of participants needing to be confined between 2 and 6 months to allow time for study procedures to take place during incarceration.
The investigators will randomize the ten CM-SUDTx cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. The treatment cohorts will be divided into two cells by program start time within the study period (Year 2 quarter 2 through Year 4 quarter 3). The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45). Participants recruited from the MAT program will be randomized by individual.
All participants will complete a baseline survey before the intervention. The investigators will collect comprehensive participant contact information for all participants after participants complete a baseline survey. The 5 treatment cohorts and MAT program participants randomized to receive the intervention (n=45 women, 9 per cohort over 2.5 years) will participate in CHOICES-PLEAS. Research staff will administer the three motivational interviewing sessions one-on-one over an 8-week period. Referral and scheduling of a family planning appointment will take place in session 1 and the appointment may be scheduled at any time prior to completion of the CM-SUDTx or release from jail.
The 5 treatment cohorts and MAT program participants randomized to the control group (n=45 women, 9 per cohort over 2. years) will receive brief advice and referral consistent with other studies testing a similar intervention that includes general information about healthy lifestyle for women as well as a referral guide to local resources.
At completion of the CM-SUDTx or prior to release from jail, all participants will complete a survey. Women will be asked to review and update their contact information sheet and the one-month booster session and three-month assessment will be scheduled.
At 1-month post release, participants randomized in the intervention group will participate in a one-on-one motivational interviewing booster session at a convenient location. At 1- and 3-months post-release, all participants will complete an in-person assessment at a convenient location where they will complete a survey to measure continuation in treatment, provide a urine drug screen and pregnancy test, and reassess all measures collected at the time of release.
- Conditions
- Substance Use Disorders
- Being tested
- CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)
- Keywords
- Substance Use Disorders, Preconception Health, Motivational Interviewing
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHOICES-PLEAS | Experimental | 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. Receives: Behavioral: CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) |
| Control condition | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Defined as continued drug abstinence, absence of risky sexual behaviors, or both
Measured: one and three months after release from jail
Secondary outcomes (6)
Self-efficacy to change substance use
Self-efficacy will be assessed using the single item Abstinence Self-Efficacy scale with scores ranging from 1-10 with higher scores indicating higher confidence.
Measured: one and three months after release from jail
Self-efficacy to change risky sexual behavior
Self-efficacy will be assessed using the adapted 18-item Self-efficacy for Birth Control and Condom Use Scale with scores 18 - 90, with higher scores indicating higher confidence.
Measured: one and three months after release from jail
Readiness to change substance use
Readiness to change will be assessed using the adapted 12-item Readiness to Change Questionnaire for substance use with scores from 12 to 60 with higher scores indicating higher levels of readiness.
Measured: one and three months after release from jail
Readiness to change risky sexual behavior
Readiness to change will be assessed using the adapted 11-item Readiness to Change Questionnaire for risky sexual behaviors with scores from 11 to 55 with higher scores indicating higher levels of readiness
Measured: one and three months after release from jail
Decisional balance to change substance use
Decisional balance will be assessed using the 20-item Decisional Balance Scale for substance use. Each question asking about importance of making a decision is rated from 1 to 5, with 5 being extremely important and 1 being not important at all. A difference score is calculated by subtracting scores of the cons of substance use from the pros of substance use. Positive numbers indicate endorsing more pros than cons for substance use.
Measured: one and three months after release from jail
Decisional balance to change contraception use
Decisional balance will be assessed using the 20-item Decisional Balance Scale for contraception use. Each question asking about importance of making a decision is rated from 1 to 5, with 5 being extremely important and 1 being not important at all. A difference score is calculated by subtracting scores of the cons of using contraception from the pros of using contraception. Positive numbers indicate endorsing more pros than cons for using contraception.
Measured: one and three months after release from jail
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start4 Dec 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize the ten 90-day court-mandated substance use disorder treatment cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. Ninety-day cohorts run sequentially. The treatment cohorts will be divided into two cells by program start time within the study period. The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Bello-Kottenstette, MD MS, St. Louis University
- Investigators
- Jennifer R Bello Kottenstette, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854836
- Sponsor's protocol ID
- 33381
- Other IDs
- K23DA053433
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan is still in development.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women
- ClinicalTrials.gov ID
- NCT05854836
- Acronym / sponsor ID
- 33381
- Conditions
- Substance Use Disorders
- Keywords
- Substance Use Disorders, Preconception Health, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the feasibility and acceptability of implementing the CHOICES-PLEAS intervention in a court-mandated jail-based substance use disorder treatment program?
- 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?
- 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.
Detailed description
The investigators will recruit 90 female participants from one of two jail-based SUD treatment programs: the court-mandated substance use disorder treatment program (CM-SUDTx) or the Medication for Addiction Treatment (MAT) Program to participate in pilot testing of the intervention, CHOICES-PLEAS. Research staff will describe the study at an initial CM-SUDTx meeting or with MAT program participants and invite interested women to meet with staff individually after their treatment session to be screened for eligibility. Over a 2.5-year period, there are ten 90-day CM-SUDTx cohorts, each with approximately 15 women (150 total). The investigators expect 130 women (13/cohort, 87%) to meet eligibility criteria. Of those eligible, the investigators expect about 9/cohort will enroll and complete the intervention based on pilot work indicating about 70% of CM-SUDTx participants are interested in research. Women in the MAT program have a diagnosis of OUD with or without additional substance use. The same inclusion criteria will be used to determine eligibility with the addition of participants needing to be confined between 2 and 6 months to allow time for study procedures to take place during incarceration.
The investigators will randomize the ten CM-SUDTx cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. The treatment cohorts will be divided into two cells by program start time within the study period (Year 2 quarter 2 through Year 4 quarter 3). The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45). Participants recruited from the MAT program will be randomized by individual.
All participants will complete a baseline survey before the intervention. The investigators will collect comprehensive participant contact information for all participants after participants complete a baseline survey. The 5 treatment cohorts and MAT program participants randomized to receive the intervention (n=45 women, 9 per cohort over 2.5 years) will participate in CHOICES-PLEAS. Research staff will administer the three motivational interviewing sessions one-on-one over an 8-week period. Referral and scheduling of a family planning appointment will take place in session 1 and the appointment may be scheduled at any time prior to completion of the CM-SUDTx or release from jail.
The 5 treatment cohorts and MAT program participants randomized to the control group (n=45 women, 9 per cohort over 2. years) will receive brief advice and referral consistent with other studies testing a similar intervention that includes general information about healthy lifestyle for women as well as a referral guide to local resources.
At completion of the CM-SUDTx or prior to release from jail, all participants will complete a survey. Women will be asked to review and update their contact information sheet and the one-month booster session and three-month assessment will be scheduled.
At 1-month post release, participants randomized in the intervention group will participate in a one-on-one motivational interviewing booster session at a convenient location. At 1- and 3-months post-release, all participants will complete an in-person assessment at a convenient location where they will complete a survey to measure continuation in treatment, provide a urine drug screen and pregnancy test, and reassess all measures collected at the time of release.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will randomize the ten 90-day court-mandated substance use disorder treatment cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. Ninety-day cohorts run sequentially. The treatment cohorts will be divided into two cells by program start time within the study period. The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45).
| Arm | Type | Receives |
|---|---|---|
| CHOICES-PLEAS | Experimental | Behavioral: CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)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. |
| Control condition | No intervention | –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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CHOICES-PLEAS |
Primary outcome
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
Defined as continued drug abstinence, absence of risky sexual behaviors, or both
6 secondary outcomes
Self-efficacy to change substance use
Time frame: one and three months after release from jail
Self-efficacy to change risky sexual behavior
Time frame: one and three months after release from jail
Readiness to change substance use
Time frame: one and three months after release from jail
Readiness to change risky sexual behavior
Time frame: one and three months after release from jail
Decisional balance to change substance use
Time frame: one and three months after release from jail
Decisional balance to change contraception use
Time frame: one and three months after release from jail
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan is still in development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer R Bello Kottenstette, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) in people with Substance Use Disorders, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer R Bello Kottenstette, MD (314-617-3445, jennifer.bellokottenstette@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.