Clinical trial NCT05854836: Preconception Intervention for Incarcerated Women With Substance Use
Official title: A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Keywords: Substance Use Disorders
Preconception Health
Motivational Interviewing
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.

Detailed description: The investigators will recruit 90 female participants from the court-mandated substance use disorder treatment program (CM-SUDTx) to participate in pilot testing of the intervention, CHOICES-PLEAS. Research staff will describe the study at an initial CM-SUDTx meeting 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.

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).

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 randomized to receive the intervention (n=45 women, 9 per cohort over 2.5 years) will participate in CHOICES-PLEAS. During participation in the 90-day CM-SUDTx, staff will administer the three motivational interviewing sessions one-on-one over an 8-week period, with one session every other week starting on week 4 of the CM-SUDTx. This will allow flexibility to schedule make-up sessions if needed as well as completion of the intervention in the second half of the CM-SUDTx, closer to release from jail. 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.

The 5 treatment cohorts randomized to the control group (n=45 women, 9 per cohort over 2.5 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, 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: one and three months after release from jail
Secondary outcomes:
measure: Self-efficacy to change substance use
timeFrame: one and three months after release from jail
measure: Self-efficacy to change risky sexual behavior
timeFrame: one and three months after release from jail
measure: Readiness to change substance use
timeFrame: one and three months after release from jail
measure: Readiness to change risky sexual behavior
timeFrame: one and three months after release from jail
measure: Decisional balance to change substance use
timeFrame: one and three months after release from jail
measure: Decisional balance to change contraception use
timeFrame: one and three months after release from jail
Other outcomes:
measure: Participant acceptance of and satisfaction with the intervention
timeFrame: 90 days
measure: Feasibility of delivering the intervention in the 90-day substance use disorder treatment program
timeFrame: 90 days
Locations:
city: Saint Louis
country: United States
facility: Buzz Westfall Justice Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jennifer R Bello Kottenstette, MD
role: PRINCIPAL_INVESTIGATOR
References: