Intervention for pregnant women in jail with substance use issues
A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women
This study is testing a new program for pregnant women in jail with substance use issues to see if it helps them reduce drug use and prevent substance-exposed pregnancies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | St. Louis University Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05854836 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility, acceptability, and efficacy of the CHOICES-PLEAS intervention among incarcerated women with substance use disorders. Participants will receive three motivational interviewing sessions and a family planning referral during their 90-day court-mandated treatment program. The study will assess whether this intervention reduces the risk of substance-exposed pregnancies and increases motivation to change substance use behaviors. A total of 90 women will be recruited and randomized into intervention and control groups over a 2.5-year period.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women capable of becoming pregnant who have a history of substance use and vaginal sex with male partners.
Not a fit: Patients who have undergone permanent sterilization or are using long-acting reversible contraceptives will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of substance-exposed pregnancies among incarcerated women.
How similar studies have performed: While similar interventions have been explored, this specific approach targeting incarcerated women with substance use disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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). * (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
Where this trial is running
St Louis, Missouri
- Buzz Westfall Justice Center — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer R Bello Kottenstette, MD — St. Louis University
- Study coordinator: Jennifer R Bello Kottenstette, MD
- Email: jennifer.bellokottenstette@health.slu.edu
- Phone: 314-617-3445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.