Averting Neonatal Abstinence Syndrome Among Urban, Low-Income, Opioid-Using Young Women Receiving Medication-Assisted Treatment Using Buprenorphine

This is an efficacy trial of the Motivational Interviewing (MI) and Educational Training (MIET) program. The approach includes LARC education and brief MI to encourage LARC adoption.

A randomized trial design with pre- and post-assessments will be used to meet study aims.

Women in both the control and treatment conditions will complete a baseline survey that includes the Mini-International Neuropsychiatric Interview (MINI), a contraceptive use survey, and the WHO Quality of Life-Brief (WHO-QOL-B). Women in the control group will be provided a color brochure with easy-to-read information about the advantages of LARC. Via this brochure, control group women will be provided no-cost options and corresponding referral information for receiving LARC. Women randomized to the treatment group will complete the baseline survey and receive the same brochure; however, they also will receive structured education regarding unintended pregnancies among women using opioids, potential complications associated with opioid, alcohol, and other drug use, and education on contraceptive use (with an emphasis on LARC). This structured education will be coupled with a brief, initial MI conversation.

Consistent with the peak years for having unplanned pregnancies, we will recruit women 18-44 years of age, who are reproductively capable (intact uterus, not sterilized), who are classified with opioid use disorder (OUD) based on a >3 MINI score, and who indicate having male sex partner(s). Women will be excluded if they: (1) are knowingly pregnant; (2) are identified as pregnant from an administered pregnancy test; (3) express a current intent to conceive; (4) are currently using Depo-Provera to avert pregnancy; or (5) already have LARC insertion. Recruitment and intervention will occur sequentially and will be delivered in the office-based opioid treatment (OBOT) clinic.

All patients meeting the inclusion criteria will be approached for recruitment during the fifth week of their induction into MAT. The research coordinator will recruit patients, gathering informed consent and baseline data, as well as randomizing patients to the control or treatment conditions. She will electronically forward screens to the treatment group interventionist to expedite the intervention by providing data on opioid use, pregnancy risk, and participant quality of life. The control group interventionist will know only that the patient is eligible for LARC and will not receive the baseline data. The research coordinator will collect all survey data at baseline and up to five days before, or seven days after, the one- and six-month follow-up time points. The consent form will request permission to acquire Electronic Health Record (EHR) data from the clinic for a one- and six-month extraction to determine whether the women experienced unplanned pregnancies, had contraceptive consultations, and received LARC implant/insertion.