Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine
NAS-MIET
Averting Neonatal Abstinence Syndrome Among Urban, Low-Income, Opioid-Using Young Women Receiving Medication-Assisted Treatment Using Buprenorphine
1 other identifier
interventional
80
1 country
1
Brief Summary
The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET). MIET will be delivered to women of childbearing age (18-44) through the Meharry Addiction Clinic to women residing in Nashville, Tennessee. There are two aims associated with this study. The primary aim is to determine the efficacy of MIET, to promote insertion of LARC among young, urban dwelling, low income women living with OUD and at-risk of unplanned pregnancy. The primary endpoint of this aim are: 1) meeting with a provider regarding initial assessment for LARC, 2) having a LARC implant. Because of potential contraindication for LARC insertion (i.e. obesity) the first endpoint of meeting with a LARC provider is most proximal to aim 1. However, determining the number of willing women that go on to receive the implant is also critical in that it reflects potential decreases in cost to the health care system through reduction of unintended pregnancy and related subsequent NAS in the newborn. The second aim for the study is to utilize qualitative and quantitative data collected for the study to modify the MIET intervention to more effectively meet the needs of the women in the study. Survey data for the study will be collected at baseline, one and six months. Of note, the baseline, one and six month survey data collections will provide potential co-variates to consider in analysis of aim one and two. The primary endpoints however will come from the six month records review. We will gain consent to access records at the baseline consent, and will gather these data from the Meharry Electronic Health Record.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedNovember 2, 2020
October 1, 2020
8 months
October 1, 2020
October 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LARC Consultation
Documentation in medical chart of patient accepting and attending a contraceptive consultation with a physician.
Medical charts will be examined and data extracted at six months post intervention
Secondary Outcomes (2)
Receiving a LARC implant/insertion
Medical charts will be examined and data extracted at six months post intervention
WHO Brief Quality of Life (QOL) Survey
The survey will be collected at baseline, one and six months.
Study Arms (2)
Information Only
ACTIVE COMPARATORWomen in both the control and treatment conditions will complete a baseline survey that includes the Mini-International Neuropsychiatric Interview (MINI),34 a contraceptive use survey,35 and the WHO Quality of Life-Brief (WHO-QOL-B).36 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.
Motivational Interviewing and Educational Training (MIET)
EXPERIMENTALWomen 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. The interventionist will receive respective patients' MINI for opioids,37 contraceptive survey, and WHO-QOL-B from the research coordinator, and the answers to the survey forms will expedite the conversation around each woman's contraceptive desires.
Interventions
Women in the intervention arm will receive a motivational interviewing intervention coupled with education on contraception and the potential for neonatal abstinence syndrome.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meharry Medical Collegelead
- Vanderbilt University Medical Centercollaborator
Study Sites (1)
Meharry Medical College
Nashville, Tennessee, 37208, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Cooper, PhD
Meharry Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be informed as to which group they are in. They will be randomized at the point of intake and assigned to one of two groups described above.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
November 2, 2020
Study Start
November 1, 2020
Primary Completion
July 1, 2021
Study Completion
October 31, 2021
Last Updated
November 2, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- All data will be available after October 31, 2021 when all collection and analysis are complete.
- Access Criteria
- Those wishing to access the data will have to contact the principal investigator, R. Lyle Cooper via email at rcooper@mmc.edu
Data Sharing. Interested researchers may request access to a deidentified data set of the data collected in this study. A data sharing agreement will be established between Meharry Medical College and the requesting researchers institution, and we will make every effort to ensure interested parties have access to our data.