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Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)

NCT02794597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2020-11-16

Study results available
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Summary

Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.

Conditions

  • Contraception

Interventions

BEHAVIORAL

SHINE intervention group

Includes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE).

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Deborah Rinehart, PhD · Denver Health and Hospital Authority

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794597 on ClinicalTrials.gov