Last updated on April 2019

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


Brief description of study

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 HBM 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.

Detailed Study Description

This study aims to develop a reproductive health intervention to support dual protection against STI/HIV and unintended pregnancy for women of child-bearing age in opioid medication-assisted treatment (OMAT). It will be conducted in two phases. The first formative phase will employ individual interviews and focus groups with women between the ages of 18 and 44 and in OMAT to better understand: pregnancy desires/motivation and perceived susceptibility and severity, contraceptive knowledge, perceived benefits/barriers, self-efficacy, social norms, behaviors, and access to contraception and family planning services, especially related to LARCs. This information, coupled with prior evidence and theory, will be used to develop a brief peer-led behavioral intervention.

In the second phase, we will conduct a randomized controlled trial to assess the acceptability, feasibility and the initial efficacy of the developed intervention. Women will be recruited from two OMAT facilities and once they have consented and the baseline survey is completed they will be randomized to either the behavioral intervention or usual care. Participants will complete a baseline, three and six-month post-baseline follow up survey. At the end of each interview or focus group, participants will receive an educational sexual health pamphlet.

The first session will occur immediately post-consent and baseline, and the second will occur 2-4 weeks post-baseline. A trained peer-educator will deliver the behavioral intervention that will provide accurate, unbiased information about Long Acting Reversible Contraception (intrauterine devices and subdermal implants) and all other contraceptive methods (including effectiveness, advantages, and disadvantages), help women assess their needs (pregnancy desires compared to behavior), and utilize motivational interviewing to empower them to make an informed decision regarding their sexual health. For those that are interested in birth control, the peer-educator will also connect women to a DH Community Health Clinic or a clinic of their choosing to further explore appropriate birth control methods. The medical clinic will assess the woman and determine and dispense the most appropriate method.

Clinical Study Identifier: NCT02794597

Contact Investigators or Research Sites near you

Start Over

Denver Health and Hospital Authority

Denver, CO United States

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.