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

NCT ID: NCT02794597

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

Brief 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.

Detailed Description

This study aims to develop a reproductive health intervention to prevent 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 opioid medication-assisted treatment 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 long-acting reversible contraception. 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 opioid medication-assisted treatment 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.

For those randomized to the intervention arm, 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, the peer-educator will connect women to a Denver Health 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.

Conditions

Contraception

Keywords

Unplanned Pregnancy, long-acting reversible contraception (LARC), medications for opioid use disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Opioid Medication-Assisted Treatment only

Usual care - Opioid Medication Assisted Treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Peer led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE).

Group Type: EXPERIMENTAL

SHINE intervention group

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Biologically female
• 18-44 years of age
• receiving medications for opioid use disorder at one of two clinic sites
• not currently pregnant or trying to become pregnant and having no known medical reason that could prevent pregnancy
• having sex or intending to have sex with a biological male
• not currently using a LARC method.

Exclusion Criteria

• Being too intoxicated at the time of the interview or impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
• Have a known reason why they will not be available for the intervention or the follow-up interview.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Rinehart, PhD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

Denver Health and Hospital Authority

Denver, Colorado, United States

Countries

United States

References

Stowell MA, Thomas-Gale T, Jones HE, Binswanger I, Rinehart DJ. Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. Subst Abus. 2022;43(1):722-732. doi: 10.1080/08897077.2021.2007514.

Reference Type: DERIVED

PMID: 35100081 (View on PubMed)

Rinehart DJ, Stowell M, Collings A, Durfee MJ, Thomas-Gale T, Jones HE, Binswanger I. Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. J Subst Abuse Treat. 2021 Jul;126:108318. doi: 10.1016/j.jsat.2021.108318. Epub 2021 Feb 4.

Reference Type: DERIVED

PMID: 34116817 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R34DA039381-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-1236

Identifier Type: -

Identifier Source: org_study_id