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

NCT02794597 | Completed Results

• 2 other identifiers: 15-12361R34DA039381-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.

  Assess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.

  3 and 6 months

Secondary Outcomes (9)

• Sexual Health Knowledge at Baseline by Intervention Condition.

  Baseline

• Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.

  3 months

• Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.

  6 months

• Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.

  Baseline

• Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.

  3 months

Study Arms (2)

Opioid Medication-Assisted Treatment only

NO INTERVENTION

Usual care - Opioid Medication Assisted Treatment

Intervention

EXPERIMENTAL

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

Behavioral: SHINE intervention group

Interventions

SHINE intervention group 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).

Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biologically female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Publications (2)

• 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.

  PMID: 35100081 DERIVED

• 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.

  PMID: 34116817 DERIVED

Limitations and Caveats

Larger sample size needed to detect significant differences in long-acting reversible contraceptive use. The primary study site and where we referred participants for family planning services provides access to low-cost sexual health education and contraception, which may not exist elsewhere.

Results Point of Contact

• Title: Deborah Rinehart
• Organization: Denver Health & Hospital Authority

deborah.rinehart@dhha.org

303-602-2743

Study Officials

• Deborah Rinehart, PhD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)