Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794597
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Denver Health and Hospital Authority

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 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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: Intervention Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Study Start Date : August 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
No Intervention: Opioid Medication-Assisted Treatment
Usual care - Opioid Medication Assisted Treatment
Experimental: Intervention
Peer led, behavioral sexual health intervention
Behavioral: Intervention
a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.




Primary Outcome Measures :
  1. Develop a sustainable behavioral patient-centered peer-led sexual health intervention [ Time Frame: Months 2-8 ]
    Development of a sustainable behavioral patient centered peer-led sexual health intervention that can be delivered within the context of treatment. Qualitative methods (focus groups and interviews) will be used, as well as existing literature.

  2. Assess the feasibility and efficacy of the intervention [ Time Frame: 9-36 ]
    Assess the intervention acceptability, feasibility and initial efficacy (family planning/clinical visits, sexual risk behavior and up take of birth control specifically long-acting reversible contraceptives (LARC)), using baseline/follow up surveys and review of medical records at 6 months.


Secondary Outcome Measures :
  1. Explore the relationship of Health Belief Model and LARC uptake [ Time Frame: Months 9-36 ]
    Exploratory relationship between Health Belief Model constructs and LARC uptake using baseline/follow up surveys designed around this model, and review of medical records at 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Biologically female
  • 18-44 years of ages
  • being in opioid medication-assisted treatment 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794597


Locations
Layout table for location information
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Deborah Rinehart, PhD Denver Health and Hospital Authority
Layout table for additonal information
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02794597    
Other Study ID Numbers: 15-1236
1R34DA039381-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Denver Health and Hospital Authority:
Unplanned Pregnancy, LARC