Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Condition: Contraception
Study type: Interventional

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.
    

Intervention name(s): SHINE intervention group
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Unplanned Pregnancy, long-acting reversible contraception (LARC), medications for opioid use disorder