Clinical trial NCT02794597: Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Official title: Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Unplanned Pregnancy, long-acting reversible contraception (LARC), medications for opioid use disorder
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-06-09
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Sexual Health Knowledge at Baseline by Intervention Condition.
timeFrame: Baseline
measure: Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.
timeFrame: 3 months
measure: Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.
timeFrame: 6 months
measure: Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.
timeFrame: Baseline
measure: Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.
timeFrame: 3 months
measure: Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.
timeFrame: 6 months
measure: Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.
timeFrame: baseline
measure: Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.
timeFrame: 3 months
measure: Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Deborah Rinehart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.