Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 3/31/2019 |
| Start Date: | August 2016 |
| End Date: | July 2019 |
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.
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.
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.
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.
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.
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