Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
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|ClinicalTrials.gov Identifier: NCT02794597|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Behavioral: Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Opioid Medication-Assisted Treatment
Usual care - Opioid Medication Assisted Treatment
Peer led, behavioral sexual health intervention
a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
- 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.
- 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.
- 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.
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
|United States, Colorado|
|Denver Health and Hospital Authority|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Deborah Rinehart, PhD||Denver Health and Hospital Authority|