Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
时间窗: 3 and 6 months
Assess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.
次要结局
- Sexual Health Knowledge at Baseline by Intervention Condition.(Baseline)
- Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.(6 months)
- Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.(3 months)
- Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.(6 months)
- Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.(Baseline)
- Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.(baseline)
- Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.(6 months)
- Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.(3 months)
- Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.(3 months)