Improving Effective Contraceptive use Among Opioid-Maintained Women: Stage II

描述(由申请人提供)：在阿片类药物依赖的妇女中，几乎每10次怀孕中就有9次是计划外的。意外怀孕给母亲和孩子带来了许多代价高昂的不良后果；仅新生儿禁欲综合症(NAS)一项的治疗费用每年就超过7亿美元。尽管这些数字令人沮丧，但我们知道没有有效的干预措施来减少阿片类药物或其他非法药物使用者的意外怀孕。我们开发了一种干预措施，并正在进行试点测试，以增加阿片类药物维持(OM)妇女在其OM治疗诊所提供的处方避孕药的使用量。许多OM治疗诊所的常规护理包括提供有关避孕方法的信息，并将患者转介给社区的计划生育提供者。拟议的干预措施增加了(1)世界卫生组织(WHO)的避孕议定书和(2)对参加礼宾访问的经济奖励。在第一次干预访问中，OM妇女在选择处方避孕方法方面得到帮助，提供关于她们喜欢的方法的有组织的教育咨询和免费供应，并提供立即开始的选择。在随后的干预访问中，他们得到了管理副作用和解决遵从性问题的支持，免费补充他们选择的避孕方法，并在指示时提供转换方法的帮助。他们还获得经济奖励，这取决于他们出席这些定期访问的每一次。我们正在进行的IB阶段试点试验数据有力地支持了这种干预的可行性和初步效果，在为期6个月的干预结束时，使用处方避孕药的OM妇女被分配到试验性干预中的人数是对照条件下妇女的5倍。在这些有希望的试验数据的基础上，本申请提出了一项完全随机对照的第二阶段试验，以严格评估这种创新干预的疗效和成本效益。有意外怀孕风险的妇女(N=195)将被随机分配到三种研究条件之一：(1)常规护理；(2)常规护理+世卫组织避孕方案；或(3)常规护理世卫组织避孕方案+经济奖励。所有参与者的避孕药使用情况将在试验后1、3、6和12个月的后续评估中进行评估。这一设计将使我们能够更全面地评估 干预的效果，同时也使我们能够隔离世卫组织的贡献和财政奖励部分，这两个部分都是第二阶段干预发展的关键目标。将通过评估预防和避免生育的每一次额外的阿片类药物暴露怀孕的增量成本来评估成本效益。这项拟议的研究有可能建立第一个有效和具有成本效益的干预措施，以增加非法药物使用者使用处方避孕药具。这项研究还可能对避孕决策产生重要的新见解，这将有助于为其他有意外怀孕风险的妇女群体制定更有效的干预措施。

DESCRIPTION (provided by applicant): Nearly 9 of every 10 pregnancies among opioid-dependent women is unplanned. Unintended pregnancy results in many costly adverse consequences for both mother and child; treatment of neonatal abstinence syndrome (NAS) alone costs more than $700 million annually. Despite these dismal figures, we know of no efficacious interventions for decreasing unintended pregnancy among opioid or other illicit drug users. We developed and are pilot-testing an intervention to increase prescription contraceptive use by opioid- maintained (OM) women that is delivered in their OM treatment clinic. Usual care in many OM treatment clinics involves giving out information about contraceptive methods and referring patients to family planning providers in the community. The proposed intervention adds (1) the World Health Organization's (WHO) contraception protocol and (2) financial incentives for attendance at protocol visits. At the first intervention visit, OM women receive assistance with choosing a prescription contraceptive method, are provided structured educational counseling about and a free supply of their preferred method, and are offered the option of initiating it immediately. At subsequent intervention visits, they receive support to manage side effects and problem-solve compliance problems, free refills of their chosen contraceptive method, and assistance with switching methods when indicated. They also earn financial incentives contingent on their attendance at each of these regularly scheduled visits. Our ongoing Stage IB pilot trial data strongly support the feasibility and initial efficacy of this intervention, with 5-times more OM women assigned to the experimental intervention using prescription contraceptives at the end of the 6-month intervention compared to control condition women. Building on these promising pilot data, the present application proposes a fully randomized controlled Stage II trial to rigorously evaluate the efficacy and cost-effectiveness of this innovative intervention. OM women at risk for unintended pregnancy (N=195) will be randomly assigned to one of three study conditions: (1) usual care; (2) usual care + WHO contraception protocol; or (3) usual care WHO contraception protocol + financial incentives for attendance. Contraceptive use by all participants will be evaluated at follow-up assessments scheduled 1, 3, 6, and 12 months after trial intake. This design will allow us to more fully assess the efficacy of the intervention while also allowing us to isolate the contribution of the WHO and financial incentives components, both key objectives of Stage II intervention development. Cost-effectiveness will be evaluated by assessing the incremental costs of each additional opioid-exposed pregnancy prevented and birth avoided. The proposed research has the potential to establish the first efficacious and cost-effective intervention for increasing prescription contraceptive use in illicit drug users. The research may also produce important new insights into contraceptive decision-making that will aid in the development of more efficacious interventions for other populations of women at risk for unintended pregnancy.