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

改善使用阿片类药物的女性的有效避孕方法：第二阶段

• 批准号: 8759161
• 负责人: Sarah H Heil
• 金额: $ 60.44万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759161
• 关键词: Address; Adherence; Adverse effects; Attitude; Behavioral; Belief; Binding; Biochemical; Biochemical Markers; Biological Markers; Birth; Characteristics; Child; Clinic; Clinical Trials; Communities; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Counseling; Data; Decision Making; Development; Disadvantaged; Drug user; Economics; Effectiveness of Interventions; Employee Strikes; Family Planning; Future; General Population; Globulins; Goals; Grant; Health behavior; Hormones; Illicit Drugs; Implant; Impulsivity; Incentives; Injection of therapeutic agent; Intake; Intervention; Intrauterine Devices; Knowledge; Measures; Methods; Mothers; Neonatal Abstinence Syndrome; Opioid; Oral Contraceptives; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Population; Predisposition; Pregnancy; Prevalence; Problem Solving; Protocols documentation; Provider; Public Health; Questionnaires; Randomized; Reporting; Research; Risk; Schedule; Sexually Transmitted Diseases; Staging; Steroids; Structure; Surveys; Testing; Time; Treatment Efficacy; Unplanned pregnancy; Visit; Vulnerable Populations; Woman; World Health Organization; adverse outcome; condoms; cost; cost effective; cost effectiveness; design; discounting; effective intervention; financial incentive; follow-up; high risk; improved; innovation; insight; novel; pill; pilot trial; pregnant; prevent; primary outcome; programs; public health relevance; sex; statistics; therapy development; transmission process; treatment as usual; unintended pregnancy

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.

描述（由申请人提供）：阿片类药物依赖女性中，每 10 例中有近 9 例是计划外怀孕。意外怀孕会给母亲和孩子带来许多代价高昂的不良后果；仅新生儿戒断综合症 (NAS) 的治疗费用每年就超过 7 亿美元。尽管数字令人沮丧，但我们知道没有有效的干预措施可以减少阿片类药物或其他非法药物使用者的意外怀孕。我们开发并正在试点测试一种干预措施，以增加阿片类药物维持 (OM) 女性处方避孕药的使用，该干预措施在 OM 治疗诊所提供。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服务提供者。拟议的干预措施增加了 (1) 世界卫生组织 (WHO) 的避孕方案和 (2) 对参加方案访问的经济激励。在第一次干预访问时，OM 妇女会获得选择处方避孕方法的帮助，获得有关其首选方法的结构化教育咨询和免费提供，并可以选择立即启动。在随后的干预访问中，他们会获得管理副作用和解决依从性问题的支持，免费补充他们选择的避孕方法，并在有需要时帮助更换方法。他们还可以根据每次定期访问的参加情况获得经济奖励。我们正在进行的 IB 期试点试验数据有力地支持了这种干预措施的可行性和初步疗效，与对照组女性相比，在 6 个月干预结束时分配到使用处方避孕药进行实验干预的 OM 女性人数是对照组女性的 5 倍。基于这些有希望的试点数据，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措施的功效和成本效益。有意外怀孕风险的 OM 女性 (N=195) 将被随机分配到以下三种研究条件之一：(1) 常规护理； (2)常规护理+WHO避孕方案； (3) 常规护理世卫组织避孕方案 + 参加的经济奖励。所有参与者的避孕措施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。这种设计将使我们能够更全面地评估 干预措施的有效性，同时也使我们能够区分世界卫生组织的贡献和财政激励部分，这都是第二阶段干预措施发展的关键目标。将通过评估每一次预防和避免阿片类药物暴露妊娠和避免分娩的增量成本来评估成本效益。拟议的研究有可能建立第一个有效且具有成本效益的干预措施，以增加非法药物使用者处方避孕药的使用。该研究还可能为避孕决策提供重要的新见解，有助于为其他有意外怀孕风险的女性群体制定更有效的干预措施。