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

基本信息

  • 批准号:
    8759161
  • 负责人:
  • 金额:
    $ 60.44万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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):阿片类药物依赖妇女中每10次怀孕中有近9次是计划外的。意外怀孕会给母亲和孩子带来许多代价高昂的不良后果;仅治疗新生儿禁欲综合征(NAS)一项每年就花费7亿多美元。尽管有这些令人沮丧的数字,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,并正在进行中试测试,以增加阿片类药物维持(OM)妇女在OM治疗诊所提供的处方避孕药的使用。许多OM治疗诊所的生殖保健包括提供有关避孕方法的信息,并将患者介绍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)的避孕协议和(2)对参加协议访问的经济奖励。在第一次干预访问时,OM妇女在选择处方避孕方法方面得到帮助,得到关于其首选方法的结构化教育咨询和免费供应,并提供立即开始使用的选择。在随后的干预访问中,他们得到支持,以管理副作用和解决问题的依从性问题,免费补充他们选择的避孕方法,并在必要时协助转换方法。他们还根据每次定期访问的出席情况获得经济奖励。我们正在进行的IB阶段试点试验数据强烈支持这种干预措施的可行性和初步疗效,在6个月干预结束时,分配到实验性干预措施的使用处方避孕药的OM女性是对照组女性的5倍。基于这些有希望的试点数据,本申请提出了完全随机化的对照II期试验,以严格评估这种创新干预的功效和成本效益。将有意外妊娠风险的OM女性(N=195)随机分配至三种研究条件之一:(1)常规护理;(2)常规护理+ WHO避孕方案;或(3)常规护理WHO避孕方案+就诊的经济奖励。将在试验开始后1、3、6和12个月的随访评估中评价所有受试者的避孕措施使用情况。这种设计将使我们能够更全面地评估 这将使我们能够区分世卫组织的贡献和财政激励因素,这两个因素都是第二阶段干预措施开发的关键目标。将通过评估每增加一次预防阿片类药物暴露妊娠和避免分娩的增量成本来评价成本效益。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的处方避孕药使用。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制定更有效的干预措施。

项目成果

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Sarah H Heil其他文献

Sarah H Heil的其他文献

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{{ truncateString('Sarah H Heil', 18)}}的其他基金

Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes
治疗患有阿片类药物使用障碍的孕妇的医学监督戒断与激动剂维持治疗:孕产妇、胎儿和新生儿结局
  • 批准号:
    9903275
  • 财政年份:
    2018
  • 资助金额:
    $ 60.44万
  • 项目类别:
Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes
治疗患有阿片类药物使用障碍的孕妇的医学监督戒断与激动剂维持治疗:孕产妇、胎儿和新生儿结局
  • 批准号:
    10375543
  • 财政年份:
    2018
  • 资助金额:
    $ 60.44万
  • 项目类别:
Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant Women
弱势人群中的低尼古丁含量香烟:孕妇
  • 批准号:
    10477410
  • 财政年份:
    2013
  • 资助金额:
    $ 60.44万
  • 项目类别:
Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant Women
弱势人群中的低尼古丁含量香烟:孕妇
  • 批准号:
    10247030
  • 财政年份:
    2013
  • 资助金额:
    $ 60.44万
  • 项目类别:
Testing the Reliability and Validity of Pupil Diameter in Opioid-exposed neonates
测试阿片类药物暴露新生儿瞳孔直径的可靠性和有效性
  • 批准号:
    8293516
  • 财政年份:
    2012
  • 资助金额:
    $ 60.44万
  • 项目类别:
Testing the Reliability and Validity of Pupil Diameter in Opioid-exposed neonates
测试阿片类药物暴露新生儿瞳孔直径的可靠性和有效性
  • 批准号:
    8699737
  • 财政年份:
    2012
  • 资助金额:
    $ 60.44万
  • 项目类别:
Testing the Reliability and Validity of Pupil Diameter in Opioid-exposed neonates
测试阿片类药物暴露新生儿瞳孔直径的可靠性和有效性
  • 批准号:
    8545754
  • 财政年份:
    2012
  • 资助金额:
    $ 60.44万
  • 项目类别:
Improving effective contraceptive use among opioid-maintained women
改善使用阿片类药物的女性的有效避孕方法
  • 批准号:
    8309018
  • 财政年份:
    2011
  • 资助金额:
    $ 60.44万
  • 项目类别:
Improving effective contraceptive use among opioid-maintained women
改善使用阿片类药物的女性的有效避孕方法
  • 批准号:
    8190800
  • 财政年份:
    2011
  • 资助金额:
    $ 60.44万
  • 项目类别:
CLINICAL TRIAL: MOTHER
临床试验:母亲
  • 批准号:
    7952101
  • 财政年份:
    2009
  • 资助金额:
    $ 60.44万
  • 项目类别:

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