Evaluation of an Intervention to Increase Post-abortion LARC Uptake.
Evaluation of an Intervention to Increase Post-abortion LARC Uptake: A Randomized Controlled Trial of Educational and Financial Counseling Prior to Clinical Presentation.
研究概览
详细说明
As repeat unintended pregnancy and abortion remain public health challenges, increasing long-acting reversible contraceptive (LARC), specifically intrauterine device (IUD) and contraceptive implant, use among women presenting for abortion care is a priority. Despite its efficacy and safety, LARC methods remain underutilized in the abortion setting.
This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30297
- Atlanta Women's Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women calling to schedule an appointment for an abortion and/or those who receive abortion services at the Atlanta Women's Center with fluency in English and able to provide informed consent
- 16 years and older
Exclusion Criteria:
-Younger than 16 years old
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Standart of Care
Standard of care at the clinic is to discuss the abortion procedure without specific contraceptive counseling given prior to the day of abortion procedure.
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实验性的:Contraceptive education prior to abortion
Addition (to the standard or care) of a brief phone contraceptive education with optional financial counseling referral prior to abortion visit.
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Contraceptive education script will be delivered over the phone prior to abortion visit.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods inserted immediately post abortion in the intervention and standard of care arms.
大体时间:Immidiately post abortion (day of the procedure).
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Proportion of LARC methods inserted immediately post abortion in the intervention and standard of care arms will be calculated based on data abstracted from patients' medical records.
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Immidiately post abortion (day of the procedure).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods used in the intervention and standard of care arms three months post abortion.
大体时间:Three months post abortion.
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This outcome is inclusive of immediate initiators and those who initiate by three months.
Proportion of LARC methods used in the intervention and standard of care arms will be calculated based on the 3-month follow-up phone interview.
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Three months post abortion.
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Cost-effectiveness analysis of the study intervention.
大体时间:Three months post abortion.
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The cost-effectiveness analysis will involve multiple parts.
The study team will initially complete a cost description of the interventions involving time spent in developing the scripts for LARC education and financial counseling, and additional time spent making contact with women and providing the augmented counseling compared to the initial pre-communication session.Incremental cost-effectiveness ratios for the intervention overall will be calculated compared to a 'base-case' of standard of care in the primary analysis.
This value will provide cost per additional women using LARC.
In a secondary analysis, the study team will compare differences between women receiving the educational component only versus 'base-case', and also women receiving the educational and financial counseling component versus 'base-case'.
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Three months post abortion.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB00094882
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Post Abortion Contraception的临床试验
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Kartos Therapeutics, Inc.招聘中原发性骨髓纤维化 (PMF) | 真性红细胞增多症后 MF (Post-PV-MF) | 原发性血小板增多症后 MF (Post-ET-MF)美国, 大韩民国, 德国, 澳大利亚, 匈牙利, 法国, 西班牙, 意大利, 台湾, 泰国, 巴西, 波兰, 火鸡, 以色列, 葡萄牙, 罗马尼亚, 阿根廷, 保加利亚, 加拿大, 克罗地亚, 捷克语, 立陶宛, 墨西哥, 菲律宾, 英国, 香港, 俄罗斯联邦, 希腊
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd完全的原发性骨髓纤维化 (PMF) | 真性红细胞增多症后骨髓纤维化(Post-PV MF) | 原发性血小板增多症后骨髓纤维化(Post-ET MF)中国