跳至主要内容
临床试验/NCT03673007
NCT03673007进行中(未招募)不适用

Michigan Contraceptive Access, Research, and Evaluation Study

University of Michigan18 个研究点 分布在 1 个国家目标入组 4,633 人开始时间: 2018年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,633
试验地点
18
主要终点
Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception)

研究概览

简要总结

M-CARES will use large-scale administrative data complemented by follow-up surveys and a randomized control trial (RCT) to estimate the causal impact of greater financial access to contraception on a comprehensive set of outcomes. Outcomes include contraceptive use, pregnancy, childbearing, and parenting strategies; partnership decisions and relationship quality; health and health care use; education, labor market success, and public assistance receipt; financial security; neighborhood quality; mental health and stress; and life plans. The resulting estimates will inform a more complete understanding of the costs and benefits of financial access to contraception and, therefore, the investment value of related policies and programs.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • M-CARES will recruit 5,000 women at Michigan Planned Parenthood of Michigan (PPMI) clinics who face potentially large out-of-pocket costs for highly effective contraceptives, especially LARC methods. In order to be eligible to participate in the study, the woman needs to meet the following criteria:
  • . 18-35 years old,
  • . physically capable (biologically female and fecund) and at risk of having a pregnancy (has sex with men),
  • . not pregnant at the time of enrollment and not wishing to become pregnant in the next 12 months,
  • . face some out-of-pocket costs for contraceptives at PPMI

排除标准

  • 未提供

研究组 & 干预措施

Treatment Group

Experimental

Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood

干预措施: Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) (Behavioral)

Treatment Group

Experimental

Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood

干预措施: Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) (Behavioral)

Control Group

No Intervention

Women in this arm of the study DO NOT receive a voucher for contraceptives. Women in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale.

结局指标

主要结局

Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception)

时间窗: 100 days from enrollment

Share of participants that purchase contraception as determined by Planned Parenthood of Michigan (PPMI) billing records and code the outcome based on purchases of contraceptives within 100 days of study enrollment (0 for no use of contraception; 1 for use of contraception).

Incidence of patients billing for long-run acting, reversible contraception (LARC) (0 no use of LARC/1 for use of LARC)

时间窗: Up to 1 year post enrollment

Share of participants that purchase long-run, acting reversible contraception as determined by PPMI billing records and code the outcome based on purchases of for long-run acting, reversible contraception (LARC) up to 1 year of enrollment (0 for no use of contraception; 1 for use of contraception)

Incidence of pregnancy up to 3 years post enrollment

时间窗: Up to 3 year post-enrollment

Incidence of pregnancies within 3 years of enrollment in the study. This data is obtained from PPMI records for pregnancy tests, emergency contraception, abortion, and childbirth as well as surveys.

Incidence of pregnancy up to 1 year post enrollment

时间窗: Up to 1 year post-enrollment

Incidence of pregnancies within one year of enrollment in the study. This data is obtained from PPMI records for pregnancy tests, emergency contraception, abortion, and childbirth as well as surveys.

Incidence of childbirth up to 3 year post enrollment

时间窗: Up to 3 years post enrollment

Incidence of childbirth up to 3 year after enrollment in the study. This data is obtained from PPMI records childbirth and prenatal care, state of Michigan records on natality, and surveys of participants.

Incidence of childbirth up to 1 year post enrollment

时间窗: Up to 1 years post enrollment

Incidence of childbirth up to 1 year after enrollment in the study. This data is obtained from PPMI records childbirth and prenatal care, state of Michigan records on natality, and surveys of participants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha Bailey

Adjunct Research Professor, Population Studies Center, Institute of Social Research

University of Michigan

研究点 (18)

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