Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1

Study Overview
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Brief Summary
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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.

Official Title
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Michigan Contraceptive Access, Research, and Evaluation Study

Conditions
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Pregnancy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood | Behavioral: Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)<br>* M-CARES will randomize allocation of vouchers (gift cards) for contraception valued up to 50% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred between August 18, 2018, and March 3, 2019.<br>Behavioral: Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)<br>* M-CARES will randomize allocation of vouchers (gift cards) for contraception valued up to 100% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred after March 3, 2019.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception) | 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). | 100 days from enrollment | 
| Incidence of patients billing for long-run acting, reversible contraception (LARC) (0 no use of LARC/1 for use of LARC) | 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) within 100 days of enrollment (0 for no use of contraception; 1 for use of contraception) | 100 days from enrollment | 
| Incidence of patients billing for long-run acting, reversible contraception (LARC) (0 no use of LARC/1 for use of LARC) | 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) | Up to 1 year post enrollment | 
| Incidence of pregnancy 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. | Up to 1 year post-enrollment | 
| Incidence of pregnancy up to 3 years 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. | Up to 3 year post-enrollment | 
| Incidence of childbirth up to 1 year 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. | Up to 1 years post enrollment | 
| Incidence of childbirth up to 3 year 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. | Up to 3 years post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception, financial access to reproductive health care, unintended pregnancy