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

Not Applicable

Active, not recruiting

• Conditions: Pregnancy
• Interventions: 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)

• Registration Number: NCT03673007
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-15
• Study Start: 2018-08-26
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 4633

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:

1. . 18-35 years old,
2. . physically capable (biologically female and fecund) and at risk of having a pregnancy (has sex with men),
3. . not pregnant at the time of enrollment and not wishing to become pregnant in the next 12 months,
4. . face some out-of-pocket costs for contraceptives at PPMI

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)	Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood
Treatment Group	Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)	Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood

Primary Outcome Measures

Name	Time	Method
Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception)	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)	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	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	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 1 year post enrollment	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.
Incidence of childbirth up to 3 year post enrollment	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.

Trial Locations

Locations (9)

Planned Parenthood - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

Planned Parenthood - Ferndale; 🇺🇸 Ferndale, Michigan, United States

Planned Parenthood - Livonia; 🇺🇸 Livonia, Michigan, United States

Planned Parenthood - Detroit; 🇺🇸 Detroit, Michigan, United States

Planned Parenthood - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

Planned Parenthood - Lansing; 🇺🇸 Lansing, Michigan, United States

Planned Parenthood - Traverse City; 🇺🇸 Traverse City, Michigan, United States

Planned Parenthood - Warren; 🇺🇸 Warren, Michigan, United States

Planned Parenthood - Ann Arbor-West; 🇺🇸 Ann Arbor, Michigan, United States