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

Michigan Contraceptive Access, Research, and Evaluation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03673007
Acronym
M-CARES
Enrollment
4633
Registered
2018-09-17
Start date
2018-08-26
Completion date
2028-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

contraception, financial access to reproductive health care, unintended pregnancy

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.

Interventions

BEHAVIORALGift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)

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.

BEHAVIORALGift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)

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.

Sponsors

University of Michigan
Lead SponsorOTHER
National Opinion Research Center
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception)100 days from enrollmentShare 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)100 days from enrollmentShare 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)
Incidence of pregnancy up to 1 year post enrollmentUp to 1 year post-enrollmentIncidence 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 pregnancy up to 3 years post enrollmentUp to 3 year post-enrollmentIncidence 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 childbirth up to 1 year post enrollmentUp to 1 years post enrollmentIncidence 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 enrollmentUp to 3 years post enrollmentIncidence 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026