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Active, Not Recruiting

NCT Number: NCT03673007

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood - Ann Arbor-West, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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

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.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 100 days from 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) within 100 days of enrollment (0 for no use of contraception; 1 for use of contraception)

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

    Time frame: 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)

  4. Incidence of pregnancy up to 1 year post enrollment

    Time frame: 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.

  5. Incidence of pregnancy up to 3 years post enrollment

    Time frame: 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.

  6. Incidence of childbirth up to 1 year post enrollment

    Time frame: 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.

  7. Incidence of childbirth up to 3 year post enrollment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Opinion Research Center

Registry information

Official study title

Michigan Contraceptive Access, Research, and Evaluation Study

Acronym: M-CARES

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2018
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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