CClinicalTrials.gg
Active, not recruitingNCT03673007M-CARESUpdated Jun 2, 2026

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

An interventional study of Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) and Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) in Pregnancy, sponsored by University of Michigan. Active, not recruiting at 9 sites in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by University of Michigan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
4,633
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Pregnancy

Keywords

  • contraception
  • financial access to reproductive health care
  • unintended pregnancy
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,633 participants (actual)

Study arms

  • Experimental
    Treatment Group

    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) · 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)

  • No intervention
    Control Group

    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.

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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 100 days from enrollment

  2. 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)

    Time frame: 100 days from enrollment

  3. 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)

    Time frame: Up to 1 year post enrollment

  4. 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.

    Time frame: Up to 1 year post-enrollment

  5. 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.

    Time frame: Up to 3 year post-enrollment

  6. 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.

    Time frame: Up to 1 years post enrollment

  7. 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.

    Time frame: Up to 3 years post enrollment

07

Study locations

9 sites
  • Planned Parenthood - Ann Arbor-West
    Ann Arbor, Michigan 48103, United States
  • Planned Parenthood - Detroit
    Detroit, Michigan 48201, United States
  • Planned Parenthood - Ferndale
    Ferndale, Michigan 48220, United States
  • Planned Parenthood - Grand Rapids
    Grand Rapids, Michigan 49503, United States
  • Planned Parenthood - Kalamazoo
    Kalamazoo, Michigan 49006, United States
  • Planned Parenthood - Lansing
    Lansing, Michigan 48912, United States
  • Planned Parenthood - Livonia
    Livonia, Michigan 48154, United States
  • Planned Parenthood - Traverse City
    Traverse City, Michigan 49686, United States
  • Planned Parenthood - Warren
    Warren, Michigan 48093, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03673007
Lead sponsor
University of Michigan
Collaborators
National Opinion Research Center
Responsible party
Martha Bailey (Adjunct Research Professor, Population Studies Center, Institute of Social Research, University of Michigan) — Principal investigator
First posted
Sep 17, 2018
Start date
Aug 26, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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