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Michigan Contraceptive Access, Research, and Evaluation Study (M-CARES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03673007
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
National Opinion Research Center
Information provided by (Responsible Party):
Martha Bailey, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy 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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Michigan Contraceptive Access, Research, and Evaluation Study
Actual Study Start Date : August 26, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : December 31, 2049

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
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.

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)
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.
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673007


Contacts
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Contact: Vanessa Lang, PhD 1-844-864-8258 m-carestudy@umich.edu

Locations
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United States, Michigan
Planned Parenthood - Ann Arbor-West Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Detroit Recruiting
Detroit, Michigan, United States, 48201
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Ferndale Recruiting
Ferndale, Michigan, United States, 48220
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Kalamazoo Recruiting
Kalamazoo, Michigan, United States, 49006
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Lansing Recruiting
Lansing, Michigan, United States, 48912
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Livonia Recruiting
Livonia, Michigan, United States, 48154
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Traverse City Recruiting
Traverse City, Michigan, United States, 49686
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Planned Parenthood - Warren Recruiting
Warren, Michigan, United States, 48093
Contact: Suni Jo Roberts    734-926-4802    SuniJo.Roberts@ppmi.org   
Sponsors and Collaborators
University of Michigan
National Opinion Research Center
More Information
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Responsible Party: Martha Bailey, Professor of Economics, Research Professor-Institute of Social Research, University of Michigan
ClinicalTrials.gov Identifier: NCT03673007    
Other Study ID Numbers: M-CARES
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martha Bailey, University of Michigan:
contraception
financial access to reproductive health care
unintended pregnancy
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs