Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1 (M-CARES)

April 21, 2023 updated by: Martha Bailey, University of Michigan

Michigan Contraceptive Access, Research, and Evaluation Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4633

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
100 days from enrollment
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)
100 days from enrollment
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)
Up to 1 year post enrollment
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.
Up to 1 year post-enrollment
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.
Up to 3 year post-enrollment
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.
Up to 1 years post enrollment
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.
Up to 3 years post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Opinion Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2018

Primary Completion (Anticipated)

December 31, 2028

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-CARES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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