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

Pregnancy Clinical Trial

— M-CARES  

Official title:

Michigan Contraceptive Access, Research, and Evaluation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03673007
• Other study ID #: M-CARES
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 26, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4633
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Planned Parenthood - Ann Arbor-West	Ann Arbor	Michigan
United States	Planned Parenthood - Detroit	Detroit	Michigan
United States	Planned Parenthood - Ferndale	Ferndale	Michigan
United States	Planned Parenthood - Grand Rapids	Grand Rapids	Michigan
United States	Planned Parenthood - Kalamazoo	Kalamazoo	Michigan
United States	Planned Parenthood - Lansing	Lansing	Michigan
United States	Planned Parenthood - Livonia	Livonia	Michigan
United States	Planned Parenthood - Traverse City	Traverse City	Michigan
United States	Planned Parenthood - Warren	Warren	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Opinion Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	100 days from enrollment
Primary	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)	100 days from enrollment
Primary	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)	Up to 1 year post enrollment
Primary	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.	Up to 1 year post-enrollment
Primary	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.	Up to 3 year post-enrollment
Primary	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.	Up to 1 years post enrollment
Primary	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.	Up to 3 years post enrollment