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

NCT03673007 | Active Not Recruiting

• 1 other identifier: M-CARES
• Study Type: interventional
• Target: 4,633
• Locations: 1 country
• Sites: 9

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.

Conditions

Pregnancy

Keywords

contraception; financial access to reproductive health care; unintended pregnancy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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

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.

Treatment Group

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Opinion Research Center: collaborator

Study Sites (9)

Planned Parenthood - Ann Arbor-West

Ann Arbor, Michigan, 48103, United States

Location

Planned Parenthood - Detroit

Detroit, Michigan, 48201, United States

Location

Planned Parenthood - Ferndale

Ferndale, Michigan, 48220, United States

Location

Planned Parenthood - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Planned Parenthood - Kalamazoo

Kalamazoo, Michigan, 49006, United States

Location

Planned Parenthood - Lansing

Lansing, Michigan, 48912, United States

Location

Planned Parenthood - Livonia

Livonia, Michigan, 48154, United States

Location

Planned Parenthood - Traverse City

Traverse City, Michigan, 49686, United States

Location

Planned Parenthood - Warren

Warren, Michigan, 48093, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Research Professor, Population Studies Center, Institute of Social Research

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 17, 2018
• Study Start: August 26, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)