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

N/AActive Not RecruitingNCT03673007

University of Michigan4,633 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

4,633

Conditions

Pregnancy

Interventions

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)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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

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, United States

Outcomes

Primary Outcomes

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

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

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

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

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

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

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