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

University of Michigan

Status: Active, not recruiting

Conditions: Pregnancy

Treatments: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT03673007

M-CARES

Details and patient eligibility

About

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.

Enrollment: 4,633 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,633 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood

Treatment:

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)

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)

Control Group

No Intervention group

Description:

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.