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

University of Michigan

Status: Enrolling

Conditions: Pregnancy

Treatments: Behavioral: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019); Behavioral: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)

Study type: Interventional

Funder types: Other

Identifiers

NCT04371900

HUM00132909B

Details and patient eligibility

About

This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

Full description

M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.

Enrollment: 4,700 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

The proposed project will analyze the outcomes of children ages 0 to 17 years old whose mothers enrolled in the Michigan Contraceptive Access, Research and Evaluation Study (M-CARES). M-CARES participation requires that mothers are:

• 18-35 years old
• physically capable (biologically female and fecund) and at risk of having a pregnancy,
• not pregnant at the time of enrollment
• not wishing to become pregnant in the 12 months after enrollment,
• are seeking care at Planned Parenthood of Michigan, and
• face out-of-pocket costs for contraceptives at Planned Parenthood of Michigan.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,700 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

Treatment:

Behavioral: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)

Behavioral: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)

Control Group

No Intervention group

Description:

Mothers randomized to NOT receive a voucher. Mothers in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale.