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

Not Applicable

Recruiting

• Conditions: Pregnancy
• Interventions: 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)

• Registration Number: NCT04371900
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-26
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2049-12-31
• Study Completion: 2049-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4700

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)	Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives
Experimental Group	Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)	Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

Primary Outcome Measures

Name	Time	Method
Standardized achievement test score (5 year)	Up to 5 year post enrollment	Percentile on state standardized achievement test (range: 1-100)
Number of siblings born after study enrollment (5 year)	Up to 5 year post enrollment	Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Standardized achievement test score (1 year)	Up to 1 year post enrollment	Percentile on state standardized achievement test (range: 1-100)
Standardized achievement test score (3 year)	Up to 3 year post enrollment	Percentile on state standardized achievement test (range: 1-100)
Number of siblings born after study enrollment (1 year)	Up to 1 year post enrollment	Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Number of siblings born after study enrollment (3 year)	Up to 3 year post enrollment	Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)

Trial Locations

Locations (9)

Planned Parenthood - Detroit; 🇺🇸 Detroit, Michigan, United States

Planned Parenthood - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

Planned Parenthood - Lansing; 🇺🇸 Lansing, Michigan, United States

Planned Parenthood - Traverse City; 🇺🇸 Traverse City, Michigan, United States

Planned Parenthood - Warren; 🇺🇸 Warren, Michigan, United States

Planned Parenthood - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

Planned Parenthood - Ferndale; 🇺🇸 Ferndale, Michigan, United States

Planned Parenthood - Livonia; 🇺🇸 Livonia, Michigan, United States

Planned Parenthood - Ann Arbor-West; 🇺🇸 Ann Arbor, Michigan, United States