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

NCT04371900 | Recruiting

• 1 other identifier: HUM00132909B
• Study Type: interventional
• Target: 4,700
• Locations: 1 country
• Sites: 9

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.

Conditions

Pregnancy

Keywords

contraception; financial access to reproductive health care; unintended pregnancy

Outcome Measures

Primary Outcomes (6)

• Number of siblings born after study enrollment (1 year)

  Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)

  Up to 1 year post enrollment

• Number of siblings born after study enrollment (3 year)

  Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)

  Up to 3 year post enrollment

• Number of siblings born after study enrollment (5 year)

  Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)

  Up to 5 year post enrollment

• Standardized achievement test score (1 year)

  Percentile on state standardized achievement test (range: 1-100)

  Up to 1 year post enrollment

• Standardized achievement test score (3 year)

  Percentile on state standardized achievement test (range: 1-100)

  Up to 3 year post enrollment

• Standardized achievement test score (5 year)

  Percentile on state standardized achievement test (range: 1-100)

  Up to 5 year post enrollment

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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

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.

Interventions

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

M-CARES randomized vouchers 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 from March 4, 2019, forward.

Experimental Group

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

M-CARES randomized vouchers 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 after November 4, 2019.

Experimental Group

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Planned Parenthood Federation of America: collaborator
• National Opinion Research Center: collaborator

Study Sites (9)

Planned Parenthood - Ann Arbor-West

Ann Arbor, Michigan, 48103, United States

RECRUITING

Planned Parenthood - Detroit

Detroit, Michigan, 48201, United States

RECRUITING

Planned Parenthood - Ferndale

Ferndale, Michigan, 48220, United States

RECRUITING

Planned Parenthood - Grand Rapids

Grand Rapids, Michigan, 49503, United States

RECRUITING

Planned Parenthood - Kalamazoo

Kalamazoo, Michigan, 49006, United States

RECRUITING

Planned Parenthood - Lansing

Lansing, Michigan, 48912, United States

RECRUITING

Planned Parenthood - Livonia

Livonia, Michigan, 48154, United States

RECRUITING

Planned Parenthood - Traverse City

Traverse City, Michigan, 49686, United States

RECRUITING

Planned Parenthood - Warren

Warren, Michigan, 48093, United States

RECRUITING

Central Study Contacts

Vanessa Lang, PhD

CONTACT

1-844-864-8258; m-carestudy@umich.edu

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

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: August 26, 2018
• Primary Completion (Estimated): December 31, 2049
• Study Completion (Estimated): December 31, 2049
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)