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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2031
  • participants needed
    2450
  • sponsor
    University of Michigan
Updated on 13 March 2022
Accepts healthy volunteers

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.

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.

Details
Condition Pregnancy
Treatment Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-December 31, 2021), Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019), Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
Clinical Study IdentifierNCT04371900
SponsorUniversity of Michigan
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
-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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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