Ann Arbor, Michigan 48103


Purpose:

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.


Criteria:

Inclusion Criteria: M-CARES will recruit 5,000 women at Michigan Planned Parenthood of Michigan (PPMI) clinics over at least 12 months 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, and 5. . at a PPMI clinic for a clinician appointment.


Study is Available At:


Original ID:

M-CARES


NCT ID:

NCT03673007


Secondary ID:


Study Acronym:

M-CARES


Brief Title:

Michigan Contraceptive Access, Research, and Evaluation Study


Official Title:

Michigan Contraceptive Access, Research, and Evaluation Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

5000


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Stephanie Hart, MS
1-844-864-8258
m-carestudy@umich.edu

Study Dates

Start Date:September 12, 2018
Completion Date:December 31, 2049
Completion Type:Anticipated
Primary Completion Date:August 31, 2019
Primary Completion Type:Anticipated
Verification Date:September 2018
Last Changed Date:September 12, 2018
First Received Date:August 15, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:The impact of subsidies for contraceptives on contraceptive efficacy as determined by a standardized index
Time Frame:1 year
Safety Issues:False
Description:We will examine a standardized index created from the following measures: total contraceptive expenditures at PPMI, any contraceptive use, temporal coverage of contraceptive method (e.g., 1 day, 3 months, 6 months, 12 months), use of a high efficacy metho
Outcome Type:Primary Outcome
Measure:The impact of subsidies for contraceptives on unintended pregnancy and childbearing as determined by a standardized index
Time Frame:1 year
Safety Issues:False
Description:A standardized index to measure the impact of subsidies on unintended pregnancy and childbearing will be developed by using participant survey data and administrative data to examine the following variables: number of pregnancies, number of pregnancy test
Outcome Type:Secondary Outcome
Measure:The impact of subsidies for contraceptives on economic self-sufficiency as determined by a standardized index
Time Frame:1 year
Safety Issues:False
Description:A standardized index to measure the impact of subsidies on economic self-sufficiency will be developed by using participant survey data and administrative data to examine the following variables: wage earnings, enrollment in college or education, employed
Outcome Type:Secondary Outcome
Measure:The impact of subsidies for contraceptives on financial security as determined by a standardized index
Time Frame:1 year
Safety Issues:False
Description:A standardized index to measure the impact of subsidies for contraceptives on financial security will be developed by using participant survey data and administrative data to examine the following variables: reverse coded (-1*) bills sent to collection; r
Outcome Type:Secondary Outcome
Measure:The impact of subsidies for contraceptives on neighborhood quality as determined by a standardized index
Time Frame:1 year
Safety Issues:False
Description:A standardized index to measure the impact of subsidies on neighborhood quality will be developed by using participant survey data and administrative data to examine the following variables: income-to-poverty ratio in census tract of residence; reverse co

Study Interventions

Intervention Type:Behavioral
Name:Gift card to be used for contraceptives
Description:M-CARES will randomize allocation of vouchers (gift cards) for contraception.
Arm Name:Contraceptive Voucher (Gift Card)

Study Arms

Study Arm Type:Experimental
Arm Name:Contraceptive Voucher (Gift Card)
Description:Women in this arm of the study receive a contraceptive gift card.
Study Arm Type:No Intervention
Arm Name:No Contraceptive Voucher (Gift Card)
Description:Women in this arm of the study DO NOT receive a contraceptive gift card.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Opinion Research Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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