Clinical trial NCT03673007: Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1
Official title: Michigan Contraceptive Access, Research, and Evaluation Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: contraception
financial access to reproductive health care
unintended pregnancy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Opinion Research Center
First posted: 2018-09-17
Enrollment: 4633
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

M-CARES will recruit 5,000 women at Michigan Planned Parenthood of Michigan (PPMI) clinics 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

Primary outcomes:
measure: Incidence of patients billing for use of any contraception (1 for use of contraception/0 no use of contraception)
timeFrame: 100 days from enrollment
measure: Incidence of patients billing for long-run acting, reversible contraception (LARC) (0 no use of LARC/1 for use of LARC)
timeFrame: 100 days from enrollment
measure: Incidence of patients billing for long-run acting, reversible contraception (LARC) (0 no use of LARC/1 for use of LARC)
timeFrame: Up to 1 year post enrollment
measure: Incidence of pregnancy up to 1 year post enrollment
timeFrame: Up to 1 year post-enrollment
measure: Incidence of pregnancy up to 3 years post enrollment
timeFrame: Up to 3 year post-enrollment
measure: Incidence of childbirth up to 1 year post enrollment
timeFrame: Up to 1 years post enrollment
measure: Incidence of childbirth up to 3 year post enrollment
timeFrame: Up to 3 years post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Planned Parenthood - Ann Arbor-West
state: Michigan
city: Detroit
country: United States
facility: Planned Parenthood - Detroit
state: Michigan
city: Ferndale
country: United States
facility: Planned Parenthood - Ferndale
state: Michigan
city: Grand Rapids
country: United States
facility: Planned Parenthood - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: Planned Parenthood - Kalamazoo
state: Michigan
city: Lansing
country: United States
facility: Planned Parenthood - Lansing
state: Michigan
city: Livonia
country: United States
facility: Planned Parenthood - Livonia
state: Michigan
city: Traverse City
country: United States
facility: Planned Parenthood - Traverse City
state: Michigan
city: Warren
country: United States
facility: Planned Parenthood - Warren
state: Michigan
Study officials:
References: