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PATH4YOU: Pregnancy at a Time That Is Happy and Healthy for You

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05216003
Collaborator
(none)
1,000
Enrollment
1
Location
39
Anticipated Duration (Months)
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In an effort reduce maternal and infant mortality and health disparities overall, PATH4YOU (Pregnancy At a Time that's Healthy and Happy for You) will be implemented starting in Marion County, and will ultimately be a statewide comprehensive contraceptive access program that ensures that patient-centered counseling and same-day access to no (or low) cost contraception are delivered to women across the state. The goal of this project is to partner with community stakeholders to tailor and implement a patient-centered, comprehensive contraceptive access intervention, the PATH4YOU Bundle.

The health center level intervention will consist of three key principles:

  1. Pregnancy Intention Screening: Provide training for health care providers and assist in health center implementation of a patient-centered pregnancy intention screening strategy within clinical settings

  2. Contraception and Reproductive Health Counseling: Implement the use of a pre-visit patient-centered decision-aid for all patients presenting to a health center for reproductive health care.

  3. Same-Day Access to Contraception: Provide training for health care providers and logistical assistance to health centers to implement care consistent with providing patients with their chosen method of contraception the day of patient contact.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PATH4YOU

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pregnancy at a Time That Is Happy and Healthy for You
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Reduction of infant and maternal mortality and morbidity [2025]

    Review the infant and maternal mortality rates in counties throughout Indiana

Secondary Outcome Measures

  1. Patient satisfaction [2025]

    Measuring patient satisfaction with PATH4YOU as a program

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  • women

  • live in Indiana

Exclusion Criteria:
  • history of hysterectomy or sterilization or post-menopausal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Hospital Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey Peipert, Chair, Department of Obstetrics & Gynecology, Indiana University
ClinicalTrials.gov Identifier:
NCT05216003
Other Study ID Numbers:
  • 1909180276
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 31, 2022