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NCT Number: NCT05216003

Pregnancy at a Time That Is Happy and Healthy for You

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Clinic Level Analysis:

  • women age 18-49
  • presenting for care at PATH4YOU clinic site

Exclusion criteria

  • history of hysterectomy or sterilization, or post-menopausal

Treatment and study plan

PATH4YOU

Behavioral

PATH4YOU offers patient-center, comprehensive, contraceptive counseling; pregnancy planning; and same to next day access to birth control. This clinical care program will reduce obstacles to contraception in Indiana and enables access to healthy pregnancy planning conversations.

Primary outcomes

  1. Participant Satisfaction with Shared Decision Making

    Time frame: Within 2-4 weeks of PATH4YOU service visit

    Participant satisfaction is measured by the validated CollaboRATE scale, which is a 3 question survey. Each question is rated on a 5 point Likert scale with a response range of "every effort was made" (1) to "no effort was made" (5).

  2. Participant Satisfaction with Same Day Contraception

    Time frame: Within 2-4 weeks of PATH4YOU service visit

    Participants will be asked to respond to a single question of whether they received their desired contraception on the day of the visit. Responses will be either yes or no.

  3. Quality of family planning services

    Time frame: Within 2-4 weeks of PATH4YOU service visit

    Quality of family planning services will be evaluated through the validated Patient Centered Contraceptive Counseling (PCCC) Measure. The PCCC is a 4 question survey. Each question is rated on a 5 point Likert scale with responses ranging from poor (1) to excellent (5). Individual participant scores may range from 4 to 20 (with higher scores reflecting higher quality of care). A proportion of patient responses (80%) is used to determine overall quality of services. Participants will be asked to complete the PCCC one time, within 2-4 weeks after they have received care through the PATH4YOU program. Total responses will then be aggregated to determine overall quality of services upon final participant completion, approximately 3 years after project initiation.

  4. Participant reported Pregnancy Intention

    Time frame: 3 months, 6 months, and 12 months

    Participants will complete the Parenting Attitudes Timing and How important (PATH) validated scale on pregnancy intention. The scale askes participants to express an opinion about having children (yes/no), to rate the importance of pregnancy on a 5 point Likert scale (from very important as a 1 to not at all important as a 5), and to estimate the timeframe in which intend to be pregnant (ranging from within 6 months to more than 5 years from now). Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.

  5. Receipt of Pre-Visit Birth Control Decision Aid

    Time frame: Within 2-4 weeks of PATH4YOU service visit

    Participants will be asked whether they received the decision aid and whether they used it prior to the visit.

  6. Continuation of Contraceptive Method

    Time frame: 3 months, 6 months, and 12 months

    Participants will be asked whether they are satisfied with, and continuation of, contraceptive method. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.

  7. Unintended pregnancy rate

    Time frame: 3 months, 6 months, and 12 months

    The number of unintended pregnancies within 1 year of enrollment will be assessed. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.

Secondary outcomes

  1. Number of women receiving PATH4YOU bundle

    Time frame: 3 years

    The number of participants in each county will be totaled.

  2. Impact of demographics and reproductive characteristics

    Time frame: 3 years

    The sociodemographic and reproductive characteristics of participants, including participant self-reported age, race, ethnicity, gender, orientation, type of insurance, and zip code, will be evaluated to determine potential correlation with contraceptive method choice.

  3. Contraceptive choice

    Time frame: 3 years

    Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: PATH4YOU

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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