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Pregnancy at a Time That Is Happy and Healthy for You

Pregnancy at a Time That Is Happy and Healthy for You

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05216003
Acronym
PATH4YOU
Enrollment
1200
Registered
2022-01-31
Start date
2021-09-02
Completion date
2026-12-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Behavior

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.

Interventions

BEHAVIORALPATH4YOU

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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study will evaluate matched-pair counties in a step-wedge design. As the intervention is implemented within a particular Indiana county, researchers will identify a matching Indiana county based on infant mortality rate. At the end of each year post-implementation, data will be compared between the intervention county and the match-paired county.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Participant Satisfaction with Shared Decision MakingWithin 2-4 weeks of PATH4YOU service visitParticipant 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).
Participant Satisfaction with Same Day ContraceptionWithin 2-4 weeks of PATH4YOU service visitParticipants 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.
Quality of family planning servicesWithin 2-4 weeks of PATH4YOU service visitQuality 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.
Participant reported Pregnancy Intention3 months, 6 months, and 12 monthsParticipants 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.
Receipt of Pre-Visit Birth Control Decision AidWithin 2-4 weeks of PATH4YOU service visitParticipants will be asked whether they received the decision aid and whether they used it prior to the visit.
Continuation of Contraceptive Method3 months, 6 months, and 12 monthsParticipants 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.
Unintended pregnancy rate3 months, 6 months, and 12 monthsThe 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

MeasureTime frameDescription
Number of women receiving PATH4YOU bundle3 yearsThe number of participants in each county will be totaled.
Impact of demographics and reproductive characteristics3 yearsThe 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.
Contraceptive choice3 yearsOf the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026