Contraception BehaviorPATH4YOUNCT05216003
Pregnancy at a Time That Is Happy and Healthy for You
A study testing PATH4YOU in people with Contraception Behavior, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- PATH4YOU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women age 18-49
- presenting for care at PATH4YOU clinic site
Who cannot join
- history of hysterectomy or sterilization, or post-menopausal
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
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:
- 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
- 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.
- 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.
- Conditions
- Contraception Behavior
- Being tested
- PATH4YOU
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH4YOUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PATH4YOU County | Experimental | Not described Receives: Behavioral: PATH4YOU |
| Matched-Pair Control County | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction with Shared Decision Making
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).
Measured: Within 2-4 weeks of PATH4YOU service visit
Participant Satisfaction with Same Day Contraception
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.
Measured: Within 2-4 weeks of PATH4YOU service visit
Quality of family planning services
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.
Measured: Within 2-4 weeks of PATH4YOU service visit
Participant reported Pregnancy Intention
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.
Measured: 3 months, 6 months, and 12 months
Receipt of Pre-Visit Birth Control Decision Aid
Participants will be asked whether they received the decision aid and whether they used it prior to the visit.
Measured: Within 2-4 weeks of PATH4YOU service visit
Continuation of Contraceptive Method
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.
Measured: 3 months, 6 months, and 12 months
Unintended pregnancy rate
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.
Measured: 3 months, 6 months, and 12 months
Secondary outcomes (3)
Number of women receiving PATH4YOU bundle
The number of participants in each county will be totaled.
Measured: 3 years
Impact of demographics and reproductive characteristics
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.
Measured: 3 years
Contraceptive choice
Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start2 Sep 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey Wilkinson, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216003
- Sponsor's protocol ID
- 1909180276
- Acronym
- PATH4YOU
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No