An interventional study of PATH4YOU in Contraception Behavior, sponsored by Indiana University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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:
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 1,200 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: PATH4YOU
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months, 6 months, and 12 months
Number of women receiving PATH4YOU bundle
The number of participants in each county will be totaled.
Time frame: 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.
Time frame: 3 years
Contraceptive choice
Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.
Time frame: 3 years
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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