Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-02 @ 12:35 AM
Study NCT ID:
NCT05216003
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-27
First Post:
2022-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy at a Time That Is Happy and Healthy for You
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Satisfaction with Shared Decision Making', 'timeFrame': 'Within 2-4 weeks of PATH4YOU service visit', 'description': '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).'}, {'measure': 'Participant Satisfaction with Same Day Contraception', 'timeFrame': 'Within 2-4 weeks of PATH4YOU service visit', 'description': '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.'}, {'measure': 'Quality of family planning services', 'timeFrame': 'Within 2-4 weeks of PATH4YOU service visit', 'description': '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.'}, {'measure': 'Participant reported Pregnancy Intention', 'timeFrame': '3 months, 6 months, and 12 months', 'description': '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.'}, {'measure': 'Receipt of Pre-Visit Birth Control Decision Aid', 'timeFrame': 'Within 2-4 weeks of PATH4YOU service visit', 'description': 'Participants will be asked whether they received the decision aid and whether they used it prior to the visit.'}, {'measure': 'Continuation of Contraceptive Method', 'timeFrame': '3 months, 6 months, and 12 months', 'description': '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.'}, {'measure': 'Unintended pregnancy rate', 'timeFrame': '3 months, 6 months, and 12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of women receiving PATH4YOU bundle', 'timeFrame': '3 years', 'description': 'The number of participants in each county will be totaled.'}, {'measure': 'Impact of demographics and reproductive characteristics', 'timeFrame': '3 years', 'description': '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.'}, {'measure': 'Contraceptive choice', 'timeFrame': '3 years', 'description': 'Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception Behavior']}, 'descriptionModule': {'briefSummary': "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.\n\nThe health center level intervention will consist of three key principles:\n\n1. 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\n2. 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.\n3. 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Clinic Level Analysis:\n\n* women age 18-49\n* presenting for care at PATH4YOU clinic site\n\nExclusion Criteria:\n\n* history of hysterectomy or sterilization, or post-menopausal'}, 'identificationModule': {'nctId': 'NCT05216003', 'acronym': 'PATH4YOU', 'briefTitle': 'Pregnancy at a Time That Is Happy and Healthy for You', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Pregnancy at a Time That Is Happy and Healthy for You', 'orgStudyIdInfo': {'id': '1909180276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PATH4YOU County', 'interventionNames': ['Behavioral: PATH4YOU']}, {'type': 'NO_INTERVENTION', 'label': 'Matched-Pair Control County'}], 'interventions': [{'name': 'PATH4YOU', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['PATH4YOU County']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Obstetrics & Gynecology', 'investigatorFullName': 'Tracey Wilkinson', 'investigatorAffiliation': 'Indiana University'}}}}