[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609394":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":53,"studyPopulation":46,"armGroups":54,"interventions":74,"overallOfficials":46,"centralContacts":46,"locations":89,"responsibleParty":109,"collaborators":111,"id":115,"slug":46,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":46,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":46,"enrollmentInfo":123,"targetDuration":46,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":46,"overallStatus":91,"whyStopped":46,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":46},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Study Procedures","Defined as ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% fidelity (completion of workbook and study activities)","Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum",{"measure":14,"description":15,"timeFrame":12},"Acceptability of the Intervention","Measured by survey item: \\>80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire",{"measure":17,"description":18,"timeFrame":12},"Change in Contraceptive Knowledge","Measured using the validated Contraceptive Knowledge tool",{"measure":20,"description":21,"timeFrame":12},"Change in Couple Communication Quality","Assessed with the Communication Problems Questionnaire (CPQ)",{"measure":23,"description":24,"timeFrame":25},"Community Referral Utilization","Community Referral Utilization and Satisfaction Questionnaire Scale (4 items validated by Dr. Roberson with economically marginalized couples","32 weeks gestation to 12 weeks postpartum",[27,31,34,37,40,43],{"measure":28,"description":29,"timeFrame":30},"Consistent Contraceptive Usage","Measured by participant self-report on the Consistent Usage scale","6-week postpartum and 12-week postpartum",{"measure":32,"description":33,"timeFrame":30},"Satisfaction with Agreed Contraceptive Method","Assessed via the validated Satisfaction of Agreed Method scale",{"measure":35,"description":36,"timeFrame":12},"Relationship Satisfaction","Measured using the Couple Satisfaction Index (CSI)",{"measure":38,"description":39,"timeFrame":12},"Psychological Distress - Anxiety","Measured using PROMIS Anxiety short form",{"measure":41,"description":42,"timeFrame":12},"Psychological Distress - Depression","Measured using PROMIS Depression short form",{"measure":44,"description":45,"timeFrame":12},"Relationship Aggression","Measured using the Conflict Tactic Scale (CTS)",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"NON_RANDOMIZED","SINGLE_GROUP","PREVENTION",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE","This study addresses critical maternal health disparities by targeting SII, which are associated with adverse outcomes such as preterm birth, low birth weight, and preeclampsia. These risks are especially high in economically marginalized populations, particularly in the Southern U.S., where access to prenatal contraceptive education is limited. The \"Planning Together\" intervention is a culturally-responsive, couple-based approach that seeks to improve consistent, desired contraceptive use by addressing both social barriers (e.g., lack of partner involvement and poor communication) and structural barriers (e.g., food insecurity, housing instability). It combines flexible delivery (online and in-person options) with tailored community referrals and partner-inclusive contraceptive education.\n\nAt approximately 20 weeks gestation, eligible pregnant participants will be recruited from the UT OBGYN Clinic, with their romantic partners recruited in-person or virtually. After informed consent, both participants will complete a baseline survey. This survey includes demographics and validated measures related to contraceptive knowledge, couple communication, reproductive autonomy, and psychological well-being. The visit also includes a social needs assessment using the Accountable Health Communities Screening Tool, which informs warm hand-off referrals during later sessions.\n\nThe significance of this work lies in its potential to reduce maternal health disparities through a brief (4-session), sustainable intervention model. If proven feasible and acceptable, \"Planning Together\" could be scaled to other underserved or marginalized communities and applied to additional perinatal health issues traditionally assigned to the pregnant-capable person (e.g., infant vaccinations, breastfeeding, peripartum mood disorders), ultimately improving both infant and maternal health outcomes.",[55,60,65,70],{"label":56,"type":6,"description":57,"interventionNames":58},"Communication and Contraceptive Education Workbook (60-90 minutes)","Asynchronous (during times convenient to the couple) (21-30 weeks gestation)\n\nFollow-up survey at the end of session",[59],"Other: Joint contraceptive and couple communication education",{"label":61,"type":6,"description":62,"interventionNames":63},"Couple Contraceptive Consultation (60-90 minutes)","In-person at OBGYN appt or telehealth (couple preference). \\~ 32 weeks gestation\n\nFollow-up survey at the end of session",[64],"Other: Couple communication consultation with Interventionist to increase partner engagement and improve communication",{"label":66,"type":6,"description":67,"interventionNames":68},"Booster Check-ins (~30 minutes)","Telehealth\u002Fin-person (couple preference), \\~6 weeks postpartum\n\nFollow-up survey at the end of sessions",[69],"Other: Check-ins to support continued partner support & communication",{"label":71,"type":6,"description":72,"interventionNames":73},"Booster Check-ins (~30 minutes.)","Telehealth\u002Fin-person (couple preference), \\~12 weeks postpartum\n\nFollow-up surveys at the end of session",[69],[75,79,83,87],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":46},"Joint contraceptive and couple communication education","Joint Comprehensive Contraceptive Education\n\na. Visual and written description of all currently available contraceptives with explanation of pros and cons\n\nCouple constructive communication education\n\n1. Specific couple contraceptive conversation examples.\n2. Interactive worksheet to help with joint desired contraceptive decision-making and making a consistent use plan",[56],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":46},"Couple communication consultation with Interventionist to increase partner engagement and improve communication","1. Couples will bring their completed workbook to reference during the meeting and assess fidelity\n2. Reinforce couple contraceptive communication skills. Address any challenges couple has with skill implementation\n3. Review desired contraceptive method \\& consistent use plan\n4. Use motivational interviewing techniques to help couple agree on contraceptive plan",[61],{"type":6,"name":84,"description":85,"armGroupLabels":86,"otherNames":46},"Check-ins to support continued partner support & communication","1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method\n2. Assess factors promoting successful contraceptive use and communication skills\n3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving",[66],{"type":6,"name":84,"description":85,"armGroupLabels":88,"otherNames":46},[71],[90],{"facility":5,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"RECRUITING","Knoxville","Tennessee","37915","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-83.92074,35.96064,{"lat":101,"lon":100},[104],{"name":105,"role":106,"phone":107,"phoneExt":46,"email":108},"Patricia N.E. Roberson, PhD, Prinicipal Investigator","CONTACT","(865) 305-9230","Proberson1@utmck.edu",{"type":110,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[112],{"name":113,"class":114},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100609394",false,"NCT07214012","Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families","Inclusion Criteria:\n\nPatient Inclusion Criteria:\n\n1. \\> 20 weeks pregnant, age 18+\n2. The pregnant person has an available romantic partner, and the couple was able to get pregnant on their own or will be able to after the delivery\n3. separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship\n4. English-speaking\n\nRomantic Partner Inclusion Criteria:\n\n1. 18 years of age and older\n2. Cohabiting with the patient; in a romantic relationship with patient\n3. Capable of getting the patient pregnant after delivery\n4. Does not need to be the biological father of the current pregnancy\n5. English-speaking (in order to take part in the interview as the interviewer does not speak Spanish)\n\nExclusion Criteria:\n\nPatient Exclusion Criteria:\n\n1. Participant is under the age of 18\n2. Documented cognitive impairment or psychiatric condition in pregnant person's medical record (e.g., severe learning disability, dementia, current psychotic disorder, suicidality)\n3. Participation in a concurrent contraceptive education intervention\n4. The pregnant person has a high-risk medical condition\n\nRomantic Partner Exclusion Criteria:\n\n1. Less than 18 years of age\n2. Are not cohabiting with the patient; not in a romantic relationship with patient\n3. Not capable of getting the patient pregnant after delivery",true,"ALL","18 Years",{"count":124,"type":125},60,"ESTIMATED","INTERVENTIONAL",[128],"NA","The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol\n\nThe hypothesis of this study are\n\n1. The study will achieve feasibility, demonstrated by ≥80% study accrual (30 couples in 8 months), ≥75% protocol adherence, and ≥75% (e.g., education workbook completion)\n2. The intervention will be acceptable, with \\>80% of participants reporting satisfaction with Planning Together.\n3. Patterns of primary outcomes (contraceptive knowledge, communication quality, community referral utilization) and secondary outcomes (agreed contraceptive plan, consistent contraceptive usage and satisfaction, psychological distress, and Short Interpregnancy Intervals \\[SII\\]) will suggest benefits of the intervention.",[131,132],"Short Interpregnancy Intervals","Maternal Health Disparities","2026-05-13",{"date":135,"type":136},"2026-05-18","ACTUAL",{"date":138,"type":136},"2025-11-25",{"date":140,"type":125},"2026-10-14",{"name":5,"class":6},1]