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| ID | Type | Description | Link |
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| R21HD112736 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol
The hypothesis of this study are
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.
At 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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Communication and Contraceptive Education Workbook (60-90 minutes) | Other | Asynchronous (during times convenient to the couple) (21-30 weeks gestation) Follow-up survey at the end of session |
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| Couple Contraceptive Consultation (60-90 minutes) | Other | In-person at OBGYN appt or telehealth (couple preference). ~ 32 weeks gestation Follow-up survey at the end of session |
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| Booster Check-ins (~30 minutes) | Other | Telehealth/in-person (couple preference), ~6 weeks postpartum Follow-up survey at the end of sessions |
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| Booster Check-ins (~30 minutes.) | Other | Telehealth/in-person (couple preference), ~12 weeks postpartum Follow-up surveys at the end of session |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint contraceptive and couple communication education | Other | Joint Comprehensive Contraceptive Education a. Visual and written description of all currently available contraceptives with explanation of pros and cons Couple constructive communication education
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Acceptability of the Intervention | Measured by survey item: >80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| Change in Contraceptive Knowledge | Measured using the validated Contraceptive Knowledge tool | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| Change in Couple Communication Quality | Assessed with the Communication Problems Questionnaire (CPQ) | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Consistent Contraceptive Usage | Measured by participant self-report on the Consistent Usage scale | 6-week postpartum and 12-week postpartum |
| Satisfaction with Agreed Contraceptive Method | Assessed via the validated Satisfaction of Agreed Method scale |
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Inclusion Criteria:
Patient Inclusion Criteria:
Romantic Partner Inclusion Criteria:
Exclusion Criteria:
Patient Exclusion Criteria:
Romantic Partner Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Graduate School of Medicine | Recruiting | Knoxville | Tennessee | 37915 | United States |
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| Couple communication consultation with Interventionist to increase partner engagement and improve communication | Other |
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| Check-ins to support continued partner support & communication | Other |
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| Check-ins to support continued partner support & communication | Other |
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| 6-week postpartum and 12-week postpartum |
| Relationship Satisfaction | Measured using the Couple Satisfaction Index (CSI) | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| Psychological Distress - Anxiety | Measured using PROMIS Anxiety short form | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| Psychological Distress - Depression | Measured using PROMIS Depression short form | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |
| Relationship Aggression | Measured using the Conflict Tactic Scale (CTS) | Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum |