Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families
Part of paid clinical trials in Knoxville, Tennessee.
- Sponsor
- University of Tennessee Graduate School of Medicine
- Study ID
- NCT07214012
- Status
- Recruiting
Conditions
- Maternal Health Disparities
- Short Interpregnancy Intervals
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Joint contraceptive and couple communication education — OTHERJoint Comprehensive Contraceptive Education a. Visual and written description of all currently available contraceptives with explanation of pros and cons Couple constructive communication education 1. Specific couple contraceptive conversation examples. 2. Interactive worksheet to help with joint desired contraceptive decision-making and making a consistent use plan
- Couple communication consultation with Interventionist to increase partner engagement and improve communication — OTHER1. Couples will bring their completed workbook to reference during the meeting and assess fidelity 2. Reinforce couple contraceptive communication skills. Address any challenges couple has with skill implementation 3. Review desired contraceptive method \& consistent use plan 4. Use motivational interviewing techniques to help couple agree on contraceptive plan
- Check-ins to support continued partner support & communication — OTHER1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method 2. Assess factors promoting successful contraceptive use and communication skills 3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving
- Check-ins to support continued partner support & communication — OTHER1. Review progress toward couple contraceptive communication skills and use of agreed contraceptive method 2. Assess factors promoting successful contraceptive use and communication skills 3. Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving
Study Details
The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol The hypothesis of this study are 1. 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) 2. The intervention will be acceptable, with \>80% of participants reporting satisfaction with Planning Together. 3. 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.
Key Dates
- Start date
- Nov 25, 2025
- Status verified
- Oct 2025
- Primary completion
- Oct 14, 2026
- Completion
- Oct 14, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Other: Communication and Contraceptive Education Workbook (60-90 minutes)Asynchronous (during times convenient to the couple) (21-30 weeks gestation) Follow-up survey at the end of session
- Other: Couple Contraceptive Consultation (60-90 minutes)In-person at OBGYN appt or telehealth (couple preference). \~ 32 weeks gestation Follow-up survey at the end of session
- Other: Booster Check-ins (~30 minutes)Telehealth/in-person (couple preference), \~6 weeks postpartum Follow-up survey at the end of sessions
- Other: Booster Check-ins (~30 minutes.)Telehealth/in-person (couple preference), \~12 weeks postpartum Follow-up surveys at the end of session
Primary Outcome Measure
Feasibility of Study Procedures [ Time Frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Tennessee Graduate School of Medicine | Knoxville | Tennessee | 37915 |