Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families
NCT07214012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-18
Summary
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.
Conditions
- Short Interpregnancy Intervals
- Maternal Health Disparities
Interventions
- OTHER
-
Joint contraceptive and couple communication education
Joint 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
- OTHER
-
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 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
- OTHER
-
Check-ins to support continued partner support & communication
1. 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
- OTHER
-
Check-ins to support continued partner support & communication
1. 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
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of Tennessee Graduate School of Medicine
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-25
- Primary Completion
- 2026-10-14
- Completion
- 2026-10-14
Countries
- United States
Study Locations
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