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 — 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 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 — OTHER
    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
  • Check-ins to support continued partner support & communication — OTHER
    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
  • Check-ins to support continued partner support & communication — OTHER
    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

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)

FacilityCityStateZIPSite coordinators
University of Tennessee Graduate School of MedicineKnoxvilleTennessee37915
Patricia N.E. Roberson, PhD, Prinicipal Investigator
(865) 305-9230

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