Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families

NCT07214012 | Not Yet Recruiting

• 2 other identifiers: 5175R21HD112736
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The intervention will be acceptable, with \>80% of participants reporting satisfaction with Planning Together.
3. 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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (6)

• Consistent Contraceptive Usage

  6-week postpartum and 12-week postpartum

• Satisfaction with Agreed Contraceptive Method

  6-week postpartum and 12-week postpartum

• Relationship Satisfaction

  Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

• Psychological Distress - Anxiety

  Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

• Psychological Distress - Depression

  Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

Study Arms (4)

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

Other: Joint contraceptive and couple communication education

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

Other: Couple communication consultation with Interventionist to increase partner engagement and improve communication

Booster Check-ins (~30 minutes)

OTHER

Telehealth/in-person (couple preference), \~6 weeks postpartum Follow-up survey at the end of sessions

Other: Check-ins to support continued partner support & communication

Booster Check-ins (~30 minutes.)

OTHER

Telehealth/in-person (couple preference), \~12 weeks postpartum Follow-up surveys at the end of session

Other: Check-ins to support continued partner support & communication

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

Communication and Contraceptive Education Workbook (60-90 minutes)

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

Couple Contraceptive Consultation (60-90 minutes)

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

Booster Check-ins (~30 minutes)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 20 weeks pregnant, age 18+
• 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
• separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship
• English-speaking
• years of age and older
• Cohabiting with the patient; in a romantic relationship with patient
• Capable of getting the patient pregnant after delivery
• Does not need to be the biological father of the current pregnancy
• English-speaking (in order to take part in the interview as the interviewer does not speak Spanish)

You may not qualify if:

• Participant is under the age of 18
• Documented cognitive impairment or psychiatric condition in pregnant person's medical record (e.g., severe learning disability, dementia, current psychotic disorder, suicidality)
• Participation in a concurrent contraceptive education intervention
• The pregnant person has a high-risk medical condition
• Less than 18 years of age
• Are not cohabiting with the patient; not in a romantic relationship with patient
• Not capable of getting the patient pregnant after delivery

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37915, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)