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

NCT ID: NCT07214012

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-10-14

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. 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.

Detailed Description

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.

Conditions

Short Interpregnancy Intervals; Maternal Health Disparities

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Joint contraceptive and couple communication education

Intervention Type: 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 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

Group Type: OTHER

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

Intervention Type: 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

Booster Check-ins (~30 minutes)

Telehealth/in-person (couple preference), ~6 weeks postpartum

Follow-up survey at the end of sessions

Group Type: OTHER

Check-ins to support continued partner support & communication

Intervention Type: 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.)

Telehealth/in-person (couple preference), ~12 weeks postpartum

Follow-up surveys at the end of session

Group Type: OTHER

Check-ins to support continued partner support & communication

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. > 20 weeks pregnant, age 18+

2. 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

3. separately, the pregnant person reports being in a sexually, psychologically and physically safe relationship

4. English-speaking

1. 18 years of age and older

2. Cohabiting with the patient; in a romantic relationship with patient

3. Capable of getting the patient pregnant after delivery

4. Does not need to be the biological father of the current pregnancy

5. English-speaking (in order to take part in the interview as the interviewer does not speak Spanish)

Exclusion Criteria

1. Participant is under the age of 18

2. Documented cognitive impairment or psychiatric condition in pregnant person's medical record (e.g., severe learning disability, dementia, current psychotic disorder, suicidality)

3. Participation in a concurrent contraceptive education intervention

4. The pregnant person has a high-risk medical condition

1. Less than 18 years of age

2. Are not cohabiting with the patient; not in a romantic relationship with patient

3. Not capable of getting the patient pregnant after delivery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Countries

United States

Facility Contacts

Patricia N.E. Roberson, PhD, Prinicipal Investigator

Role: primary

Proberson1@utmck.edu

(865) 305-9230

Other Identifiers

R21HD112736

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5175

Identifier Type: -

Identifier Source: org_study_id