Recruiting

Planning Together

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07214012

Conditions

Short Interpregnancy Intervals

Maternal Health Disparities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Joint contraceptive and couple communication education

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

Check-ins to support continued partner support & communication

Check-ins to support continued partner support & communication

Study Details

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.

Conditions

Short Interpregnancy Intervals

Maternal Health Disparities

Study ID

NCT07214012

Start date

Nov 25, 2025

Status verified date

Oct, 2025

Completion date

Oct 14, 2026

Anticipated

Primary completion date

Oct 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patient 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

Romantic Partner Inclusion Criteria:

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:

Patient 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

Romantic Partner Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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

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

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

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

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

Primary outcome measure

  • Feasibility of Study Procedures [ Time Frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum ]
  • Acceptability of the Intervention [ Time Frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum ]
  • Change in Contraceptive Knowledge [ Time Frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum ]
  • Change in Couple Communication Quality [ Time Frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum ]
  • Community Referral Utilization [ Time Frame: 32 weeks gestation to 12 weeks postpartum ]

Central Contacts and Locations

Locations

University of Tennessee Graduate School of Medicine

Recruiting

Knoxville, Tennessee, United States, 37915

Contacts

Patricia N.E. Roberson, PhD, Prinicipal Investigator

(865) 305-9230Proberson1@utmck.edu

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

May 18, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2026-05-18.