What this study is
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.
What's being tested
- Joint contraceptive and couple communication education
Intervention · 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
Intervention · 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
Intervention · OTHER
- Check-ins to support continued partner support & communication
Intervention · OTHER
Both Check-ins to support continued partner support & communication and 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
Study details
- Sponsor
- University of Tennessee Graduate School of Medicine
- Conditions
- Short Interpregnancy Intervals · Maternal Health Disparities
- Enrolling
- 60 people
- Starts
- 2025-11-25
- Est. completion
- 2026-10-14
- Design
- Open-label, non-randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedPatient
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
You can't join 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
Romantic Partner
You may qualify if
- 18 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 can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States
- Patricia N.E. Roberson, PhD, Prinicipal Investigator · Contact(865) 305-9230Proberson1@utmck.edu
Recruiting
Study team
Sponsor
University of Tennessee Graduate School of Medicine
Study ID 5175
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.