About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Joint contraceptive and couple communication education
Other interventionJoint 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 intervention1. 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 intervention1. 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 intervention1. 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Acceptability of the Intervention
Measured by survey item: \>80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire
Change in Contraceptive Knowledge
Measured using the validated Contraceptive Knowledge tool
Change in Couple Communication Quality
Assessed with the Communication Problems Questionnaire (CPQ)
Secondary outcomes
Consistent Contraceptive Usage
Measured by participant self-report on the Consistent Usage scale
Satisfaction with Agreed Contraceptive Method
Assessed via the validated Satisfaction of Agreed Method scale
Relationship Satisfaction
Measured using the Couple Satisfaction Index (CSI)
Psychological Distress - Anxiety
Measured using PROMIS Anxiety short form
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Tennessee Graduate School of Medicine
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator