Short Interpregnancy IntervalsNCT07214012
Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families
A study testing Joint contraceptive and couple communication education, Couple communication consultation with Interventionist to increase partner engagement and improve communication and Check-ins to support continued partner support & communication in people with Short Interpregnancy Intervals and Maternal Health Disparities, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Short Interpregnancy Intervals, Maternal Health Disparities
- What is being tested?
- Joint contraceptive and couple communication education, Couple communication consultation with Interventionist to increase partner engagement and improve communication and Check-ins to support continued partner support & communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria:
- > 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
- Romantic Partner Inclusion Criteria:
Show all 11Show fewer
- 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)
Who cannot join
- Patient Exclusion Criteria:
- 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 Exclusion Criteria:
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37915
Patricia N.E. Roberson, PhD, Prinicipal Investigator, (865) 305-9230, Proberson1@utmck.edu
About this study
The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol
The hypothesis of this study are
- 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)
- The intervention will be acceptable, with >80% of participants reporting satisfaction with Planning Together.
- 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.
Read the 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.
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint contraceptive and couple communication educationOther
Joint Comprehensive Contraceptive Education
- Visual and written description of all currently available contraceptives with explanation of pros and cons
Couple constructive communication education
- Specific couple contraceptive conversation examples.
- 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 communicationOther
- Couples will bring their completed workbook to reference during the meeting and assess fidelity
- Reinforce couple contraceptive communication skills. Address any challenges couple has with skill implementation
- Review desired contraceptive method \& consistent use plan
- Use motivational interviewing techniques to help couple agree on contraceptive plan
Check-ins to support continued partner support & communicationOther
- Review progress toward couple contraceptive communication skills and use of agreed contraceptive method
- Assess factors promoting successful contraceptive use and communication skills
- Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving
Check-ins to support continued partner support & communicationOther
- Review progress toward couple contraceptive communication skills and use of agreed contraceptive method
- Assess factors promoting successful contraceptive use and communication skills
- Address barriers to consistent contraceptive use and communication skill implementation via shared problem-solving
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Check-ins to support continued partner support & communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 32 weeks gestation to 12 weeks postpartum
Secondary outcomes (6)
Consistent Contraceptive Usage
Measured by participant self-report on the Consistent Usage scale
Measured: 6-week postpartum and 12-week postpartum
Satisfaction with Agreed Contraceptive Method
Assessed via the validated Satisfaction of Agreed Method scale
Measured: 6-week postpartum and 12-week postpartum
Relationship Satisfaction
Measured using the Couple Satisfaction Index (CSI)
Measured: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Psychological Distress - Anxiety
Measured using PROMIS Anxiety short form
Measured: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Psychological Distress - Depression
Measured using PROMIS Depression short form
Measured: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Relationship Aggression
Measured using the Conflict Tactic Scale (CTS)
Measured: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start25 Nov 2025
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Interpregnancy IntervalsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214012
- Sponsor's protocol ID
- 5175
- Other IDs
- R21HD112736
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families
- ClinicalTrials.gov ID
- NCT07214012
- Acronym / sponsor ID
- 5175
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot trial is to examine the feasibility and acceptability of the Planning Together protocol
The hypothesis of this study are
- 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)
- The intervention will be acceptable, with >80% of participants reporting satisfaction with Planning Together.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Communication and Contraceptive Education Workbook (60-90 minutes) | Other | Other: Joint contraceptive and couple communication educationAsynchronous (during times convenient to the couple) (21-30 weeks gestation) Follow-up survey at the end of session |
| Couple Contraceptive Consultation (60-90 minutes) | Other | Other: Couple communication consultation with Interventionist to increase partner engagement and improve communicationIn-person at OBGYN appt or telehealth (couple preference). ~ 32 weeks gestation Follow-up survey at the end of session |
| Booster Check-ins (~30 minutes) | Other | Other: Check-ins to support continued partner support & communicationTelehealth/in-person (couple preference), ~6 weeks postpartum Follow-up survey at the end of sessions |
| Booster Check-ins (~30 minutes.) | Other | Other: Check-ins to support continued partner support & communicationTelehealth/in-person (couple preference), ~12 weeks postpartum Follow-up surveys at the end of session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- > 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
- 18 years of age and older
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint contraceptive and couple communication educationJoint 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 | Other | Communication and Contraceptive Education Workbook (60-90 minutes) |
| Couple communication consultation with Interventionist to increase partner engagement and improve communication1. 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 | Other | Couple Contraceptive Consultation (60-90 minutes) |
| Check-ins to support continued partner support & communication1. 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 | Other | Booster Check-ins (~30 minutes) |
| Check-ins to support continued partner support & communication1. 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 | Other | Booster Check-ins (~30 minutes.) |
Primary outcome
Feasibility of Study Procedures
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
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
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Measured by survey item: >80% of participants will report satisfaction with Planning Together using a Program Satisfaction questionnaire
Change in Contraceptive Knowledge
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Measured using the validated Contraceptive Knowledge tool
Change in Couple Communication Quality
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Assessed with the Communication Problems Questionnaire (CPQ)
Community Referral Utilization
Time frame: 32 weeks gestation to 12 weeks postpartum
Community Referral Utilization and Satisfaction Questionnaire Scale (4 items validated by Dr. Roberson with economically marginalized couples
6 secondary outcomes
Consistent Contraceptive Usage
Time frame: 6-week postpartum and 12-week postpartum
Satisfaction with Agreed Contraceptive Method
Time frame: 6-week postpartum and 12-week postpartum
Relationship Satisfaction
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Psychological Distress - Anxiety
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Psychological Distress - Depression
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Relationship Aggression
Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Tennessee Graduate School of Medicine
Knoxville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint contraceptive and couple communication education, Couple communication consultation with Interventionist to increase partner engagement and improve communication and Check-ins to support continued partner support & communication in people with Short Interpregnancy Intervals and Maternal Health Disparities, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study Procedures (time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.