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NCT Number: NCT07214012

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37915, United States

Location status: Recruiting

Location contact

Patricia N.E. Roberson, PhD, Prinicipal Investigator

CONTACT

[email protected]

(865) 305-9230

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 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)

Exclusion criteria

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:

  • 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

Treatment and study plan

Joint contraceptive and couple communication education

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

  • 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 communication

Other
  • 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 & communication

Other
  • 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

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

Secondary outcomes

  1. Consistent Contraceptive Usage

    Time frame: 6-week postpartum and 12-week postpartum

    Measured by participant self-report on the Consistent Usage scale

  2. Satisfaction with Agreed Contraceptive Method

    Time frame: 6-week postpartum and 12-week postpartum

    Assessed via the validated Satisfaction of Agreed Method scale

  3. Relationship Satisfaction

    Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

    Measured using the Couple Satisfaction Index (CSI)

  4. Psychological Distress - Anxiety

    Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

    Measured using PROMIS Anxiety short form

  5. Psychological Distress - Depression

    Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

    Measured using PROMIS Depression short form

  6. Relationship Aggression

    Time frame: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum

    Measured using the Conflict Tactic Scale (CTS)

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.