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

University of Tennessee Graduate School of Medicine

Status: Not yet enrolling

Conditions: Short Interpregnancy Intervals; Maternal Health Disparities

Treatments: Other: Couple communication consultation with Interventionist to increase partner engagement and improve communication; Other: Check-ins to support continued partner support & communication; Other: Joint contraceptive and couple communication education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214012

5175

R21HD112736 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Communication and Contraceptive Education Workbook (60-90 minutes)

Other group

Description:

Asynchronous (during times convenient to the couple) (21-30 weeks gestation) Follow-up survey at the end of session

Treatment:

Other: Joint contraceptive and couple communication education

Couple Contraceptive Consultation (60-90 minutes)

Other group

Description:

In-person at OBGYN appt or telehealth (couple preference). \~ 32 weeks gestation Follow-up survey at the end of session

Treatment:

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

Booster Check-ins (~30 minutes)

Other group

Description:

Telehealth/in-person (couple preference), \~6 weeks postpartum Follow-up survey at the end of sessions

Treatment:

Other: Check-ins to support continued partner support & communication

Other: Check-ins to support continued partner support & communication

Booster Check-ins (~30 minutes.)

Other group

Description:

Telehealth/in-person (couple preference), \~12 weeks postpartum Follow-up surveys at the end of session

Treatment:

Other: Check-ins to support continued partner support & communication

Other: Check-ins to support continued partner support & communication