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

Not Applicable

Not yet recruiting

• Conditions: Short Interpregnancy Intervals; Maternal Health Disparities

• Registration Number: NCT07214012
• Lead Sponsor: University of Tennessee Graduate School of Medicine

Brief 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. 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.

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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2025-10-15
• Primary Completion: 2026-10-14
• Study Completion: 2026-10-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Study Procedures	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	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	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	Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum	Assessed with the Communication Problems Questionnaire (CPQ)
Community Referral Utilization	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 Outcome Measures

Name	Time	Method
Consistent Contraceptive Usage	6-week postpartum and 12-week postpartum	Measured by participant self-report on the Consistent Usage scale
Satisfaction with Agreed Contraceptive Method	6-week postpartum and 12-week postpartum	Assessed via the validated Satisfaction of Agreed Method scale
Relationship Satisfaction	Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum	Measured using the Couple Satisfaction Index (CSI)
Psychological Distress - Anxiety	Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum	Measured using PROMIS Anxiety short form
Psychological Distress - Depression	Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum	Measured using PROMIS Depression short form
Relationship Aggression	Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum	Measured using the Conflict Tactic Scale (CTS)

Trial Locations

Locations (1)

University of Tennessee Graduate School of Medicine; 🇺🇸 Knoxville, Tennessee, United States