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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Joint contraceptive and couple communication education
  Joint 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
• Другое Couple communication consultation with Interventionist to increase partner engagement and improve communication
  1. 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
• Другое Check-ins to support continued partner support & communication
  1. 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
• Другое Check-ins to support continued partner support & communication
  1. 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

Первичные конечные точки

• Feasibility of Study Procedures [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Acceptability of the Intervention [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Change in Contraceptive Knowledge [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Change in Couple Communication Quality [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Community Referral Utilization [Срок оценки: 32 weeks gestation to 12 weeks postpartum]

Вторичные конечные точки (6)

• Consistent Contraceptive Usage [Срок оценки: 6-week postpartum and 12-week postpartum]
• Satisfaction with Agreed Contraceptive Method [Срок оценки: 6-week postpartum and 12-week postpartum]
• Relationship Satisfaction [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Psychological Distress - Anxiety [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Psychological Distress - Depression [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]
• Relationship Aggression [Срок оценки: Baseline, 30 weeks gestation, 32 weeks gestation, 6-week postpartum, and 12-week postpartum]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Tennessee Graduate School of Medicine — Knoxville

Идентификаторы

NCT: NCT07214012 · 5175 · R21HD112736

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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