NCT07214012 · University of Tennessee Graduate School of Medicine
Planning Together: A Couple-based, Multi-level Prenatal Contraceptive Education Program for Economically Marginalized Families
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Knoxville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations