RecruitingNot Applicable

Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

United States200 participantsStarted 2024-10-15

Plain-language summary

The purpose of this study is to understand in what ways the pediatrician's office can support women's family planning by screening for contraceptive needs at each well child visit over the first 12 months of the child's life. Part one of the study will be working with families and clinic-based social needs navigators around where and how the screening process will be integrated into an existing pediatric workflow. Part two of the study will include (a) surveying mothers of 12-15 month olds about contraceptive use experience to get a baseline followed by (b) implementing the screening process into pediatrics and measuring how well the screener is able to identify unmet contraceptive needs and how people are or are not using the screening process. This will occur over approximately 12 months. Part (b) includes enrolling families who have a contraceptive need case and following the case in the child's medical record. At the end of the 12 month intervention the investigators will (c) invite some families to participant in an interview about the experience with the contraceptive need screener. Part three will be focus group feedback from clinicians and staff about the contraceptive need screening process. Part four will be key informant interviews with community stakeholders on the expansion of this screener.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

There are four study populations categorized in this study: * Staff of the Baltimore Medical Systems (BMS) medical practice, which includes clinicians (i.e. M.D., D.O., N.P.), medical assistants, nurses, receptionists; * Hopkins Community Connection Resource Advocates (i.e. staff) based at the BMS; * Community health care providers including clinicians, case managers, social workers, and nurses Eligible BMS patients comprised of the following subpopulations: 1. Latinas with a 12 month old child who is a BMS patient; 2. Latinas with an infant 0-1 month old who is a BMS patient. Eligibility criteria by population: Historical control group inclusion criteria are: * individuals who identify as Latina AND foreign-born, AND * communication preference is Spanish AND * 22 years or older (any parent 21 years or younger is almost always also one of the investigator's patients) AND * are the biological parent of a 12 month old child who is a BMS patient. Intervention cohort inclusion criteria are: * individuals who identify as Latina AND foreign-born, AND * communication preference is Spanish AND * 22 years or older AND * are the biological parent of a \< 1 month old who is a BMS patient. Participant inclusion criteria for Both: * BMS staff OR Hopkins Community Connection Advocate staff AND * age 18 years or older. Participant inclusion criteria for semi-structured interviews: * Member of intervention cohort group AND child * has completed 12 months of life AND * has complet…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of unmet maternal contraceptive need

Timeframe: At child's 12th month of life

Trial details

NCT IDNCT07064837

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Tania Caballero, MD

443-831-6561' tcaball1@jhmi.edu

View on ClinicalTrials.gov More Contraceptive Use trials