NCT07064837 Utilizing Pediatric Primary Care Connections to Advance Reproductive Health
| NCT ID | NCT07064837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Contraceptive Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-15 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 completed contraceptive need survey. Participant inclusion criteria for key informant interviews: * staff member from one of 5 local health care clinics including Baltimore City Department of Health, Planned Parenthood, Women, Infants, and Children, and two federally qualified health centers AND * direct interaction with Spanish speaking individuals AND * age 18 years or older. Exclusion Criteria: Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment
Contact & Investigator
Tania Caballero, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07064837 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Contraceptive Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07064837 currently recruiting?
Yes, NCT07064837 is actively recruiting participants. Contact the research team at tcaball1@jhmi.edu for enrollment information.
Where is the NCT07064837 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07064837 clinical trial?
NCT07064837 is sponsored by Johns Hopkins University. The principal investigator is Tania Caballero, MD at Johns Hopkins University. The trial plans to enroll 200 participants.