Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07064837

Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Led by Johns Hopkins University · Updated on 2025-07-15

200

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

Baltimore Medical Systems Yard 56

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

T

Tania Caballero, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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