Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

NCT ID: NCT07064837

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2028-09-01

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.

Detailed Description

The investigators propose to design and test a Spanish-language maternal contraceptive needs screening and care coordination intervention within primary care pediatrics called Conecta. The investigator's goal is to determine if this intervention can reduce unmet contraceptive need among Latina immigrant mothers. The aims of this study are:

Aim 1: To refine Conecta, a stakeholder-informed Spanish language contraceptive needs screening and care coordination intervention for implementation with existing pediatric social needs navigation, Hopkins Community Connection (HCC). The investigators will translate workflow observations into process maps and present and discuss the process maps with stakeholders who will visually assess the stakeholder's role and interaction in the workflow. Stakeholders will focus feedback on specific, practical ways that contraceptive needs screening and care coordination support would be valuable. This feedback will help the investigators build Conecta from the existing scaffolding of the HCC structure.

Aim 2: To conduct a Hybrid Type 1 implementation-effectiveness pilot of Conecta and evaluate 1) Conecta's effectiveness in reducing unmet contraceptive need, and 2) Conecta's

Conditions

Contraceptive Use

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Contraceptive need screener 'Conecta'

The Conecta intervention is a Spanish language contraceptive need screening and referral process that includes a screener and referral to social needs navigation bundled with developmental screener in 0-12 month old pediatric well visit for written completion by the mother of the patient

Group Type: EXPERIMENTAL

Conecta Familia

Intervention Type: OTHER

The Conecta intervention is a Spanish language contraceptive need screening and referral process that includes a screener and referral to social needs navigation bundled with developmental screener in 0-12 month old pediatric well visit for written completion by the mother of the patient

Contraceptive need survey

Intervention Type: OTHER

brief survey describing demographic information and contraceptive need, use, and experience

Historical control group

One time survey of contraceptive use and need experience among mothers of 12-15 month olds. Recruitment will occur prior to intervention with a sample of individuals who will be comparable to those who will participate in intervention.

Group Type: PLACEBO_COMPARATOR

Contraceptive need survey

Intervention Type: OTHER

brief survey describing demographic information and contraceptive need, use, and experience

Interventions

Conecta Familia

The Conecta intervention is a Spanish language contraceptive need screening and referral process that includes a screener and referral to social needs navigation bundled with developmental screener in 0-12 month old pediatric well visit for written completion by the mother of the patient

Intervention Type: OTHER

Contraceptive need survey

brief survey describing demographic information and contraceptive need, use, and experience

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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:

• 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.

• 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.

• BMS staff OR Hopkins Community Connection Advocate staff AND
• age 18 years or older.

• Member of intervention cohort group AND child
• has completed 12 months of life AND
• has completed contraceptive need survey.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania Caballero, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Baltimore Medical Systems Yard 56

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tania Caballero, MD

Role: CONTACT

tcaball1@jhmi.edu

443-831-6561'

Other Identifiers

1K23HD110615-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00389763

Identifier Type: -

Identifier Source: org_study_id