NCT07064837

Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Conecta: A Stakeholder-informed Implementation Intervention for Contraceptive Screening, Referral, and Care Coordination.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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
OTHER	Contraceptive need survey	brief survey describing demographic information and contraceptive need, use, and experience

Timeline

• Start date: 2024-10-15
• Primary completion: 2028-04-01
• Completion: 2028-09-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States