Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Not Applicable

Recruiting

• Conditions: Contraceptive Use

• Registration Number: NCT07064837
• Lead Sponsor: Johns Hopkins University

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

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-04
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of unmet maternal contraceptive need	At child's 12th month of life	Unmet need will be defined using a combination of widely used family planning and contraceptive use questions in a single survey. The same survey items will be administered to historical control group and then the cohort. There are three questions measuring contraceptive satisfaction, confidence in current contraceptive method use, and switching likelihood. These are 5 scaled answer options ranging from "very satisfied/confident to very dissatisfied/not confident at all" There are 2 possible definitions of unmet contraceptive need: 1) "Are you or your spouse or partner doing anything now to keep from getting pregnant?". 'No' and "Would you like to be using birth control right now to keep from getting pregnant? " 'Yes" and/or; 2) Low satisfaction and low confidence scores supports high likelihood of method switching and unmet need. Investigators will compare number of participants who meet unmet contraceptive need definition in cohort to number in historical control group.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure (FIM) score	Baseline and 12 months of implementation	The survey will include 4-item measures of feasibility. Score range is 4-20, higher scores indicate greater feasibility.
Acceptability of Intervention Measure (AIM)	Baseline and at 12 months of implementation	The survey will include 4-item measures of acceptability; total mean scores range from 1 - 5, higher scores indicate greater acceptability,
Intervention Appropriateness Measure (IAM)	Baseline and at 12 months of implementation	The survey will include 4-item measures of appropriateness. Total mean scores 1-5, higher score indicates greater appropriateness,
Number of clinic staff engaged with the intervention	Up to 15 months post intervention	As part of implementation evaluation investigators will conduct a focus group using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Trial Locations

Locations (1)

Baltimore Medical Systems Yard 56; 🇺🇸 Baltimore, Maryland, United States