Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

NCT07064837 | Recruiting

• 2 other identifiers: IRB003897631K23HD110615-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive Use

Keywords

contraceptive need mothers; contraceptive need Latinas; pediatric clinic; screening; contraceptive choice; contraceptive need

Outcome Measures

Primary Outcomes (1)

• Proportion of unmet maternal contraceptive need

  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.

  At child's 12th month of life

Secondary Outcomes (4)

• Feasibility of Intervention Measure (FIM) score

  Baseline and 12 months of implementation

• Acceptability of Intervention Measure (AIM)

  Baseline and at 12 months of implementation

• Intervention Appropriateness Measure (IAM)

  Baseline and at 12 months of implementation

• Number of clinic staff engaged with the intervention

  Up to 15 months post intervention

Study Arms (2)

Contraceptive need screener 'Conecta'

EXPERIMENTAL

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: Conecta Familia; Other: Contraceptive need survey

Historical control group

PLACEBO COMPARATOR

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.

Other: Contraceptive need survey

Interventions

Conecta Familia 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 screener 'Conecta'

Contraceptive need survey OTHER

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

Contraceptive need screener 'Conecta'; Historical control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals who identify as Latina AND foreign-born, AND
• communication preference is Spanish AND
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Baltimore Medical Systems Yard 56

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

• Tania Caballero, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Caballero, MD

CONTACT

443-831-6561'; tcaball1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One arm will be exposed to the intervention (contraceptive need screener). Other individuals will be participating in other aspects of the study (interviews, focus groups, one time survey) to help contextualize the intervention but will not receive an actual intervention.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)