Pediatric-based contraceptive screening and care coordination for Latina mothers

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

This project will test a Spanish-language screening and care-coordination program in pediatric clinics to see if it helps Latina immigrant mothers meet their contraceptive needs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07064837 on ClinicalTrials.gov

What this trial studies

The team will develop and refine Conecta, a Spanish-language contraceptive needs screener and care-coordination workflow adapted to existing pediatric social needs navigation. Stakeholders including clinic staff and families will co-design how the screener fits into well-child visits during the first year of life. Investigators will collect baseline survey data from mothers of 12–15 month olds, implement the screening across pediatric visits for about 12 months, and enroll families identified with contraceptive needs to follow outcomes in the child’s record. The pilot uses a Hybrid Type 1 implementation-effectiveness approach to measure how well the screener identifies unmet need and how the workflow is used.

Who should consider this trial

Good fit: Ideal participants are Spanish-preferring, foreign-born Latina mothers who receive pediatric care at Baltimore Medical Systems and have an infant within the enrollment age windows.

Not a fit: People who are not Spanish-preferring, not Latina, not patients at the Baltimore clinic, or who already have their contraceptive needs met are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Conecta could reduce unmet contraceptive need among Spanish-preferring Latina immigrant mothers by connecting them to care through pediatric visits.

How similar studies have performed: Embedding reproductive health screening into pediatric settings has shown feasibility in small pilots, but Spanish-language, pediatric-based interventions focused on Latina immigrants remain relatively novel and under-tested.

Eligibility criteria

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

Where this trial is running

Baltimore, Maryland

• Baltimore Medical Systems Yard 56 — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Tania Caballero, MD — Johns Hopkins University
• Study coordinator: Tania Caballero, MD

Conditions Contraceptive Use; contraceptive need mothers; contraceptive need Latinas; pediatric clinic; screening; contraceptive choice; contraceptive need