Pediatric-based contraceptive screening and care coordination for Latina mothers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tcaball1@jhmi.edu
• Phone: 443-831-6561'

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.