Recruiting

Contraceptive Screening

Sponsor:

Johns Hopkins University

Code:

NCT07064837

Conditions

Contraceptive Use

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Conecta Familia

Contraceptive need survey

Study Details

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

Study ID

NCT07064837

Start date

Oct 15, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Contraceptive need screener 'Conecta'

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

placebo comparator: Historical control group

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.

Interventions

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

Contraceptive need survey

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

Primary outcome measure

  • Proportion of unmet maternal contraceptive need [ Time Frame: At child's 12th month of life ]

Central Contacts and Locations

Central contacts

Tania Caballero, MD

443-831-6561'tcaball1@jhmi.edu

Locations

Baltimore Medical Systems Yard 56

Recruiting

Baltimore, Maryland, United States, 21224

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-20.