NCT07064837 · Johns Hopkins University
Utilizing Pediatric Primary Care Connections to Advance Reproductive Health
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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
OTHER
Contraceptive need survey
brief survey describing demographic information and contraceptive need, use, and experience
Primary outcome measures
Proportion of unmet maternal contraceptive need
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Baltimore, Maryland
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2025 · Source of record for eligibility and locations