Utilizing Pediatric Primary Care Connections to Advance Reproductive Health
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT07064837
- Status
- Recruiting
Conditions
- Contraceptive Use
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Conecta Familia — OTHERThe 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 — OTHERbrief survey describing demographic information and contraceptive need, use, and experience
Study Details
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.
Key Dates
- Start date
- Oct 15, 2024
- Status verified
- Jul 2025
- Primary completion
- Apr 30, 2028
- Completion
- Sep 1, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SCREENING
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 groupOne 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.
Primary Outcome Measure
Proportion of unmet maternal contraceptive need [ Time Frame: At child's 12th month of life ]
Central Contacts
- Tania Caballero, MD443-831-6561'
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baltimore Medical Systems Yard 56 | Baltimore | Maryland | 21224 | - |