Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06576193
Eligibility Criteria:
Inclusion Criteria:
Adolescent and Young Adult (AYA) \[EYP study participants\]
* Aged 14-21 years (inclusive) at Screening.
* Assigned female sex at birth.
* Currently pregnant or parenting their child who lives with them at least part-time.
* Able to speak and read English or Spanish.
* Able and willing to provide verbal informed consent for enrollment in the EYP study.
* Able and willing to provide adequate contact/locator information.
* Able and willing to complete protocol requirements, including completion of three study interviews over one year.
Study Facilitators (process evaluation participants)
* Aged 18 years or older.
* Trained and served as a facilitator of the SDYP intervention.
* Able to speak and read English.
* Able and willing to provide verbal informed consent.
Exclusion Criteria:
* Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
* Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
21 Years
Study:
NCT06576193
Study Brief:
Protocol Section:
NCT06576193