N/A
N=91
Enhanced SexHealth Intervention to Improve Adolescent Outcomes
Sexually Transmitted Diseases · Reproductive Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03341975 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Uptake of 1 or More Health Services — 43; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SexHealth (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Uptake of 1 or More Health Services |
43; 33 | — |
Summary
This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.
Eligibility Criteria
Inclusion Criteria
- Aged 14-19 years old
- Reside within 30 minutes travel time
- Report previous sexual activity
Exclusion Criteria
- Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
- Subjects in police custody
- Subjects seeking care due to sexual assault or psychiatric emergency
- Subjects who do not speak English
- Subjects who are patients under the clinical care of a study investigator working in the ED
Data sourced from ClinicalTrials.gov (NCT03341975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.