Sexually Transmitted Diseases Clinical Trial
Official title:
Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial
NCT number | NCT03341975 |
Other study ID # | 17010079 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2017 |
Est. completion date | May 1, 2020 |
Verified date | February 2021 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | May 1, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Uptake of 1 or More Health Services | Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral. | Index visit |
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