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NCT02509572 Clinical Trial

Improvement of STI Detection in Adolescent Emergency Department Patients

Sexually Transmitted Infections Clinical Trial

— SHS  

Official title:
Improvement of STI Detection in Adolescent Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02509572
Other study ID # 00004169
Secondary ID
Status Completed
Phase N/A
First received July 21, 2015
Last updated June 6, 2016
Start date October 2014
Est. completion date June 2016

Study information
Verified date June 2016
Source Children's Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.

Description:

The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.

Recruitment information / eligibility
Status Completed
Enrollment 720
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- Aged 14-19 presenting to the emergency department.

Exclusion Criteria:

- history of developmental delay,

- medical instability,

- altered mental status,

- unable to understand English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sexual health screen (SHS)
Decision support for STI screening through a novel sexual health screen

Locations
Country Name City State
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group. an expected average of 4-6 hours. No
Secondary The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group. Baseline No
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