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
• 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

• Sexually Transmitted Diseases
• Sexually Transmitted Infections

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