Improvement of STI Detection in Adolescent Emergency Department Patients (SHS)

June 6, 2016 updated by: Monika Goyal, Children's National Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Decision Support Arm
Patients randomized to the intervention will complete a sexual health screen (SHS). The results of the SHS will provide decision support for STI testing by risk stratifying patients with screening recommendations to the clinician based on risk.
Behavioral: Sexual health screen (SHS)
Decision support for STI screening through a novel sexual health screen
NO_INTERVENTION: Usual Care Arm
Patients randomized to the usual care arm will complete the sexual health screen (SHS). However these results and the STI testing decision support will not be shared with the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
Time Frame: an expected average of 4-6 hours.
an expected average of 4-6 hours.

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Investigators

  • Principal Investigator: Monika Goyal, MD, MSCE, CNMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (ESTIMATE)

July 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00004169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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