A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

STI Clinical Trial

— STIckER  

Official title:

A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014177
• Other study ID #: AAAU7485
• Secondary ID: 5R21AI168958
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Jason Zucker, MD
• Phone: 212-305-7494
• Email: jz2700[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually active young Emergency Department (ED) patients over six months in a pediatric and adult ED setting. The primary goal is to determine if sexually active young individuals who use STIckER are more likely to undergo STI testing. By developing an effective automated digital tool to increase STI testing, the investigators aim to improve evidence-based sexual health education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.

Description:

Improving sexually transmitted infection (STI) screening is vital to combat the STI epidemic, especially among adolescents and young adults (AYA) aged 15-24 years in the United States. Inadequate testing for STIs in different body areas contributes to disease transmission. Emergency Departments (EDs) treat a significant number of young individuals, many of whom come from economically disadvantaged backgrounds and minority communities. Previous research has shown inconsistent use of contraception in this population, and despite the willingness of ED providers to support sexual health interventions, time and resource limitations present implementation challenges. To address this issue, the investigators propose developing STIckER (STI ChecK in the ER), a digital patient decision aid for STI testing in the ED that promotes shared decision-making. STIckER involves three steps: (1) patients complete a nonjudgmental sexual health screening assessment by scanning a quick-response (QR) code, (2) educational modules facilitate shared decision-making (SDM) by connecting personalized STI risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital infographic aids the patient-provider discussion on STI testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

• AYA aged 14-24 years

• Sexually active within the past 6 months (per self-report)

• Ability to speak English

Exclusion criteria:

• Severe illness

• Cognitive impairment

• Inability to speak English

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Sexually Transmitted Disease (STD)
• Sexually Transmitted Diseases
• Sexually Transmitted Infection (STI)
• STI

Intervention

Behavioral:
• STIckER
STIckER is an interactive and personalized intervention based on the principles of SDM that has been designed with input from the AYA ED patients and providers. STIckER guides AYA patients through a series of steps, beginning with "scanning your STIckER." Participants complete risk assessments, SDM modules, and conclude with an anonymous final digital infographic that informs an SDM conversation with the medical provider. This decision aid seamlessly integrates into the ED workflow, recommending appropriate STI testing for high-risk individuals and using SDM concepts for those at intermediate risk.

Other:
• Control
After enrollment but before the start of their clinical visit, AYA participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, "If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor."

Locations

Country	Name	City	State
United States	Children's Hospital of New York (CHONY)	New York	New York
United States	Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ED STI Testing Rate	Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.	Day 0
Secondary	Extragenital STI testing Rate	Percent of individuals with any gonorrhea or chlamydia extra-genital (pharyngeal or rectal) test performed in the ED on the day of their STIckER visit.	Day 0
Secondary	Genitourinary STI testing Rate	Percent of individuals with any gonorrhea or chlamydia genitourinary test performed in the ED on the day of their STIckER visit.	Day 0
Secondary	STI Positivity Rate	Percent of individuals testing positive for gonorrhea or chlamydia at any site.	Day 0
Secondary	Acceptability of Intervention Measure (AIM) Score	Acceptability assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.	At completion of all patient visits (within 6 months of enrollment)
Secondary	Intervention Appropriateness Measure (IAM) Score	Appropriateness assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.	At completion of all patient visits (within 6 months of enrollment)
Secondary	Feasibility of Intervention Measure (FIM) Score	Feasibility assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome.	At completion of all patient visits (within 6 months of enrollment)