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

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.

Study Overview

• Status: Recruiting
• Conditions: STI; Sexually Transmitted Disease (STD); Sexually Transmitted Infection (STI)
• Intervention / Treatment: Other: Control; Behavioral: STIckER

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Zucker, MD; Phone Number: 212-305-7494; Email: jz2700@cumc.columbia.edu
• Study Contact Backup: Name: Lauren Chernick, MD; Email: lc2243@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Children's Hospital of New York (CHONY)
      • Contact: Lauren Chernick, MD; Email: lc2243@cumc.columbia.edu
    • New York, New York, United States, 10032
      • Recruiting
      • Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center
      • Contact: Lauren Chernick, MD; Email: lc2243@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; After enrollment but before the start of their clinical visit, 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." At the end of the visit, the participant will complete the "Patient Control Exit Survey" while the provider will complete the "Provider Control Exit Survey". These participants will not receive STIckER training.	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."
Experimental: STIckER; After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing. At the end of the visit, the participant will complete the "Patient Intervention Exit Survey" while the provider will complete the "Provider Intervention Exit Survey.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
STI Positivity Rate	Percent of individuals testing positive for gonorrhea or chlamydia at any site.	Day 0
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)
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)
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)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Jason Zucker, MD, Columbia University; Principal Investigator: Lauren Chernick, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chlamydia; Gonorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Urogenital Diseases; Genital Diseases; Emergencies; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: AAAU7485; 5R21AI168958 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No