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

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ClinicalTrials.gov Identifier: NCT06014177
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : May 14, 2024
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jason E. Zucker, Columbia University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
STI Sexually Transmitted Infection (STI) Sexually Transmitted Disease (STD) Behavioral: STIckER Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study
Actual Study Start Date : September 12, 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. ED STI Testing Rate [ Time Frame: Day 0 ]
    Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.


Secondary Outcome Measures :
  1. Extragenital STI testing Rate [ Time Frame: Day 0 ]
    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.

  2. Genitourinary STI testing Rate [ Time Frame: Day 0 ]
    Percent of individuals with any gonorrhea or chlamydia genitourinary test performed in the ED on the day of their STIckER visit.

  3. STI Positivity Rate [ Time Frame: Day 0 ]
    Percent of individuals testing positive for gonorrhea or chlamydia at any site.

  4. Acceptability of Intervention Measure (AIM) Score [ Time Frame: At completion of all patient visits (within 6 months of enrollment) ]
    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.

  5. Intervention Appropriateness Measure (IAM) Score [ Time Frame: At completion of all patient visits (within 6 months of enrollment) ]
    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.

  6. Feasibility of Intervention Measure (FIM) Score [ Time Frame: At completion of all patient visits (within 6 months of enrollment) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014177


Contacts
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Contact: Jason Zucker, MD 212-305-7494 jz2700@cumc.columbia.edu
Contact: Lauren Chernick, MD lc2243@cumc.columbia.edu

Locations
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United States, New York
Children's Hospital of New York (CHONY) Recruiting
New York, New York, United States, 10032
Contact: Lauren Chernick, MD       lc2243@cumc.columbia.edu   
Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lauren Chernick, MD       lc2243@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jason Zucker, MD Columbia University
Principal Investigator: Lauren Chernick Columbia University
More Information
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Responsible Party: Jason E. Zucker, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT06014177    
Other Study ID Numbers: AAAU7485
5R21AI168958 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason E. Zucker, Columbia University:
Gonorrhea
Chlamydia
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Sexually Transmitted Diseases
Emergencies
 Disease Attributes
Pathologic Processes
Genital Diseases
Urogenital Diseases