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

NCT06014177 | Completed DMC

• 2 other identifiers: AAAU74855R21AI168958
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

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.

Conditions

STI; Sexually Transmitted Infection (STI); Sexually Transmitted Disease (STD)

Keywords

Gonorrhea; Chlamydia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Extragenital STI testing Rate

  Day 0

• Genitourinary STI testing Rate

  Day 0

• STI Positivity Rate

  Day 0

• Acceptability of Intervention Measure (AIM) Score

  At completion of all patient visits (within 6 months of enrollment)

• Intervention Appropriateness Measure (IAM) Score

  At completion of all patient visits (within 6 months of enrollment)

Study Arms (2)

Control

OTHER

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

STIckER

EXPERIMENTAL

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

Interventions

STIckER BEHAVIORAL

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.

STIckER

Control OTHER

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."

Control

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• AYA aged 14-24 years
• Sexually active within the past 6 months (per self-report)
• Ability to speak English

You may not qualify if:

• Severe illness
• Cognitive impairment
• Inability to speak English

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Children's Hospital of New York (CHONY)

New York, New York, 10032, United States

Location

Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections

Study Officials

• Jason Zucker, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Lauren Chernick

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: September 12, 2023
• Primary Completion: May 28, 2024
• Study Completion: June 13, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)