Clinical trial NCT06014177: A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study
Official title: A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STI
Sexually Transmitted Infection (STI)
Sexually Transmitted Disease (STD)
Keywords: Gonorrhea
Chlamydia
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-08-28
Enrollment: 184
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: ED STI Testing Rate
timeFrame: Day 0
Secondary outcomes:
measure: Extragenital STI testing Rate
timeFrame: Day 0
measure: Genitourinary STI testing Rate
timeFrame: Day 0
measure: STI Positivity Rate
timeFrame: Day 0
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: At completion of all patient visits (within 6 months of enrollment)
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: At completion of all patient visits (within 6 months of enrollment)
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: At completion of all patient visits (within 6 months of enrollment)
Other outcomes:
Locations:
city: New York
country: United States
facility: Children's Hospital of New York (CHONY)
state: New York
city: New York
country: United States
facility: Milstein Hospital at NewYork-Presbyterian Hospital /Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jason Zucker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Lauren Chernick
role: PRINCIPAL_INVESTIGATOR
References: