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Completed

NCT Number: NCT06014177

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

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.

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Key information

Conditions

STI Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Disease (STD) Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Infection (STI) Urogenital Diseases

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of New York (CHONY), New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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."

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: STIckER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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