An interventional study of STIckER and Control in STI, Sexually Transmitted Infection (STI) and Sexually Transmitted Disease (STD), sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
435 studies on the registry are indexed under Sexually Transmitted Diseases; 73 are open to participants now.
This study's enrollment of 184 is below the median of 460 across 356 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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, 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.
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."
ED STI Testing Rate
Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit.
Time frame: Day 0
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.
Time frame: 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.
Time frame: Day 0
STI Positivity Rate
Percent of individuals testing positive for gonorrhea or chlamydia at any site.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At completion of all patient visits (within 6 months of enrollment)
Plan to share: No
Ran from Sep 2023 to primary completion in May 2024, 8 months.
Of 149 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 159 studies reached it within 29 months; a quarter within 15 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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