Trial Outcomes & Findings for Adolescent Sexually Transmitted Infection Screening in the Emergency Department (NCT NCT03715335)
NCT ID: NCT03715335
Last Updated: 2025-11-06
Results Overview
Our primary outcome measure is GC/CT detection rates per 1000 eligible patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98413 participants
Primary outcome timeframe
Through study completion, an average of 2 years
Results posted on
2025-11-06
Participant Flow
Patients were enrolled at 6 pediatric emergency departments between January 2021 and September 2023.
The initial 2-week ramp up period within each screening strategy phase was excluded from all analyses.
Unit of analysis: Site
Participant milestones
| Measure |
Site A
Sequence 1: 14 weeks of Baseline, 2 weeks of Ramp-Up, 26 weeks of Universally Offered STI Screening, 43 weeks of Targeted STI Screening
|
Site B
Sequence 2: 12 weeks of Baseline, 2 weeks of Ramp-Up, 26 weeks of Targeted STI Screening, 45 weeks of Universally Offered STI Screening
|
Site C
Sequence 3: 24 weeks of Baseline, 37 weeks of Universally Offered STI Screening, 2 weeks of Ramp-Up, 22 weeks of Targeted STI Screening
|
Site D
Sequence 4: 19 weeks Baseline, 2 weeks Ramp-up, 30 weeks Targeted STI Screening, 2 weeks Ramp-up, 32 weeks Universally Offered STI Screening
|
Site E
Sequence 5: 17 weeks Baseline, 2 weeks Ramp-up, 26 weeks Universally Offered STI Screening, 2 weeks Ramp-up, 38 weeks Targeted STI Screening
|
Site F
Sequence 6: 22 weeks Baseline, 2 weeks Ramp-up, 31 weeks Targeted STI Screening, 30 weeks Universally Offered STI Screening
|
|---|---|---|---|---|---|---|
|
Overall Study Total
STARTED
|
24765 1
|
18080 1
|
10969 1
|
23333 1
|
12748 1
|
13144 1
|
|
Overall Study Total
COMPLETED
|
23730 1
|
17200 1
|
10488 1
|
22294 1
|
12153 1
|
12548 1
|
|
Overall Study Total
NOT COMPLETED
|
1035 0
|
880 0
|
481 0
|
1039 0
|
595 0
|
596 0
|
|
Baseline
STARTED
|
3110 1
|
1999 1
|
2753 1
|
5291 1
|
2164 1
|
3316 1
|
|
Baseline
COMPLETED
|
3110 1
|
1999 1
|
2753 1
|
5291 1
|
2164 1
|
3316 1
|
|
Baseline
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Ramp-up 1
STARTED
|
544 1
|
439 1
|
242 1
|
499 1
|
311 1
|
251 1
|
|
Ramp-up 1
COMPLETED
|
544 1
|
439 1
|
242 1
|
499 1
|
311 1
|
251 1
|
|
Ramp-up 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Screening Intervention 1
STARTED
|
7732 1
|
5815 1
|
4907 1
|
9252 1
|
4663 1
|
4973 1
|
|
Screening Intervention 1
COMPLETED
|
7732 1
|
5815 1
|
4907 1
|
9252 1
|
4663 1
|
4973 1
|
|
Screening Intervention 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Ramp-up 2
STARTED
|
491 1
|
441 1
|
239 1
|
540 1
|
284 1
|
345 1
|
|
Ramp-up 2
COMPLETED
|
491 1
|
441 1
|
239 1
|
540 1
|
284 1
|
345 1
|
|
Ramp-up 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Screening Intervention 2
STARTED
|
12888 1
|
9386 1
|
2828 1
|
7751 1
|
5326 1
|
4259 1
|
|
Screening Intervention 2
COMPLETED
|
12888 1
|
9386 1
|
2828 1
|
7751 1
|
5326 1
|
4259 1
|
|
Screening Intervention 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adolescent Sexually Transmitted Infection Screening in the Emergency Department
Baseline characteristics by cohort
| Measure |
Targeted STI Screening
n=41082 Participants
Data from the Sexual Health Screen (SHS) will be integrated into the Electronic Health Record (EHR) and will provide Clinical Decision Support (CDS) for GC/CT testing based on SHS-calculated STI risk. Patients will be classified as at high risk for STIs, at risk or low risk if they deny any history of sexual activity. When patients classify as at high risk, clinicians will receive CDS that STI testing is "highly recommended"; when they care for patients who classify as at risk, they will receive CDS that STI testing is "recommended"; when caring for patients who classify as at low risk, they will receive CDS that STI testing "is not necessary at this time." If the clinician chooses to follow the recommendation for screening based on patient's risk assessment, and the patient consents to testing on the tablet device, urine GC/CT testing will be performed.
|
Baseline
n=18633 Participants
Current STI screening rates.
|
Universally Offered STI Screening
n=38698 Participants
During the universally offered screening intervention, STI screening will be offered to all eligible adolescents, regardless of risk. All eligible patients will also complete the SHS, will be informed of the CDC GC/CT testing recommendations and then be given the option to decline STI testing using the tablet device. During this phase, the SHS results will not be available to the clinician. STI testing recommendations will be based only on the patient's decision to undergo GC/CT testing. Like the process followed in the targeted screening phase, if the clinician follows the CDS that informs the clinician that the patient agreed to GC/CT screening and consequently orders testing, urine GC/CT testing will be performed.
|
Total
n=98413 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Number of Participants ยท < 16 years of age
|
11350 Participants
n=49 Participants
|
5225 Participants
n=50 Participants
|
10774 Participants
n=50 Participants
|
27349 Participants
n=50 Participants
|
|
Age, Customized
Number of Participants ยท 16 - <18 years of age
|
21484 Participants
n=49 Participants
|
9573 Participants
n=50 Participants
|
19870 Participants
n=50 Participants
|
50927 Participants
n=50 Participants
|
|
Age, Customized
Number of Participants ยท 18 - < 22 years of age
|
8248 Participants
n=49 Participants
|
3835 Participants
n=50 Participants
|
8054 Participants
n=50 Participants
|
20137 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9505 Participants
n=49 Participants
|
4750 Participants
n=50 Participants
|
11368 Participants
n=50 Participants
|
25623 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27472 Participants
n=49 Participants
|
12368 Participants
n=50 Participants
|
22663 Participants
n=50 Participants
|
62503 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4105 Participants
n=49 Participants
|
1515 Participants
n=50 Participants
|
4667 Participants
n=50 Participants
|
10287 Participants
n=50 Participants
|
|
Insurance Status
Government
|
21959 Participants
n=49 Participants
|
9353 Participants
n=50 Participants
|
22052 Participants
n=50 Participants
|
53364 Participants
n=50 Participants
|
|
Insurance Status
Commercial
|
17500 Participants
n=49 Participants
|
8409 Participants
n=50 Participants
|
14165 Participants
n=50 Participants
|
40074 Participants
n=50 Participants
|
|
Insurance Status
Other
|
1581 Participants
n=49 Participants
|
867 Participants
n=50 Participants
|
2454 Participants
n=50 Participants
|
4902 Participants
n=50 Participants
|
|
Insurance Status
Unknown or Missing
|
42 Participants
n=49 Participants
|
4 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
73 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Female
|
23510 Participants
n=49 Participants
|
11037 Participants
n=50 Participants
|
22466 Participants
n=50 Participants
|
57013 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Male
|
17532 Participants
n=49 Participants
|
7568 Participants
n=50 Participants
|
16155 Participants
n=50 Participants
|
41255 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Other
|
27 Participants
n=49 Participants
|
20 Participants
n=50 Participants
|
56 Participants
n=50 Participants
|
103 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Unknown/Missing
|
13 Participants
n=49 Participants
|
8 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
42 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black
|
13536 Participants
n=49 Participants
|
5606 Participants
n=50 Participants
|
11708 Participants
n=50 Participants
|
30850 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
19235 Participants
n=49 Participants
|
9462 Participants
n=50 Participants
|
15814 Participants
n=50 Participants
|
44511 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
98 Participants
n=49 Participants
|
44 Participants
n=50 Participants
|
124 Participants
n=50 Participants
|
266 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1038 Participants
n=49 Participants
|
414 Participants
n=50 Participants
|
953 Participants
n=50 Participants
|
2405 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
714 Participants
n=49 Participants
|
208 Participants
n=50 Participants
|
677 Participants
n=50 Participants
|
1599 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other
|
5564 Participants
n=49 Participants
|
2522 Participants
n=50 Participants
|
7026 Participants
n=50 Participants
|
15112 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Missing/Unknown
|
897 Participants
n=49 Participants
|
377 Participants
n=50 Participants
|
2396 Participants
n=50 Participants
|
3670 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 2 yearsPopulation: Patients tested for STI
Our primary outcome measure is GC/CT detection rates per 1000 eligible patients.
Outcome measures
| Measure |
Baseline
n=1422 Participants
Current STI screening rates.
|
Targeted STI Screening
n=3023 Participants
Data from the Sexual Health Screen (SHS) will be integrated into the Electronic Health Record (EHR) and will provide Clinical Decision Support (CDS) for GC/CT testing based on SHS-calculated STI risk. Patients will be classified as at high risk for STIs, at risk or low risk if they deny any history of sexual activity. When patients classify as at high risk, clinicians will receive CDS that STI testing is "highly recommended"; when they care for patients who classify as at risk, they will receive CDS that STI testing is "recommended"; when caring for patients who classify as at low risk, they will receive CDS that STI testing "is not necessary at this time." If the clinician chooses to follow the recommendation for screening based on patient's risk assessment, and the patient consents to testing on the tablet device, urine GC/CT testing will be performed.
Targeted STI Screening: GC/CT screening will be offered to those who screen at risk or at high risk for STIs.
|
Universally Offered STI Screening
n=2822 Participants
During the universally offered screening intervention, STI screening will be offered to all eligible adolescents, regardless of risk. All eligible patients will also complete the SHS, will be informed of the CDC GC/CT testing recommendations and then be given the option to decline STI testing using the tablet device. During this phase, the SHS results will not be available to the clinician. STI testing recommendations will be based only on the patient's decision to undergo GC/CT testing. Like the process followed in the targeted screening phase, if the clinician follows the CDS that informs the clinician that the patient agreed to GC/CT screening and consequently orders testing, urine GC/CT testing will be performed.
Universally Offered STI Screening: GC/CT screening will be offered to all patients who meet the age eligibility criteria.
|
|---|---|---|---|
|
GC/CT Detection Rates
|
15.2 No. of patients with positive GC/CT
Interval 12.7 to 17.9
|
12.1 No. of patients with positive GC/CT
Interval 9.5 to 14.8
|
11 No. of patients with positive GC/CT
Interval 9.3 to 13.6
|
Adverse Events
Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Targeted STI Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Universally Offered STI Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Reed
Cincinnati Children's Hospital Medical Center
Phone: (513) 636-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place