Sexually Transmitted DiseasesNCT04372875
Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial
A study testing SHS-derived CDS in people with Sexually Transmitted Diseases, run by Children's National Research Institute at 1 site in United States.
Trial summary
We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- SHS-derived CDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents aged 15-21 years seeking care in the emergency department
Who cannot join
- Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Monika Goyal, MD, 12024762869, mgoyal@cnmc.org
About this study
Official title: Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- SHS-derived CDS
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHS-derived CDSBehavioural
This intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI.
| Study group | Role | What they receive |
|---|---|---|
| SHS-derived CDS | Experimental | All adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial. Receives: Behavioral: SHS-derived CDS |
| Usual care | No intervention | All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates
Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.
Measured: 3-7 days after emergency department (ED) visit
Secondary outcomes (1)
STI rates by race/ethnicity
Change in STI rates by race/ethnicity
Measured: 3-7 days after ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start8 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Goyal, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372875
- Sponsor's protocol ID
- Pro00014276
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
- ClinicalTrials.gov ID
- NCT04372875
- Acronym / sponsor ID
- Pro00014276
- Conditions
- Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18,500 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHS-derived CDS | Experimental | Behavioral: SHS-derived CDSAll adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial. |
| Usual care | No intervention | –All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents aged 15-21 years seeking care in the emergency department
Key exclusion criteria (1 listed)
- Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHS-derived CDSThis intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI. | Behavioural | SHS-derived CDS |
Primary outcome
Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates
Time frame: 3-7 days after emergency department (ED) visit
Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.
1 secondary outcome
STI rates by race/ethnicity
Time frame: 3-7 days after ED visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHS-derived CDS in people with Sexually Transmitted Diseases, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meleah Boyle (2024765388, mdboyle@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates (time frame: 3-7 days after emergency department (ED) visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.