Sexually Transmitted InfectionsSHSNCT02509572
Improvement of STI Detection in Adolescent Emergency Department Patients
A study testing Sexual health screen (SHS) in people with Sexually Transmitted Infections, run by Children's National Research Institute at 1 site in United States.
Trial summary
The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Sexually Transmitted Infections
- What is being tested?
- Sexual health screen (SHS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 14-19 presenting to the emergency department.
Who cannot join
- history of developmental delay,
- medical instability,
- altered mental status,
- unable to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.
Read the detailed description
The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.
- Conditions
- Sexually Transmitted Infections
- Being tested
- Sexual health screen (SHS)
- 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.
Sexual health screen (SHS)Behavioural
Decision support for STI screening through a novel sexual health screen
| Study group | Role | What they receive |
|---|---|---|
| Decision Support Arm | Experimental | Patients randomized to the intervention will complete a sexual health screen (SHS). The results of the SHS will provide decision support for STI testing by risk stratifying patients with screening recommendations to the clinician based on risk. Receives: Behavioral: Sexual health screen (SHS) |
| Usual Care Arm | No intervention | Patients randomized to the usual care arm will complete the sexual health screen (SHS). However these results and the STI testing decision support will not be shared with the clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
Measured: an expected average of 4-6 hours.
Secondary outcomes (1)
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (actual)
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
- Investigators
- Monika Goyal, MD, MSCE, Principal investigator, CNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509572
- Sponsor's protocol ID
- 00004169
- Acronym
- SHS
- Status last verified
- Jun 2016
- First submitted
- 21 Jul 2015
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goyal MK, Fein JA, Badolato GM, Shea JA, Trent ME, Teach SJ, Zaoutis TE, Chamberlain JM. A Computerized Sexual Health Survey Improves Testing for Sexually Transmitted Infection in a Pediatric Emergency Department. J Pediatr. 2017 Apr;183:147-152.e1. doi: 10.1016/j.jpeds.2016.12.045. Epub 2017 Jan 10.
PubMed 28081888
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of STI Detection in Adolescent Emergency Department Patients
- ClinicalTrials.gov ID
- NCT02509572
- Acronym / sponsor ID
- SHS / 00004169
- Conditions
- Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jul 2015 (estimated)
- 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.
The goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (STI) in adolescent emergency department (ED) patients at high risk for STIs.
Detailed description
The investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ED) through the use of an audio-computer assisted self-interview (ACASI). This information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (STI) screening in the ED for adolescents. This randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased STI screening for patients who report high risk sexual activity. Secondary outcomes include evaluation of whether the clinical decision support results in increased STI detection, and identifying factors associated with adapting the clinical decision support.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Support Arm | Experimental | Behavioral: Sexual health screen (SHS)Patients randomized to the intervention will complete a sexual health screen (SHS). The results of the SHS will provide decision support for STI testing by risk stratifying patients with screening recommendations to the clinician based on risk. |
| Usual Care Arm | No intervention | –Patients randomized to the usual care arm will complete the sexual health screen (SHS). However these results and the STI testing decision support will not be shared with the clinician. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Aged 14-19 presenting to the emergency department.
Key exclusion criteria (4 listed)
- history of developmental delay,
- medical instability,
- altered mental status,
- unable to understand English
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 |
|---|---|---|
| Sexual health screen (SHS)Decision support for STI screening through a novel sexual health screen | Behavioural | Decision Support Arm |
Primary outcome
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group.
Time frame: an expected average of 4-6 hours.
1 secondary outcome
The proportion of adolescents who test positive for an STI in the intervention group in comparison to the usual care group.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Derived from this study: PubMed 28081888Goyal MK, Fein JA, Badolato GM, Shea JA, Trent ME, Teach SJ, Zaoutis TE, Chamberlain JM. A Computerized Sexual Health Survey Improves Testing for Sexually Transmitted Infection in a Pediatric Emergency Department. J Pediatr. 2017 Apr;183:147-152.e1. doi: 10.1016/j.jpeds.2016.12.045. Epub 2017 Jan 10.
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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. This study is not recruiting at the moment.
Monika Goyal, MD, MSCE principal investigator
CNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual health screen (SHS) in people with Sexually Transmitted Infections, 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 4 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: finished, as of the sponsor's last update on 8 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with difference in frequency of STI testing between the ACASI-SHS group compared to the usual care group. (time frame: an expected average of 4-6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509572, which also lists 1 linked publication.
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 8 Jun 2016.