Sexually Transmitted DiseasesNCT03341975
Enhanced SexHealth Intervention to Improve Adolescent Outcomes
A study testing SexHealth in people with Sexually Transmitted Diseases and Reproductive Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Reproductive Behavior
- What is being tested?
- SexHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 14-19 years old
- Reside within 30 minutes travel time
- Report previous sexual activity
Who cannot join
- Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
- Subjects in police custody
- Subjects seeking care due to sexual assault or psychiatric emergency
- Subjects who do not speak English
- Subjects who are patients under the clinical care of a study investigator working in the ED
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial
This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.
Read the detailed description
In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.
- Being tested
- SexHealth
- Medical subject headings
- Sexually Transmitted Diseases, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SexHealthBehavioural
To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study. Receives: Behavioral: SexHealth |
| Control | No intervention | They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Uptake of 1 or More Health Services
Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral.
Measured: Index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Miller, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341975
- Sponsor's protocol ID
- 17010079
- Status last verified
- Feb 2021
- First submitted
- 6 Nov 2017
- Last updated
- 25 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller MK, Catley D, Adams A, Staggs VS, Dowd MD, Stancil SL, Miller E, Satterwhite CL, Bauermeister J, Goggin K. Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department. J Pediatr. 2021 Oct;237:250-257.e2. doi: 10.1016/j.jpeds.2021.06.007. Epub 2021 Jun 16.
PubMed 34144031
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03341975
- Acronym / sponsor ID
- 17010079
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.
Detailed description
In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SexHealthThey will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered testing (for pregnancy, gonorrhea/chlamydia, and /or HIV), hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study. |
| Control | No intervention | –They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 14-19 years old
- Reside within 30 minutes travel time
- Report previous sexual activity
Key exclusion criteria (5 listed)
- Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
- Subjects in police custody
- Subjects seeking care due to sexual assault or psychiatric emergency
- Subjects who do not speak English
- Subjects who are patients under the clinical care of a study investigator working in the ED
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 |
|---|---|---|
| SexHealthTo enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care. | Behavioural | Intervention |
Primary outcome
Number of Participants With Uptake of 1 or More Health Services
Time frame: Index visit
Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34144031Miller MK, Catley D, Adams A, Staggs VS, Dowd MD, Stancil SL, Miller E, Satterwhite CL, Bauermeister J, Goggin K. Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department. J Pediatr. 2021 Oct;237:250-257.e2. doi: 10.1016/j.jpeds.2021.06.007. Epub 2021 Jun 16.
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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.
Melissa Miller, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SexHealth in people with Sexually Transmitted Diseases and Reproductive Behavior, run by Children's Mercy Hospital Kansas City 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 3 inclusion and 5 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 25 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Uptake of 1 or More Health Services (time frame: Index visit). 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 NCT03341975, 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 25 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.