Sexually Transmitted InfectionsNCT01938053
Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
A study testing Call when test results are ready, Text message when test results are ready and Call and text message when test results are ready in people with Sexually Transmitted Infections, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The primary goal of this project is to improve the process for contacting patients that test positive for a sexually transmitted infection (STI) in the emergency department by using text messaging. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Sexually Transmitted Infections
- What is being tested?
- Call when test results are ready, Text message when test results are ready and Call and text message when test results are ready
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14 to 21 years old
- Seen in the emergency department at Cincinnati Children's Hospital Medical Center
- Test positive for an STI
Who cannot join
- Seen for a psychiatric evaluation
- Seen for sexual assault or abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The primary goal of this project is to improve the process for contacting patients that test positive for a sexually transmitted infection (STI) in the emergency department by using text messaging. We believe patients that are contacted by both a phone call and a text message will be reached more often and they will be reached sooner than those that only receive a phone call or only a text message. In addition, patients will be given reminder cards at the time of testing to remind them that they will be contacted within 7 days if they test positive. Half of the reminder cards will have a number to call for test results. We believe patients that receive a card with a number are more likely to be contacted within 7 days.
Read the detailed description
Aim 1: To improve the results notification system among all female adolescents who test positive for STIs in the ED using mobile phone texting technology.
Hypothesis 1: We will increase our contact rate for STI positive adolescents in the ED from 65-82%.
Hypothesis 2: We will decrease the time interval between testing and appropriate STI treatment by the ED.
Hypothesis 3: We will decrease the recidivism rates for STI positive patients diagnosed in the ED.
Aim 2: To explore qualitatively the barriers to and preferences for partner notification and treatment among 14-21 year-old females and males being tested for STIs in the ED.
Aim 3: To determine baseline rates of partner notification and preferences around partner notification among STI-positive females in the ED, and to explore the feasibility of ED personnel notifying their sexual partners.
- Conditions
- Sexually Transmitted Infections
- Being tested
- Call when test results are ready, Text message when test results are ready, Call and text message when test results are ready
- Keywords
- STI, STD
- 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.
Call when test results are readyOther
Patients are called when the test results are ready
Text message when test results are readyOther
Patients receive a text message when results are ready
Call and text message when test results are readyOther
Patients receive both a call and a text message when test results are resay
| Study group | Role | What they receive |
|---|---|---|
| Reminder card with no number | Other | Patients receive a card to remind them of the time frame for results but no number is listed. Receives: Other: Call when test results are ready; Other: Text message when test results are ready; Other: Call and text message when test results are ready |
| Card with number | Other | Patients receive a card to remind them of the time frame for results but and a number to call for results is listed Receives: Other: Call when test results are ready; Other: Text message when test results are ready; Other: Call and text message when test results are ready |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact rate
The percentage of patients that are contacted within 7 days of their emergency department visit
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Jennifer Reed, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938053
- Sponsor's protocol ID
- K12HD051953 Reed
- Other IDs
- K12HD051953
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2013
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
- ClinicalTrials.gov ID
- NCT01938053
- Acronym / sponsor ID
- K12HD051953 Reed
- Conditions
- Sexually Transmitted Infections
- Keywords
- STI, STD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Sep 2013 (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 primary goal of this project is to improve the process for contacting patients that test positive for a sexually transmitted infection (STI) in the emergency department by using text messaging. We believe patients that are contacted by both a phone call and a text message will be reached more often and they will be reached sooner than those that only receive a phone call or only a text message. In addition, patients will be given reminder cards at the time of testing to remind them that they will be contacted within 7 days if they test positive. Half of the reminder cards will have a number to call for test results. We believe patients that receive a card with a number are more likely to be contacted within 7 days.
Detailed description
Aim 1: To improve the results notification system among all female adolescents who test positive for STIs in the ED using mobile phone texting technology.
Hypothesis 1: We will increase our contact rate for STI positive adolescents in the ED from 65-82%.
Hypothesis 2: We will decrease the time interval between testing and appropriate STI treatment by the ED.
Hypothesis 3: We will decrease the recidivism rates for STI positive patients diagnosed in the ED.
Aim 2: To explore qualitatively the barriers to and preferences for partner notification and treatment among 14-21 year-old females and males being tested for STIs in the ED.
Aim 3: To determine baseline rates of partner notification and preferences around partner notification among STI-positive females in the ED, and to explore the feasibility of ED personnel notifying their sexual partners.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminder card with no number | Other | Other: Call when test results are ready, Other: Text message when test results are ready, Other: Call and text message when test results are readyPatients receive a card to remind them of the time frame for results but no number is listed. |
| Card with number | Other | Other: Call when test results are ready, Other: Text message when test results are ready, Other: Call and text message when test results are readyPatients receive a card to remind them of the time frame for results but and a number to call for results is listed |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 14 to 21 years old
- Seen in the emergency department at Cincinnati Children's Hospital Medical Center
- Test positive for an STI
Key exclusion criteria (2 listed)
- Seen for a psychiatric evaluation
- Seen for sexual assault or abuse
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 |
|---|---|---|
| Call when test results are readyPatients are called when the test results are ready | Other | Card with number, Reminder card with no number |
| Text message when test results are readyPatients receive a text message when results are ready | Other | Card with number, Reminder card with no number |
| Call and text message when test results are readyPatients receive both a call and a text message when test results are resay | Other | Card with number, Reminder card with no number |
Primary outcome
Contact rate
Time frame: 7 days
The percentage of patients that are contacted within 7 days of their emergency department visit
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 16 Sep 2020.
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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.
Jennifer Reed, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Call when test results are ready, Text message when test results are ready and Call and text message when test results are ready in people with Sexually Transmitted Infections, run by Children's Hospital Medical Center, Cincinnati 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 2 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 16 Sep 2020. 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?
Contact rate (time frame: 7 days). 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 16 Sep 2020.