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Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938053
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date September 16, 2020
Study Start Date  ICMJE April 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Contact rate [ Time Frame: 7 days ]
The percentage of patients that are contacted within 7 days of their emergency department visit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Official Title  ICMJE Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Sexually Transmitted Infections
Intervention  ICMJE
  • Other: Call when test results are ready
    Patients are called when the test results are ready
  • Other: Text message when test results are ready
    Patients receive a text message when results are ready
  • Other: Call and text message when test results are ready
    Patients receive both a call and a text message when test results are resay
Study Arms  ICMJE
  • Reminder card with no number
    Patients receive a card to remind them of the time frame for results but no number is listed.
    Interventions:
    • 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
    Patients receive a card to remind them of the time frame for results but and a number to call for results is listed
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2013)
609
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 14 to 21 years old
  • Seen in the emergency department at Cincinnati Children's Hospital Medical Center
  • Test positive for an STI

Exclusion Criteria:

  • Seen for a psychiatric evaluation
  • Seen for sexual assault or abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938053
Other Study ID Numbers  ICMJE K12HD051953 Reed
K12HD051953 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE University of Cincinnati
Investigators  ICMJE
Principal Investigator: Jennifer Reed, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP