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

Primary Purpose

Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Call when test results are ready
Text message when test results are ready
Call and text message when test results are ready
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sexually Transmitted Infections focused on measuring STI, STD

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Reminder card with no number

Card with number

Arm Description

Patients receive a card to remind them of the time frame for results but no number is listed.

Patients receive a card to remind them of the time frame for results but and a number to call for results is listed

Outcomes

Primary Outcome Measures

Contact rate
The percentage of patients that are contacted within 7 days of their emergency department visit

Secondary Outcome Measures

Full Information

First Posted
September 5, 2013
Last Updated
September 14, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01938053
Brief Title
Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Official Title
Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
Keywords
STI, STD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reminder card with no number
Arm Type
Other
Arm Description
Patients receive a card to remind them of the time frame for results but no number is listed.
Arm Title
Card with number
Arm Type
Other
Arm Description
Patients receive a card to remind them of the time frame for results but and a number to call for results is listed
Intervention Type
Other
Intervention Name(s)
Call when test results are ready
Intervention Description
Patients are called when the test results are ready
Intervention Type
Other
Intervention Name(s)
Text message when test results are ready
Intervention Description
Patients receive a text message when results are ready
Intervention Type
Other
Intervention Name(s)
Call and text message when test results are ready
Intervention Description
Patients receive both a call and a text message when test results are resay
Primary Outcome Measure Information:
Title
Contact rate
Description
The percentage of patients that are contacted within 7 days of their emergency department visit
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Reed, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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