Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia

Chlamydia Clinical Trial

Official title:

Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140022
• Other study ID #: H1095-31344
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: October 1, 2014
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: University of California San Francisco Committee on Human Research
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to conduct a quality improvement intervention to improve the ability of health care providers to deliver an important preventive health service (CT screening) in order to meet the goal of universal CT screening for young women age 25 or younger as recommended by the CDC and virtually all major health organizations. This novel approach utilizes a bilingual (English-Spanish) computer kiosk module to deliver education about CT and allow patients to request a CT screening test. This module should significantly increase CT screening among at risk women (18-25yo) attending urgent care clinics and emergency departments.

Description:

Chlamydia trachomatis (CT) remains epidemic among sexually young adult and adolescent females especially ethnic minority women. Despite recommendations for at least annual screening of all sexually active women up to age 25, CT screening rates remain low. Most young women do not regularly attend primary care clinics where preventive care such as CT screening should be done; and clinicians lack time and comfort to address CT screening during the context of an urgent care or emergency department visit. This proposed study takes advantage of a "missed opportunity" for screening these at-risk young women for CT when they come in contact with the health care system during an urgent care or emergency department visit. The purpose of this study is to conduct a quality improvement intervention, to improve the ability of health care providers to deliver an important preventive health service (CT screening) in order to meet the goal of universal CT screening recommended by virtually all major health organizations. CT screening should be done as a routine part of health care but currently is not. In this study, we will help providers do what they should already be doing using this novel health care delivery approach. In this study, we created and are evaluating a bilingual (English-Spanish) computer kiosk module to increase CT screening among at risk English and Spanish speaking women (18-25 yo) attending urgent care clinics and emergency departments (ED). This computer technology will be able to conduct many of the steps necessary for CT screening including assessing clients' CT risk and prompting the client and health care professionals for CT urine specimen collection. This study will also examine the extent to which this computer kiosk module intervention use is acceptable and feasible among both English and Spanish speaking young women, and health care professionals who care for them in urgent care and ED settings. This type of intervention to improve CT screening is potentially translatable to a wide variety of health delivery settings as it is not dependent on staff time, motivation or skill to assess sexual history in the busy urgent care setting. This project also supports current recommendations of Healthy People 2010, the U.S. Preventive Services Task Force and other professional organizations to screen all sexually active young adult females at least annually for CT to address this important public health problem especially among our young ethnic minority women who carry the largest STI disease burden. Early detection through routine CT screening coupled with appropriate treatment of CT infections can eliminate widespread infection and prevent such major reproductive morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• English or Spanish speaking

• Medically Stable

• Sexually active

• Female

• 18-25 years old

• Seeking health services in participating urgent care clinics and ED in San Francisco/Bay Area, California.

Exclusion Criteria:

• Clients who do not speak English or Spanish will not be eligible to participate.

• Males of any age because there is no CDC recommendation to universally screen this group.

• Women who have never had sexual intercourse are not eligible as this is a study of how to increase screening for chlamydia, a sexually transmitted infection.

• For Kiosk, clients with moderate and major trauma or illness requiring immediate medical intervention, as assessed by triage nurse as part of routine protocol, will be excluded from participation.

• Anyone who chooses not to participate (as this is voluntary) will be excluded from participation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections
• Screening

Intervention

Other:
• CT Screening
Patients will use a kiosk module that will provide information about CT screening and assess their risk for CT. Patients choosing to get a CT screening will receive a printout instructing the provider or nurse to collect a urine sample for CT screening.

Locations

Country	Name	City	State
United States	CMC Fresno Emergency Department	Fresno	California
United States	Alameda County Medical Center, Highland Hospital	Oakland	California
United States	San Francisco General Hospital - Emergency Department	San Francisco	California
United States	San Francisco General Hospital, Urgent Care	San Francisco	California
United States	UCSF Emergency Deparmtent	San Francisco	California
United States	UCSF Screening and Acute Care Clinic	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of female patients 18-25yo receiving CT screening during ED or UC visit.		one year prior to the patient's clinic or ED visit.	No
Secondary	Acceptability of module and intervention among patients and staff.		one year prior to the patient's clinic or ED visit.	No