Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01140022
First received: May 18, 2010
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Chlamydia
Screening
Other: CT Screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Leveraging Technology as a Clinician Extender to Screen Culturally Diverse Young Women for Chlamydia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Proportion of female patients 18-25yo receiving CT screening during ED or UC visit. [ Time Frame: one year prior to the patient's clinic or ED visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of module and intervention among patients and staff. [ Time Frame: one year prior to the patient's clinic or ED visit. ] [ Designated as safety issue: No ]

Enrollment: 346
Study Start Date: September 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Female Patients 18-25 yo
Female patients aged 18-25 who have come to one of the ED or urgent care sites for care, regardless of the presence of CT symptoms.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female patients 18-25 yo receiving care at urgent care or ED sites.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140022

Locations
United States, California
CMC Fresno Emergency Department
Fresno, California, United States, 93701
Alameda County Medical Center, Highland Hospital
Oakland, California, United States, 94602
San Francisco General Hospital - Emergency Department
San Francisco, California, United States, 94110
San Francisco General Hospital, Urgent Care
San Francisco, California, United States, 94110
UCSF Emergency Deparmtent
San Francisco, California, United States, 94143
UCSF Screening and Acute Care Clinic
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
HRSA/Maternal and Child Health Bureau
Investigators
Principal Investigator: Mary-Ann Shafer, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01140022     History of Changes
Other Study ID Numbers: H1095-31344
Study First Received: May 18, 2010
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board
United States: University of California San Francisco Committee on Human Research

Keywords provided by University of California, San Francisco:
Chlamydia, Screening, young women, kiosk, computer module

Additional relevant MeSH terms:
Chlamydia Infections
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on November 23, 2014