NCT01140022

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 3, 2014

Status Verified

October 1, 2014

Enrollment Period

4.8 years

First QC Date

May 18, 2010

Last Update Submit

October 1, 2014

Conditions

Keywords

Chlamydia, Screening, young women, kiosk, computer module

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Acceptability of module and intervention among patients and staff.

    one year prior to the patient's clinic or ED visit.

Study Arms (1)

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

Interventions

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.

Female Patients 18-25 yo

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • English or Spanish speaking
  • Medically Stable
  • Sexually active
  • Female
  • years old
  • Seeking health services in participating urgent care clinics and ED in San Francisco/Bay Area, California.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CMC Fresno Emergency Department

Fresno, California, 93701, United States

Location

Alameda County Medical Center, Highland Hospital

Oakland, California, 94602, United States

Location

San Francisco General Hospital - Emergency Department

San Francisco, California, 94110, United States

Location

San Francisco General Hospital, Urgent Care

San Francisco, California, 94110, United States

Location

UCSF Emergency Deparmtent

San Francisco, California, 94143, United States

Location

UCSF Screening and Acute Care Clinic

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Chlamydia Infections

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Mary-Ann Shafer, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2010

First Posted

June 9, 2010

Study Start

September 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 3, 2014

Record last verified: 2014-10

Locations