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ChlamydiaNCT01140022

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

An observational study of Chlamydia and Screening, run by University of California, San Francisco at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Chlamydia, Screening
What is being tested?
CT Screening
How many people
346 participants
Where
6 sitesUnited States
Study dates
Sep 2007to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • CMC Fresno Emergency Department

    Fresno, California, 93701

  • Alameda County Medical Center, Highland Hospital

    Oakland, California, 94602

  • San Francisco General Hospital - Emergency Department

    San Francisco, California, 94110

  • San Francisco General Hospital, Urgent Care

    San Francisco, California, 94110

  • UCSF Emergency Deparmtent

    San Francisco, California, 94143

  • UCSF Screening and Acute Care Clinic

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the 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.

Conditions
Chlamydia, Screening
Being tested
CT Screening
Keywords
Chlamydia, Screening, young women, kiosk, computer module
Medical subject headings
Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT ScreeningOther

    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.

Study groups in NCT01140022
Study groupRoleWhat they receive
Female Patients 18-25 yoFemale 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.
Receives: Other: CT Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of female patients 18-25yo receiving CT screening during ED or UC visit.

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

Secondary outcomes (1)
  1. Acceptability of module and intervention among patients and staff.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2010 (estimated)
  2. Study startSep 2007
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140022
Sponsor's protocol ID
H1095-31344
Status last verified
Oct 2014
First submitted
18 May 2010
Last updated
3 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chlamydia and Screening, run by University of California, San Francisco at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.

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