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Use of Self-Collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection

This study is currently recruiting participants.
Verified by Centers for Disease Control and Prevention, September 2007

Sponsored by: Centers for Disease Control and Prevention
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00132457
  Purpose

The purpose of this study is to determine if, among women who were treated for a prior chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for chlamydia in comparison with rescreening in the clinic. The study design is two randomized trials with enrollment at multiple family planning clinics and sexually transmitted disease (STD) clinics following a common protocol.


Condition Intervention
Chlamydia Infections
Procedure: Self-collected vaginal swab for chlamydia testing

MedlinePlus related topics:   Chlamydia Infections    Sexually Transmitted Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Use of Self-Collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Percent of women rescreened for chlamydia

Estimated Enrollment:   1830
Study Start Date:   October 2003
Estimated Study Completion Date:   March 2008

Detailed Description:

The study consists of two complementary trials, denoted as Part A and Part B. In Part A, women/girls who had a positive test for chlamydia will be enrolled when they visit the study clinics for treatment. After written informed consent is obtained, women will be randomly assigned to the Clinic Group, in which they will be advised to return to the clinic for rescreening for chlamydia, or the Home Group, in which women will be asked to collect a vaginal swab at home and mail it to the study laboratory for chlamydia testing. In part B, women who were tested and empirically treated for a chlamydial infection will be called if their tests were positive. Enrollment will be offered over the phone after verbal consent. Rescreening will be scheduled 3 months after treatment of the initial infection for women in both trials.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Women/girls with a lab-confirmed genital chlamydia infection

Exclusion Criteria:

  • Women who are pregnant, or are trying to conceive in the following 3 months.
  • Women who are planning to move in the following 3 months or currently living outside the study areas.
  • Inability to understand spoken English adequately to assure informed consent and compliance with study procedures.
  • Self-reported HIV infection; other serious illnesses or disability.
  • Self-reported allergy to macrolide antibiotics such as azithromycin.
  • Referrals from providers or clinics other than the STD or family planning clinics, unless women are re-tested at the STD clinics and test positive for chlamydia.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132457

Contacts
Contact: Fujie Xu, MD     404-639-1899     fax1@cdc.gov    

Locations
United States, Louisiana
Louisiana State University (LSU) Health Sciences Center     Recruiting
      New Orleans, Louisiana, United States, 70112
      Contact: David H Martin, MD     504-568-5031        
United States, Mississippi
The Mississippi State Department of Health, Bureau of STD/HIV     Recruiting
      Jackson, Mississippi, United States, 39216
      Contact: Leandro Mena, MD     601-987-6728        
United States, Missouri
Washington University     Recruiting
      St Louis, Missouri, United States, 63110
      Contact: Bradley Stoner, MD, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Fujie Xu     Centers for Disease Control and Prevention    
  More Information


Study ID Numbers:   CDC-NCHSTP-4274, U36/CCU319276
First Received:   August 18, 2005
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00132457
Health Authority:   United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Chlamydia  
screening  
Sexually transmitted disease  

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases
Chlamydia Infections
Genital Diseases, Male
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Bacterial
Communicable Diseases
Chlamydiaceae Infections
Infection

ClinicalTrials.gov processed this record on November 05, 2008




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