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

January 6, 2010 updated by: Centers for Disease Control and Prevention
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University (LSU) Health Sciences Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • The Mississippi State Department of Health, Bureau of STD/HIV
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent of women rescreened for chlamydia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Fujie Xu, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-4274
  • U36/CCU319276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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