|
|
|
|
|
|
Sponsored by: |
Centers for Disease Control and Prevention |
Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00132457 |
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 |
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 |
Estimated Enrollment: | 1830 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fujie Xu, MD | 404-639-1899 | fax1@cdc.gov |
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 |
Principal Investigator: | Fujie Xu | Centers for Disease Control and Prevention |
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 |
|
|
|
|