NCT00132457

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,830 (estimated)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Chlamydia Infections

Interventions

Type	Name	Description
PROCEDURE	Self-collected vaginal swab for chlamydia testing

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-08-22
• Last updated: 2010-01-07

Locations

3 sites across 1 country: United States