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

Chlamydia Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132457
• Other study ID #: CDC-NCHSTP-4274
• Secondary ID: U36/CCU319276
• Status: Completed
• Phase: N/A
• First received: August 18, 2005
• Last updated: January 6, 2010
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: January 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1830
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Infection

Intervention

Procedure:
• Self-collected vaginal swab for chlamydia testing

Locations

Country	Name	City	State
United States	The Mississippi State Department of Health, Bureau of STD/HIV	Jackson	Mississippi
United States	Louisiana State University (LSU) Health Sciences Center	New Orleans	Louisiana
United States	Washington University	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of women rescreened for chlamydia