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

NCT00132457 | Completed

• 2 other identifiers: CDC-NCHSTP-4274U36/CCU319276
• Study Type: interventional
• Target: 1,830
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chlamydia Infections

Keywords

Chlamydia; screening; Sexually transmitted disease

Outcome Measures

Primary Outcomes (1)

• Percent of women rescreened for chlamydia

Interventions

Self-collected vaginal swab for chlamydia testing PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (3)

Louisiana State University (LSU) Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

The Mississippi State Department of Health, Bureau of STD/HIV

Jackson, Mississippi, 39216, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Xu F, Stoner BP, Taylor SN, Mena L, Tian LH, Papp J, Hutchins K, Martin DH, Markowitz LE. Use of home-obtained vaginal swabs to facilitate rescreening for Chlamydia trachomatis infections: two randomized controlled trials. Obstet Gynecol. 2011 Aug;118(2 Pt 1):231-239. doi: 10.1097/AOG.0b013e3182246a83.

  PMID: 21775837 DERIVED

MeSH Terms

Conditions

Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fujie Xu

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: October 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

US (3)