Chlamydia Infections Clinical Trial
Official title:
Use of Self-collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of women rescreened for chlamydia |
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