Clinical trial NCT00132457: Use of Self-collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection
Official title: Use of Self-collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Infections
Keywords: Chlamydia
screening
Sexually transmitted disease
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-08-22
Enrollment: 1830
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of women rescreened for chlamydia
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University (LSU) Health Sciences Center
state: Louisiana
city: Jackson
country: United States
facility: The Mississippi State Department of Health, Bureau of STD/HIV
state: Mississippi
city: St Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Fujie Xu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.