The study will measure how many women make use of the kit, determine disease prevalence among respondents, record how effectively test results can be returned to the participants, and assess how well respondents who test positive follow through with therapy.
The overall aim of the researchers is to replicate the successful introduction of widely used home pregnancy tests and lower the rates of sexually transmitted diseases (STDs) among young women, who are most at risk of contracting an STD and least likely to undergo regular check-ups for disease prevention.
"Many women are left unaware for years that they have an STD because symptoms do not commonly appear for long periods after infection," said study lead investigator and infectious disease specialist Charlotte Gaydos, M.S., Dr.P.H., associate professor of medicine at The Johns Hopkins University School of Medicine. "Indeed, Chlamydia is 80 to 90 percent without any symptoms of infection, and it can take two to three years before infected women develop signs of pelvic inflammatory disease, a condition that can leave a woman infertile from resulting scar tissue."
Funded by the U.S. Centers for Disease Control, the study test kit will be available only in Maryland, and at participating pharmacies and some recreation centers. The kit consists of a packaged, sterile vaginal swab and instructions for using it. Also enclosed are sealed containers for the self-collected swabs and return envelopes with postage paid for mailing the samples back to a laboratory at Johns Hopkins, where they will be tested.
Results will be available within two weeks via a secured telephone answering service that uses kit numbers and passwords. For women who test positive for Chlamydia or gonorrhea, a referral is also provided to a local community health clinic for treatment, as part of the confirmation telephone message.
More than 500 kits are available as part of the initial pilot program. They are available at locations listed on the Web site: www.iwantthekit.org. The kits are contained in plain, brown-paper packaging meant to resemble a typical prescription. An advertising campaign in community newspapers, promoting the Web site, will accompany the study, expected to last six months.
Research shows that self-collected vaginal swabs are as effective as a doctor's cervical exams for diagnosing STDs. Earlier focus groups suggested that young women preferred the privacy of home sampling and the convenience of picking up kits, at no cost, from either within their home community or through the Internet.
"Our hope is to provide young women with a safe and effective means for protecting their sexual reproductive health that is also easy to use," added Gaydos. "If this home-test kit works, we will have another tool in our efforts to reduce the spread of STDs through outreach tactics for disease prevention. We can also use these tests as an early-warning system to control future outbreaks - both locally and nationally."
According to the CDC, all people under the age of 25 who are also sexually active should be regularly screened for common STDs, such as Chlamydia and gonorrhea.
The pilot study was launched in Baltimore, Md., in part, because of the city's high prevalence for STDs. In 2002, the last year for which statistics are available, Baltimore had the third highest incidence (new cases per year) for Chlamydia (at 6,267 cases, behind Detroit, Mich., and Richmond, Va.) and gonorrhea (at 4,873 cases, behind St. Louis, Mo., and Richmond, Va.)