Home test kits provide young women with a safe and effective means for protecting their sexual reproductive health

Researchers at Johns Hopkins say they have evidence that more than one-third of young women are willing and able to use a free, easily available home test kit to privately and accurately learn if they are infected with Chlamydia trachomatis, the most common sexually transmitted disease (STD) in this group.

Among the women, mostly under age 25, who used the kit -- developed by Hopkins -- 87 percent did so by ordering it on the Internet. The kit, which costs about $10 to manufacture, was provided free for study participants.

"Our results confirm that home test kits ordered via the Internet provided young women with a safe and effective means for protecting their sexual reproductive health," says 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. "The Internet is how the current generation does business -- from researching homework to shopping for clothes. Not surprisingly, they prefer using the Internet to also help take care of their health."

The Hopkins findings, to be presented at the 105th general meeting of the American Society for Microbiology on June 8, are believed to be the first to show that online access to self-sampling test kits for Chlamydia is an effective way to address the spread, detection and treatment of the disease. This age group also has the highest risk of contracting an STD and has historically been the least likely group to undergo regular testing.

Results of a new survey by the same investigators, also to be presented at the ASM meeting, warn that reinfection rates for Chlamydia were alarmingly high among middle- and high-school students in Baltimore, Md.

"Teenagers and young adults are frequently left unaware for years that they have Chlamydia because symptoms may not appear for long periods after infection," says Gaydos.

In the case of Chlamydia, for example, 80 percent to 90 percent of those infected develop no symptoms, putting them at extremely high risk of pelvic inflammatory disease, a condition that can leave a woman infertile from resulting scar tissue. "Many of these hidden and untreated cases occur in women who lack health insurance and cannot afford to pay for tests or regular check-ups, the easiest way to detect this infection and prevent others from becoming exposed," she says.

In the study, free kits funded by the City of Baltimore Health Department were made available to women in Maryland for a six-month period starting in August 2004. Kits could be ordered through a designated Internet site (www.iwantthekit.org) or could be picked up from any one of 250 participating pharmacies and recreation centers.

Inside each kit was a packaged, sterile vaginal swab and instructions for using it. Also enclosed were 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 were tested for Chlamydia and gonorrhea, another common STD. The kits were mailed in plain, brown paper envelopes and contained a detailed questionnaire, allowing the researchers to gather important information about who used the kit and why.

Of the 1,100 kits distributed, 400 samples were returned to Hopkins by January 2005, and 10 percent were positive for Chlamydia. Only three women tested positive for gonorrhea. Results were made available to the women within two weeks via a secured telephone answering service that used kit numbers and passwords. For women who tested positive for Chlamydia or gonorrhea, referrals were also provided to a local community health clinic for treatment, as part of the confirmation telephone message.

Ninety-five percent of women who tested positive for Chlamydia sought treatment, which, according to Gaydos, is almost twice as high as the rate found among people seeking care in health clinics. The researchers say study participants may have been more highly motivated to seek treatment, but suggest that easy access to testing may have been responsible for at least some of the improvement. Final results of the gonorrhea testing have not yet been analyzed or published.

Of those tested who ordered the kit rather than picking it up in person, 87 percent used the Internet, and half were younger than age 25. Eighty-nine percent said they preferred to test themselves rather than go to a clinic, and 93 percent rated the kit as easy to use. Study participants reported that self-collection was preferable to having a physician perform a pelvic exam, which for some can cause discomfort and be embarrassing, the researchers say. Earlier studies showed that self-collected vaginal swabs are as effective as a doctor's cervical exams for diagnosing STDs. Indeed, 29 percent of respondents had not had a regular physical exam within the past year.

"The home test kit is important because it offers physicians and nurses another tool in efforts to reduce the spread of Chlamydia -- both locally and nationally," says Gaydos.

Home test kits are still available to people who live in Maryland, and the study remains open through to the end of 2005. The researchers have plans next year to expand their research to include women in the District of Columbia. They also plan to develop within five years a home test kit that also tests for trichomoniasis; human papillomavirus, or HPV; and HIV, the virus that causes AIDS.

According to the United States Centers for Disease Control and Prevention (CDC), all people under age 25 who are also sexually active should be regularly screened for Chlamydia.

The pilot study was launched in Baltimore, Md., in part because of the city's high prevalence of STDs. In 2003, the last year for which statistics are available, Baltimore had the sixth highest incidence (reported new cases per year) in the nation for Chlamydia (at 6,413 cases, behind Rochester, N.Y., Philadelphia, Pa., Detroit, Mich., Richmond, Va., and St. Louis, Mo.) In previous years, the city ranked third and second. According to the CDC's biannual survey of risky youth behaviors, 32 percent of students are sexually active by the ninth grade.

In a related survey to determine why the number of Chlamydia infections remains high, the researchers examined lab results from Chlamydia tests, collected from 1994 to 2004, on students at Baltimore area schools, looking for cases of reinfection among young people ages 11 to 18.

"It is hard enough to find and treat young people for Chlamydia, but our overall mission is to keep them healthy and free from getting reinfected," says Gaydos.

Out of nearly 1,000 students who tested positive for Chlamydia at 11 area schools and were successfully treated, the researchers found that, within one year, 26 percent of girls and 20 percent of boys were reinfected with the STD. These numbers were considerably higher than the 7 percent to 13 percent rates for reinfection reported nationally by the CDC, whose guidelines call retesting three to four months after infection.

Gaydos believes that once treated, students are either continuing to have sex with an untreated partner or are becoming infected from new sex partners who are infected.

"Regardless the underlying causes of risky sex behaviors, our study affirms the need for more screening and testing of students for STDs," she says.

Funding for the survey analysis was provided by the Baltimore City Health Department.

Other researchers involved in this research were Sabina Mahmutovic, M.D.; Catherine Wright, B.S.; Mathilda Barnes, B.S.; Karen Dwyer, B.S.; Billie Jo Wood, M.S.; Patricia Rizzo-Price, M.S.; Toni Fleming, B.S.; M. Terry Hogan, M.P.H.; Rebecca Miller, B.S.; Patricia Agreda, B.S.; Gerry Waterfield, C.P.N.P.; Sharon Hobson, C.P.N.P.; Alain Joffe, M.D.; and Thomas C. Quinn, M.D.