Bacterial sexually transmittd diseases (STD's), the most common of which is C. trachomatis, are major causes of reproductive morbidity among women in the U.S.. Advances in technology for detecting STD's offer the novel opportunity for home-based self- screening. However, whether such a strategy could enhance adherence with screening has not been examined in this country. We propose a randomized clinical trial to evaluate the effectiveness of home-testing versus return clinic visits for screening of STD's among high risk women. Women aged 14-29 with documented C. trachomatis cervicitis will be enrolled from family planning services, STD clinics, adolescent clinics and gynecology clinics in Pennsylvania and South Carolina. Baseline characteristics including risk factors for STDs and attitudes about screening will be collected. Women will be randomly assigned in equal numbers to 1) home samplings vs. 2) return visits for screening. At 6, 12, and 18 months, the two groups will then receive either 1) self-sampling vaginal swabs that they can elect to be mailed home or picked-up or 2) post-card reminders to return to the enrollment site for screening. Swabs will be tested at a central laboratory for C. trachomatis and N. gonorrhoeae by DNA amplification. All women with STD's detected will bu urged to return for treatment, and all obtained treatment will be recorded. Main analyses will compare between home screening and return visit groups: 1) proportion of screening tests completed; 2) proportion of women with C. trachomatis infections detected by screening. Secondary analyses will include: 1) proportion of women with N. gonorrhoeae detected by screening; 2) proportion of detected chlamydia/gonococcal infections treated; 3) attitudes towards screening. At two years after enrollment, we will recontact all study participants (both those who complied with screening and those that did not). All participants will be interviewed by telephone and asked to complete a self-collected vaginal swab for C. trachomatis and N. gonorrhoeae infections. Based on these end-of-study data, secondary analyses will compare between study group: 1) the proportion of women with C. trachomatis after the screening period; 2) the proportion of women who sought care for PID during the study. This study will determine whether a home screening strategy for bacterial STD's would enhance compliance with screening recommendations; such a strategy could contribute to elimination of STD's at reduced societal cost.
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