Westat
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
Participants will be randomized to receive on-demand doxycycline post-exposure prophylaxis (doxyPEP), weekly doxycycline, or standard of care (SOC) and will be followed quarterly to assess the impact of doxycycline use on the quarterly incidence of STIs (gonorrhea \[GC\], chlamydia \[CT\], and early syphilis), and within the doxycycline arms adherence and acceptability of weekly versus on-demand dosing. Approximately 760 females will be randomized 1:1:1 to (1) on-demand doxyPEP (doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex), (2…
Inclusion Criteria: * Age 13-29 years, inclusive; * Self-reports GC, CT, and/or early syphilis diagnosis in the 12 months prior to screening; * Self-reports condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening * Is at least 45 kilograms (99.2 pounds) in weight * Fluent in English (able to read, speak, and understand English); * Willing to undergo all required study procedures; and * Willing to provide written informed consent to participate in the study. Exclusion Criteria: * Is male; * Is pregnant, breastfeeding, or planning to become pregnant…
200 mg of doxycycline taken by mouth as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex along with STI screening and sexual health counseling
200 mg of doxycycline taken by mouth weekly regardless of sexual activity along with STI screening and sexual health counseling
Quarterly STI testing/treatment and sexual health counseling