Study design
STIS
This is an open-label 1:1 randomized clinical trial evaluating the efficacy of doxycycline PEP to reduce incident curable, bacterial STIs – Demographic and behavioural data were electronically collected (REDCap), including questionnaires on STI and HIV risk perception and potential exposures. Biological sample collection (including serum, endocervical and vaginal swabs) and testing were done by trained study clinicians and laboratory technologists on site. Rapid HIV testing was completed using HIV 4th generation combination test (Abbott Determine) followed by confirmation for any positive results using repeat HIV antibody rapid testing (First Response) and then enzyme linked immunosorbent assay (ELISA) testing per Kenyan National Guidelines. Testing for This study is an open-label, randomized clinical trial of doxycycline hyclate (200 mg taken up to 72 hours after sex, with no more than 200 mg each day) to reduce bacterial STIs. Participants were randomized 1:1 to doxycycline PEP vs. standard of care using computer-based randomization (Randomize.net). The trial’s plan to enrol 446 participants was determined based on an anticipated 66 women with new STIs (We present descriptive statistics, and compared the detection of an STI (