Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.
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To assess the proportion of participants who are eligible and consent to participate amongst those approached.
Timeframe: 15 months
To assess the proportion of participants reporting > 95% adherence to study drug, according to self-report and pill counts.
Timeframe: 15 months
To assess the proportion of individuals with therapeutic doxycycline drug level (defined at ≥ 1000 ng/mL) at each study time point.
Timeframe: 15 months
To assess the proportion of individuals reporting grade 3 or 4 adverse events in each study arm.
Timeframe: 15 months
Proportion of individuals with adverse event-related study drug discontinuation in each study arm.
Timeframe: 15 months