drugset / Trial / NCT05853120

Doxy-Post-exposure Prophylaxis

NCT05853120

RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this project is to collect data regarding the ability of various oral doses of doxycycline to penetrate mucosal tissues in men and women to inform the combination of doxycycline with antiretrovirals (ARVs) for the development of single-dose event-driven multipurpose prevention strategies to protect against HIV and sexually transmitted infections (STIs). This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs. The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures. Recruitment: Both face-to-face and online engagements will be conducted to recruit study participants. Face-to-face locations include bars and nightclubs, community organizations serving study populations, sports events, and community venues, and online engagements include dating sites, social networks, and craigslist, amongst other social medial platforms.

Timeline

Start
2023-05-31
Primary completion
2024-09-25
Completion
2024-12-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxycycline Small molecule 100 mg Oral
Comparator Doxycycline Small molecule 200 mg Oral