HIV Pre-exposure Prophylaxis Implementation Study in South Korea
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to examine acceptability, patterns of use, rates of
adherence, safety , and measured levels of drug when high risk men who have sex with men
(MSM) are provided open-label tenofovir/emtricitabine (TDF/FTC) for PrEP in South Korea.
Secondary objectives are 1) to evaluate HIV incidence among study participants, 2) to
evaluate risk behavior and risk compensation among study participants, and 3) to identify
barriers and facilitators of PrEP among study participants. The design of this study is a
prospective, open-label cohort study assessing PrEP implementation in tertiary hospital
infectious diseases clinics in South Korea for 1 year. Baseline data will be collected 1
months before initiation of PrEP, and the date of initiation of PrEP. All persons receiving
PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess
side effects, adherence, and HIV acquisition risk behaviors. Drug concentration will be
measured every 6 months. It is anticipated that approximately 100 Korean MSM will be enrolled
in this study.