HIV Pre-exposure Prophylaxis Implementation Study in South Korea

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yonsei University
• Treatments: Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• MSM

• Adults

• Participants have to be HIV negative by a fourth generation HIV antigen/antibody (Ag/Ab) test

• Urine dipstick with negative or trace protein

• eGFR ≥60 mL/min

• HBsAg negative

• Condomless anal sex in the past 6 months or diagnosed with at least one STI in the past 6 months

Exclusion Criteria:

• Serious medical or psychiatric comorbidities

• Taking nephrotoxic medications

• Suspected acute HIV infection by physician