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HIV Pre-exposure Prophylaxis Implementation Study in South Korea

NCT04583267 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-12

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

tenofovir disoproxil fumarate (TDF) 300mg co-formulated with emtricitabine (FTC 200mg) once daily oral administration

Participants will take tenofovir disoproxil fumarate (TDF) 300mg co-formulated with emtricitabine (FTC 200mg) once daily oral administration for preventing HIV infection.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jun Yong Choi · Severance Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583267 on ClinicalTrials.gov