HIV Pre-exposure Prophylaxis Implementation Study in South Korea

NCT04583267 | Unknown

• 1 other identifier: 4-2018-0671
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Rate of adherence to PrEP with TDF/FTC

  Rate of adherence will be measured by self report using visual analogue scale, pill counts, and drug concentration.

  3 months

• Rate of adherence to PrEP with TDF/FTC

  Rate of adherence will be measured by self report using visual analogue scale, pill counts, and drug concentration.

  6 months

• Rate of adherence to PrEP with TDF/FTC

  Rate of adherence will be measured by self report using visual analogue scale, pill counts, and drug concentration.

  9 months

• Rate of adherence to PrEP with TDF/FTC

  Rate of adherence will be measured by self report using visual analogue scale, pill counts, and drug concentration.

  12 months

Secondary Outcomes (7)

• Number of participants with decreased eGFR

  1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months

• Number of participants who experienced adverse events related to TDF/FTC

  1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months

• Rate of condom use of participants

  1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months

• Number of sexual partners of participants

  1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months

• Incidence of sexually transmitted diseases

  1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months

Study Arms (1)

PrEP

EXPERIMENTAL

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

Interventions

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

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

PrEP

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious medical or psychiatric comorbidities
• Taking nephrotoxic medications
• Suspected acute HIV infection by physician

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Racivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Yong Choi

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yong Choi

CONTACT

+82-2-2228-1974; seran@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 12, 2020
• Study Start: August 28, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)