HIV Pre-exposure Prophylaxis Implementation Study in South Korea
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of adherence to PrEP with TDF/FTC
研究概览
简要总结
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.
详细描述
- Primary Objectives
• To examine acceptability, patterns of use, rates of adherence, safety , and measured levels of drug when high risk MSM are provided open-label TDF/FTC for PrEP in South Korea 2. Secondary Objectives
- To evaluate HIV incidence among study participants
- To evaluate risk behavior and risk compensation among study participants
- To identify barriers and facilitators of PrEP among study participants
- Study design Prospective, open-label cohort study assessing PrEP delivery in tertiary hospital infectious diseases clinics in South Korea for 1 year
- Evaluation
- Baseline evaluation
- HIV testing and the documentation of results are required to confirm that patients do not have HIV infection when they start taking PrEP medications. HIV Ag/anti HIV Ab combo assay should be performed before starting PrEP. Negative result of HIV Ag/anti HIV Ab combo assay within 1 week should be ascertained before PrEP initiation. Results from rapid test with oral specimen or unreliable testing results cannot be acknowledged.
- Renal function with estimated creatinine clearance (eCrCl) should be evaluated before starting TDF/FTC. TDF/FTC can be prescribed for persons with eCrCl ≥60 ml/min. Any person with an eCrCl of <60 ml/min should not be prescribed PrEP with TDF/FTC.
- Testing for hepatitis B virus (HBsAg, HBsAb) and hepatitis C virus (HCV Ab) should be performed before starting PrEP. Hepatitis B virus vaccination is recommended for MSM without HBsAb.
- Acute HIV infection must be excluded by symptom history, physical examinations and appropriate HIV testing before PrEP is prescribed.
- If HIV testing shows intermediate results, clinician should hold PrEP initiation, make efforts to identify symptoms and signs of acute viral infections, and do follow up HIV testing.
- Follow up and monitoring during PrEP
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Serious medical or psychiatric comorbidities
- •Taking nephrotoxic medications
- •Suspected acute HIV infection by physician
研究组 & 干预措施
PrEP
干预措施: tenofovir disoproxil fumarate (TDF) 300mg co-formulated with emtricitabine (FTC 200mg) once daily oral administration (Drug)
结局指标
主要结局
Rate of adherence to PrEP with TDF/FTC
时间窗: 12 months
Rate of adherence will be measured by self report using visual analogue scale, pill counts, and drug concentration.
次要结局
- 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)
- Number of participants who are willing to continue PrEP(1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months)
- Reasons of non-adherence to PrEP among study participants(1) 3 months, 2) 6 months, 3) 9 months, 4) 12 months)