Thai Red Cross AIDS Research Centre (TRC-ARC)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Primary outcome measures:
研究概览
简要总结
PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •HIV test negative
- •Creatinine clearance > 60 ml/min
- •No contraindication or allergy to PrEP medications (TDF/FTC)
- •At least one risk factor for HIV infection within the previous 6 months:
- •sex partner known to be HIV positive
- •works as commercial sex worker
- •use of PEP for sexual exposure
- •injection drug use
- •any STI (syphilis, gonorrhea, chlamydia)
- •> 5 sex partners
- •inconsistent condom use with high-risk partners, including MSM, IDU
- •MSM: any insertive or receptive anal sex without condom
- •Women: any sex without condom with high-risk male partner (MSM, IDU, multiple female partners)
- •Heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, IDU, multiple male partners)
排除标准
- 未提供
结局指标
主要结局
Primary outcome measures:
时间窗: 12 months
1. Assess the uptake of fee-based oral PrEP by MSM and other at-risk individuals who present for HIV testing or other services. 2. Assess the acceptability, tolerance and safety of oral PrEP. 3. Assess patient satisfaction with oral PrEP delivered through a fee-based system in an HIV testing center. 4. Assess the effectiveness of oral PrEP in a fee-based model. 5. Assess the cost-effectiveness of oral PreP delivered in a fee-based system.
次要结局
未报告次要终点