The Thai Red Cross AIDS Research Centre
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
- 试验地点
- 11
- 主要终点
- Type of Clients
研究概览
简要总结
Data from a total of 2,500 walk-in or referred individuals who have been confirmed (diagnosed) HIV positive and accessing care and treatment services at the hospitals targeted by this study will be examined. The starting period for this project is estimated to be the last quarter (Q4) of fiscal year 2018.
详细描述
This 24-month observation study will be conducted in 13 hospitals of 5 provinces in Thailand: Chiang Rai, Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. The research team of TRCARC will collect and analyze secondary and de-identified data from the hospitals' databases. In each site, clients who agree to receive Same-Day ART service will go through standard of care procedures at each hospital, which include: post-test counseling and psychosocial support, baseline lab test, clinical screening, and physical examination. The drug regimen prescribed for clients will mirror the first line ART regimen in Thailand's national guideline, which is tenofovir (TDF), emtricitabine (FTC), and efavirenz (EFV). Retention of the clients will reflect that of the hospital's protocol, and CD4 and viral load will be tested according to the national guideline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thai nationals
- •HIV-positive status
- •Acceptance of Same-Day ART
排除标准
- •not Acceptance of Same-Day ART
结局指标
主要结局
Type of Clients
时间窗: 5 years
Type of Clients (newly diagnosed or re-engaged)
Number of clients categorized by demographic characteristics
时间窗: 5 years
Demographic Characteristics: age (years), gender (sex at birth and gender identity), risk behavior(s), and reason(s) for HIV testing
Number of clients with each ART drug regimen differ from first line ART regimen
时间窗: 5 years
Drug regimen, if different from first line drug (TDF, FTC, EFV)
Number of clients with each clinical exclusion criteria
时间窗: 5 years
Clinical exclusion criterias : suspected TB, suspected cryptococcal meningitis, suspected serious OIs
Viral load count
时间窗: 5 years
Viral load count (VL tested, percentage of VL suppressed, and dates of VL suppressed)
Duration between date of HIV diagnosis and date of ART initiation
时间窗: 5 years
Duration between date of HIV diagnosis and date of ART initiation
Duration between date of ART initiation to date of being successfully transferred and date of ART continuation
时间窗: 5 years
Duration of linkage to care, if applicable (date of being successfully transferred and date of ART continuation)
Retention
时间窗: 5 years
Retention (retention in care, discontinued ART, loss to follow-up, death) at month 1, month 3, month 6, and month 12 after ART initiation
Acceptance
时间窗: 5 years
Acceptance of Same-Day ART
Number of clients with each clinical characteristic
时间窗: 5 years
Clinical Characteristics based on Thailand's national guidelines (anti-HIV, creatinine, alanine transaminase, syphilis serology, hepatitis B antigen, hepatitis C antibodies, urinalysis, chest X-ray, CD4 count, CDC stage, comorbidity)
次要结局
未报告次要终点