Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,612
- 试验地点
- 1
- 主要终点
- Proportion of all patients tested for plasma CrAg who have positive results
研究概览
简要总结
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
详细描述
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.
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
- 否
入选标准
- •Aged ≥ 18 years
- •Confirmed HIV infection using National Testing Algorithm
- •CD4 ≤100 cells/μL
- •Able to provide written informed consent
排除标准
- •History of prior CM
- •Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
- •Currently taking ART or history of ART for more than 4 weeks within the past year
- •Known to be currently pregnant or planning to become pregnant during the study period
研究组 & 干预措施
CrAg(+) and CM(+)
Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.
干预措施: Fluconazole (Drug)
CrAg(+) and CM(-)
Patients with CrAg(+) and without CM symptoms will be treated with high-dose fluconazole. The initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months.
干预措施: Fluconazole (Drug)
CrAg negative
Patients with CrAg negative results will be managed as other HIV positive patients according to the national guidelines
干预措施: Fluconazole (Drug)
结局指标
主要结局
Proportion of all patients tested for plasma CrAg who have positive results
时间窗: Up to 12 months after recruitment
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
时间窗: Up to 12 months after recruitment
次要结局
- Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative(12 months after recruitment)
- % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment(12 months after recruitment)
- Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months(12 months after recruitment)
- Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation(12 months after recruitment)
- Percent of patients with HIV-related hospitalizations at 6 and 12 months(12 months after recruitment)
- Causes of death(12 months after recruitment)