Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique: A Country-specific Public Health Evaluation." (CDC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 3
- 主要终点
- 1. What proportion of HIV-infected adult patients with common signs and symptoms can be assigned specific, potentially treatable diagnoses or syndromic classifications when evaluated in conformity with new Mozambican algorithms?
研究概览
简要总结
Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this project seeks to assess the effectiveness of a subset of the new Mozambican clinical guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to determine response to initial and/or second-line therapy) of common signs and symptoms in HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the new guidelines will be described; they will be compared to the previous standard of care for the problem(s) of interest, and the clinical importance of differences between guidelines designed for Mozambican non-physician clinicians and new guidelines (also issued in late 2009) for Mozambican physicians will be described. The subset of guidelines to be addressed in the current phase of this 2-year project includes algorithms for diagnosis and management of acute fever, persistent fever, and anemia.
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
- •> 18 years old
- •HIV-infected
- •Fever > 37.5° C or history of fever
- •Anemia with recorded hemoglobin level <10 mg/dL
排除标准
- •Primary language/dialect is not spoken or understood by any member of the study team.
- •Participants who meet algorithm-driven definitions of "danger signs" related to the condition of interest at the time of screening
- •Pregnant women will be excluded only if they meet the following criteria (in labor, or in need of emergency Caesarean section or dilatation and curettage)
结局指标
主要结局
1. What proportion of HIV-infected adult patients with common signs and symptoms can be assigned specific, potentially treatable diagnoses or syndromic classifications when evaluated in conformity with new Mozambican algorithms?
时间窗: 6 months
次要结局
- 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)(6 months)
- 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?(6 months)
- What proportion of HIV-infected adult patients with common signs and symptoms improve clinically when evaluated and managed in conformity with new Mozambican algorithms for técnicos de medicina?(6 months)
- What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?(6 months)
- For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.(6 months)
- What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?(6 months)
研究者
Troy Moon
Assistant Professor Department of Pediatric Infectious Diseases
Vanderbilt University