Health Care Provider Use of Plasmodium Vivax Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- To assess health care provider (HCP) compliance to a revised case management algorithm for vivax malaria that involves providing radical cure (RC) after G6PD testing and a follow-up visit on day 3 days [+ 2 days])
研究概览
简要总结
The goal of this study is to evaluate the operational feasibility of using a new treatment algorithm for Malaria Vivax in Peru.
The implementation package includes the following interventions:
- A revised vivax treatment algorithm that incorporates new Radical Cure tools (G6PD test + Tafenoquine or Primaquine)
- The training of Health Care Providers ( HCPs) in the revised algorithm and the use of the new RC tools
- Patient counselling
- A follow-up visit at Day 3 [+2 days] for patients after treatment start
- Accompanying supporting measures: job aids, strengthening of supervision and PV processes
详细描述
The goal of this study is to evaluate the operational feasibility of providing Tafenoquine and Primaquine after semi-quantitative G6PD testing at different levels of the health services, in order to inform potential policy change, malaria strategy, and introduction planning.
This implementation research study will be carried out in Peru .The study will be conducted in Loreto Region (Loreto, Maynas and Ramon Castilla provinces), an area which is endemic for P. vivax.
A total of 30 health facilities will be included: 6 in the first phase and 12 will be added in the second phase. An additional 12 health facilities have been selected as backup in case the malaria case load is low, and this is needed in order to meet the sample size.
All relevant HCP working in study facilities will be trained on the relevant aspects of performing the G6PD testing, interpreting its result, evaluating patient's eligibility for Radical Cure and choosing the appropriate treatment as per their role accordingly.
HCP knowledge and skills regarding semi-quantitative G6PD testing and RC treatment will be assessed through standardized competency assessment (including self-assessments).
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health Care Providers:
- •All HCPs working in the selected facilities who are involved in the management of vivax patients.
- •Inclusion criteria patients:
- •All patients aged 6 months onward, who have a confirmed P. vivax infection and who are treated in a study Health Facilities
- •Pregnant and lactating women, who have a contra-indication to both Primaquine and Tafenoquine, but for whom correct case management will be evaluated as part of the primary endpoints.
- •Patients providing informed consent and/or informed assent
排除标准
- •Patients with signs of severe infection
结局指标
主要结局
To assess health care provider (HCP) compliance to a revised case management algorithm for vivax malaria that involves providing radical cure (RC) after G6PD testing and a follow-up visit on day 3 days [+ 2 days])
时间窗: Time from Malaria Vivax diagnosis until FU visit 3 days [+ 2 days]
Percentage of patients that were correctly treated with RC \[chloroquine (CQ) plus either primaquine (PQ) or tafenoquine (TQ)\] based on the revised algorithm
次要结局
未报告次要终点