Operational Evaluation of Mass Screening and Treatment Using Ultrasensitive Rapid Detection Tests to Reduce P. Falciparum Incidence in a Malaria Elimination Program in Eastern Kayin State, Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,542
- 试验地点
- 1
- 主要终点
- Adjusted incidence rate ratio before/after MSAT
研究概览
简要总结
In this project, the investigators aim at an operational research deployment of Ultrasensitive Rapid Diagnostic Test (URDT) -based Mass Screening and Treatment (MSAT) in the Malaria Elimination Task Force (METF) elimination program. This intervention will be tested in two types of setting. In group 1, MSAT will be used in a programmatic setting in order to decrease the reservoir of asymptomatic carriers in high incidence villages (following the same principles and objective as previously deployed MDA interventions). In group 2, the investigators take advantage of the lighter framework of MSAT to use it as a reactive intervention in order to respond to malaria outbreaks in low to intermediate incidence villages. The MSAT intervention will be preceded with community-level consent and community engagement (CE) activities. MSAT will be conducted over a period of approximately 1 week in each hamlet, village or group of villages, and will consist in administering a P. falciparum URDT to all individuals agreeing to participate. A limited subgroup (expected 5-25%) will be found positive and receive supervised treatment over 3 days for the standard regimen (DP to cure asexual stage infection + single low-dose primaquine to destroy gametocytes). After this intervention, the incidence of clinical falciparum episodes will be monitored by the village MP. In group 1, a comparison of the prevalence at baseline and 12 months after MSAT intervention will be performed through a second URDT survey, in addition to which both baseline and 12-month surveys will include the collection of a 200µL capillary blood sample for reference detection in the laboratory.
The intervention will be evaluated primarily on its ability to reduce yearly cumulative incidence of clinical falciparum malaria compared to year before intervention. Additional evaluations of the impact of MSAT will include: in group 1, comparison of asymptomatic infection prevalence; and in group 2, modifications of the shape of the incidence curve following intervention.
Funder: Wellcome Trust grant reference 106698/B/14/Z
详细描述
STUDY DESIGN
Stepped-wedge open-label, non-randomized, cluster intervention.
This study will be performed in clusters (hamlet (isolated group of household, village, or group of village). The intervention will be conducted in two types of clusters, both corresponding to locations where an excess of case was detected.
Group 1: Sustained high incidence clusters, characterized by a yearly cumulative incidence >84 cases/1000/year
Villages in group 1 will be attributed an intervention a given year based on the cumulative incidence over the previous 12 months (METF stratification January, including the last 2 transmission seasons). The order of intervention will be decided based on logistic constraints and highest incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All persons living in the village or cluster of villages will be eligible for MSAT intervention.
- •Individuals living in smaller settlements (permanent or temporary) within walking distance of a selected intervention village will also be eligible.
- •Large "work-related" settlements in the vicinity of a targeted village (military camps, logging camp, mining site) will be approached by the team to be included in the screening and treatment activity. They will be included in the analysis as a unit within a cluster of villages if all the study information can be collected (including follow-up survey for Group 1).
排除标准
- •Individuals who do not provide informed consent for both URDT screening and treatment in case of positive result. Individuals will be given the possibility to refuse the collection of the 200µL reference sample or the DBS collection but participate to URDT screening and treatment.
- •Children <1 year old
- •Individuals with a documented Pf-positive malaria RDT who received treatment (AL+sld PMQ) during the previous 7 days.
- •NB: Individuals who were diagnosed infected with PF and received a treatment between 7 and 30 days before the intervention are still likely to be URDT positive due to the persistence of HRP2, and this will result in treatment of individuals who are likely uninfected. However, in a high prevalence area or in an outbreak context, previous infection signals exposure, and DP will provide a protection against a likely re-infection.
研究组 & 干预措施
Sustained high incidence villages
Villages classified as high incidence, low probability of elimination (P. falciparum cumulative incidence >84 cases/1000/year, in spite of >1 year of functioning malaria post) will be eligible to be included in group 1. Villages in this group will be addressed by MSAT waves of 10-15 villages. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs.
干预措施: Ultrasensitive Rapid Diagnostic Test (URDT) (Diagnostic Test)
Sustained high incidence villages
Villages classified as high incidence, low probability of elimination (P. falciparum cumulative incidence >84 cases/1000/year, in spite of >1 year of functioning malaria post) will be eligible to be included in group 1. Villages in this group will be addressed by MSAT waves of 10-15 villages. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs.
干预措施: Antimalarials (Drug)
Seasonal focal transmission villages/locations
This group will follow the NMCP case/and foci investigation guidelines, but use URDT instead of standard RDT for screening. MSAT group 2 locations will be cluster of houses, villages or clusters of villages selected based on the results of case or foci/outbreak investigation. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs.
- Village inclusion after case investigation
- Village inclusion after outbreak investigation
干预措施: Ultrasensitive Rapid Diagnostic Test (URDT) (Diagnostic Test)
Seasonal focal transmission villages/locations
This group will follow the NMCP case/and foci investigation guidelines, but use URDT instead of standard RDT for screening. MSAT group 2 locations will be cluster of houses, villages or clusters of villages selected based on the results of case or foci/outbreak investigation. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs.
- Village inclusion after case investigation
- Village inclusion after outbreak investigation
干预措施: Antimalarials (Drug)
结局指标
主要结局
Adjusted incidence rate ratio before/after MSAT
时间窗: 12 month
次要结局
- % of P. falciparum positive samples by reference method which were positive by URDT and treated; % of P. falciparum negative samples by reference method which were positive by URDT and treated (group 1)(3 years)
- Change in the incidence dynamics over the transmission season (group 2)(3 years)
- The percentage of participant among village resident tested by URDT.(3 years)
- Prevalence of P. falciparum infection measured in the village by URDT and by reference method (group 1)(12 months)