Targeting High-risk Populations With Enhanced Reactive Focal Mass Drug Administration: A Study to Assess the Effectiveness and Feasibility for Plasmodium Falciparum and Plasmodium Vivax Malaria in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,977
- 试验地点
- 2
- 主要终点
- PCR-based P. falciparum and P. vivax parasite prevalence in sampled sub-districts
研究概览
简要总结
This study assesses the effectiveness of reactive focal mass drug administration (rfMDA), targeting both village and forest working populations, compared to control for reducing the health promotion hospital-level (sub-district) incidence and prevalence of P. falciparum and P. vivax within five provinces in Thailand.
详细描述
Thailand currently has a well-developed and robust surveillance system based on detailed mapping of all cases to the village foci level and stratification of response. In fiscal year 2019, 5,833 cases of malaria were reported with 83.0% P. vivax and 12.9% P. falciparum; nine deaths were reported. This represents a 20.8% decrease in total cases from fiscal year 2018. Currently, there are 701 "A1" villages in 44 provinces.
The research proposed here will evaluate the effectiveness and feasibility of enhanced reactive focal mass drug administration, results of which will have direct implications for continued roll out the community-led foci management, providing practical guidance that other malaria programs can utilize. Responding to the malaria among high risk populations is a requirement from the National Malaria Elimination Strategy in Thailand. Additionally, Thailand has experienced outbreaks related to forest work over the past several years, and consequently the Department of Vector Borne Disease (DVBD) is interested in introducing more aggressive parasite elimination strategies, including rfMDA for P. falciparum and P. vivax specifically targeting high-risk populations to interrupt transmission and rapidly accelerate elimination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Index cases: Presented as a confirmed malaria case to an intervention health facility or village malaria worker, and lives in a village within a selected intervention subdistrict, or worked or spent at least one night at a forest or forest-fringe site in the past 30 days located within an intervention subdistrict
- •Village residents: Lives in a village within a selected intervention subdistrict area and in one of the five households closest to the residence of an index case of malaria
- •Co-worker/traveler referral: Worked or traveled and spent at least one night in forest in past 30 days in same location within an intervention subdistrict as an index case of malaria
- •All participants: Willing and available to participate in the study and informed consent for participant under the age of 18 will be provided by the parent or guardian. Participants for focus group discussions (FGDs) and key informant interviews (KIIs); 18 years of age or older
排除标准
- •For rfMDA:
- •Previous participation in the study as a result of any rfMDA event in the past 30 days
- •Individuals with severe disease or drug contra-indications will be excluded from the treatment component only
- •Artesunate-Mefloquine: Pregnancy in the first trimester, or known drug allergy
- •Use of Mefloquine within 60 days of first treatment prior to enrollment date.
研究组 & 干预措施
reactive focal mass drug administration (rfMDA)
Reactive FMDA (rfMDA) led by VMVs in response to cases in study area sub-district, in both villages and forest workers; quantitative G6PD testing for all individuals and 14-day PQ for G6PD non-deficient.
干预措施: Case Management and Follow-up (Other)
reactive focal mass drug administration (rfMDA)
Reactive FMDA (rfMDA) led by VMVs in response to cases in study area sub-district, in both villages and forest workers; quantitative G6PD testing for all individuals and 14-day PQ for G6PD non-deficient.
干预措施: Reactive focal mass drug administration (rfMDA) (Other)
Control
Standard of care including case management through health facilities and malaria posts/VMVs; village-based RACD conducted by district staff in some areas.
干预措施: Case Management and Follow-up (Other)
结局指标
主要结局
PCR-based P. falciparum and P. vivax parasite prevalence in sampled sub-districts
时间窗: 3 months
Defined as the proportion of individuals ≥18 months old with P. falciparum or P. vivax infection (detected by PCR) out of all individuals ≥18 months tested within the end line survey.
Confirmed P. falciparum and P. vivax malaria parasite incidence
时间窗: 3 months
Defined as the number of outpatient (OPD) malaria confirmed and suspected cases per person per year for each sub-district, as ascertained from the health facility registers, utilizing administrative catchment population size estimates for the exposure denominator.
次要结局
- Adverse event rate(3 months)
- Acceptability of rfMDA approach(3 months)
- Population coverage of rfMDA interventions(3 months)
- Feasibility of conducting rfMDA at the community level(3 months)
- Operational feasibility of glucose-6-phosphate dehydrogenase (G6PD) testing and referral(3 months)
- Assessment of P. vivax treatment adherence(3 months)