After the Flood: Optimal Strategies to Prevent Malaria Epidemics Caused by Severe Flooding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36,000
- 试验地点
- 1
- 主要终点
- A. Cluster-level Incidence of malaria in children ≤ 12 years of age
研究概览
简要总结
The purpose of this study is to test different ways to prevent malaria infections after flooding. To accomplish this, the investigators will assign villages to different control strategies and measure the number of malaria infections in each of the villages. Residents of all villages will receive new bed nets, but in some villages, residents will be provided with a monthly medication Dihydroartemisinin-piperaquine (DP) (a drug that is approved by the World Health Organization (WHO) and regulatory authorities and widely used in Africa for Malaria treatment. This drug is not approved by Food and Drug Administration (FDA) because it is not used in the US,) to prevent malaria, while others will also receive a treatment that can be placed into pools of water around the home to prevent mosquitoes from breeding there. The investigators will monitor the participant and their household members for mosquitoes and malaria over a period of 12 months after the flooding This study is important because, similar approaches could be used to prevent malaria after floods, which is occurring more frequently.
详细描述
The study is an open-label, cluster randomized controlled trial in fifty villages prone to predictable, but often catastrophic annual flooding in a malaria-endemic area of western Uganda.
STUDY DESIGN The investigators will conduct an open-label, cluster randomized controlled trial in approximately 50-60 villages prone to predictable, but often catastrophic annual flooding in a malaria-endemic area of western Uganda. In the first year, the investigators will conduct baseline surveys of participating households, including geographic variables (e.g., elevation, proximity to river) and measures such as malaria transmission intensity (Plasmodium falciparum Positivity Rate (PfPR)) to stratify risk. The unit of randomization will be the sub-village, defined as the geographic area of responsibility for each community health worker, typically comprised of approximately 200-300 residents living in 30-40 distinct households. The N=144 sub-village (clusters) will be stratified based on pre-flood malaria transmission intensity and randomized 1:1:1 within each stratum to either control (i.e.,Long-lasting Insecticidal Net (LLIN only)) or one of the two intervention groups (DP or DP+Bti). Participants will be followed longitudinally for a period of 12-months after the index flood event. The investigators will conduct facility-based surveillance for parasitologically-confirmed, symptomatic malaria cases, measure PfPR, assess entomological risk, and socioeconomic impacts of the intervention(s).
STUDY ENROLLMENT AND WITHDRAWAL Strategies for Recruitment and Retention Sensitization Meetings & Community Dissemination The investigators will conduct a series of sensitization meetings with sub-county and village leadership in each of the study areas to inform them of the aims and methods of the study. These meetings will be followed similar events with community health workers (CHWs), who will be asked to disseminate the information, as well as the proposed dates of the baseline surveys, to households in their respective coverage areas.
Enrollment On the day of the baseline survey, study staff, guided by the local CHW, will approach each household in the sub-village. If an adult (age ≥18 years) household member is present, study staff, fluent in Lukhonzo, will review the aims and methods of the study and ask for written consent to participate. Children 8 - 17 years of age will be asked to provide written assent. Households without an adult present will be revisited two additional times, after which the household will be geolocated, but considered not participating.
Participant Incentives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent resident of flood-prone village in Kasese District with no plans to change residency in subsequent 12 months
- •Able and willing to comply with all study procedures and be available for the duration of the study
- •Able and willing to consent to study procedures as documented on informed consent form (ICF). For children (age <18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.
排除标准
- •Temporary or part-time residence in study village
- •Plans to move in the next 12 months
- •Unable or unwilling to provide consent.
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
研究组 & 干预措施
Control Arm: Provision of new Long-lasting Insecticidal Net (LLIN(s) the participant household
Control Arm: Provision of new LLIN(s) to bring the household up to WHO "universal coverage" targets defined as one LLIN per every two household residents.
干预措施: Long-lasting Insecticidal Net (Other)
Dihydroartemisinin Piperaquine(DP)+Bacillus thuringiensis israelensis(Bti)
LLIN + DP + Bti In addition to receipt of LLIN(s) and DP, study staff will provide the adult participant with an 8-oz packet of Bti, a pair of latex gloves, a teaspoon, and a tracking form. A staff member will then survey an area (50 m radius) around the house and demonstrate appropriate application in up to 5 potential breeding sites. Household members will be instructed to repeat application every 2 weeks for the 3 months post-flooding.
干预措施: Dihydroartemisinin piperaquine + Bacillus thuringiensis israelensis (Combination Product)
Dihydroartemisinin Piperaquine (DP)
LLIN + monthly DP for children ≤12 years of age In addition to receipt of LLIN(s) as described above, children ≥2 to ≤12 years of age will be screened for DP administration. If no contraindications are noted, weight-based DP will be administered by the parent/caregiver under the supervision of the study team. Participants will be observed for ~ 30 minutes. Any adverse events will be documented. Tablets for administration on Days 2 and 3 will be provided. Administration will be repeated at months 2 and 3 post-flooding.
干预措施: Dihydroartemisinin piperaquine (Drug)
结局指标
主要结局
A. Cluster-level Incidence of malaria in children ≤ 12 years of age
时间窗: up to 12 months after the flooding
The cluster-level incidence of confirmed, symptomatic malaria in children ≤ 12 years of age, defined as fever (Temp ≥38 degrees Celsius (°C)) or a subjective history or fever in the prior 24 hours as the cause of care seeking and a positive malaria diagnostic test (i.e., Rapid Diagnostic Test (RDT) or microscopy), per 1,000 residents over the twelve-month period of observation. Incident cases will be captured at neighboring health facilities. In addition, the investigators will conduct a series of household surveys at baseline and 1-, 3-, 6-, and 12-months post-flooding in order to monitor temporal changes in the spatial distribution of malaria parasitemia, vector populations, and resulting social/economic impacts.
次要结局
- Change in WHO Indicators of Chronic Malnutrition in children <5 years of age(baseline, 6, and 12-months post flooding.)
- A. Cluster-level Incidence of malaria among all residents(1-, 3-, 6-, and 12-months post flooding.)
- Change in prevalence of anemia in children <5 years of age(baseline, 6-, and 12 months after the flooding)
- Change in WHO Indicators of Acute Malnutrition in children <5 years of age(baseline, 6, and 12-months post flooding.)
- Prevalence of parasitemia in children(1-, 3-, 6-, and 12-months post flooding.)
- Hospitalization for malaria(12 months after the flooding)
- Cluster-level change in Anopheles density and species composition(12 months after the flooding)
- Prevalence of juvenile Anopheles within peri-domestic space(12 months after the flooding)
- Cluster-level change in blood-fed and parasite-carrying Anopheles(12 months after the flooding)
- Cost-effectiveness of interventions (DP, DP+Bti) compared to control (LLINs)(12 months after the flooding)
- Adherence to intervention components (LLIN, DP, and Bti)(12 months after the flooding)