A Hybrid Effectiveness-implementation Study to Assess the Effectiveness and Chemoprevention Efficacy of Implementing Seasonal Malaria Chemoprevention in Five Districts in Karamoja Region, Uganda
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,805
- 试验地点
- 1
- 主要终点
- Chemoprevention failure
研究概览
简要总结
To-date, seasonal malaria chemoprevention (SMC) has only been scaled up across the Sahel region of west and central Africa, primarily because of concerns over widespread resistance to sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) in east and southern Africa. There are increasing calls for this successful intervention to be used more widely and aggressively, including in areas of east and southern Africa where malaria transmission is seasonal. To test the feasibility, acceptability and impact of SMC with SPAQ in new geographies outside of the Sahel, Malaria Consortium, together with the malaria programmes in Mozambique and Uganda, is conducting implementation studies in both countries. The studies comprise two phases, with the first phase focusing on acceptability and feasibility, followed by more rigorous assessments of the effectiveness of the intervention and chemoprevention efficacy of the medicines used in SMC.
Phase 1 of the studies has been successfully completed. The studies showed that SMC with SPAQ was safe, acceptable and feasible, with very high coverage achieved among the target population.Phase 2 of the SMC implementation study in Uganda will include study components exploring the effectiveness of SMC with SPAQ and dihydroartemisinin-piperaquine (DP), as well as the chemoprevention efficacy of DP when used in SMC. The study will be conducted in five districts of Karamoja region. It will involve SMC delivery to around 142,000 children. The majority of the target population will receive SPAQ, but around 15,000 children will receive DP. Five monthly SMC cycles will be implemented between May and September 2022. As the protective period of SPAQ and DP are comparable, monthly administration cycles will be implemented irrespective of the drug regimen used.
详细描述
The study aims to test the effectiveness and chemoprevention efficacy of seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine (SPAQ) and dihydroartemisinin-piperaquine (DP) in the Karamoja region of Uganda. Specific objectives are:
- to determine the effectiveness of SMC using SPAQ and DP;
- to determine the chemoprevention efficacy of SPAQ and DP when used for SMC;
- to investigate the presence and change of SPAQ and DP resistance markers over time as a result of SMC implementation;
- to evaluate the process of SMC implementation, including coverage, quality of SMC implementation, costing, feasibility and acceptability, as well as an assessment of the role of gender in SMC implementation.
Study design This type 2 hybrid effectiveness-implementation study uses a convergent mixed-methods approach. SMC will be implemented in five monthly cycles between June 2022 and October 2022 in five districts of Karamoja. Table 2 provides an overview of the study components, as well as where and when they will be conducted, as well as the implementing partner and the proposed funding source.
Table 2. Uganda SMC implementation study phase 2: study components. Study component Primary outcome Objective Location Timing Implementing partner Funding Cluster randomised controlled trial Clinical malaria 1 Amudat May 2022 (baseline) and October 2022 (endline) Malaria Consortium Philanthropic Malariometric survey Malaria prevalence 1 Amudat May 2022 (baseline) and October 2022 (endline) Malaria Consortium Philanthropic Chemoprevention efficacy cohort study Chemoprevention failure Drug concentrations and drug resistance genotypes among chemoprevention failures 2 Nakapiripirit May/June 2022 (28 days following distribution of the first monthly SMC cycle) IDRC Bill & Melinda Gates Foundation Resistance markers study Prevalence of antimalarial resistance markers 3 Amudat, Kotido, Moroto, Nabilatuk, Nakapiripirit April 2022 (baseline) and November 2022 (endline) IDRC Bill & Melinda Gates Foundation End-of-round household survey Coverage and quality of SMC implementation 4 Amudat, Kotido, Moroto, Nabilatuk October 2022 Malaria Consortium Bill & Melinda Gates Foundation Cost-effectiveness analysis Cost-effectiveness 4 n/a November 2022 Malaria Consortium Philanthropic Key informant interviews and focus group discussions Feasibility and acceptability of SMC implementation 4 Amudat, Kotido, Moroto, Nabilatuk August-October 2022 Malaria Consortium Bill & Melinda Gates Foundation Methods
Malaria Consortium seeks funding from the Bill & Melinda Gates Foundation for the following study components:
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
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 3-59 months
- •Being resident in the project area
- •Afebrile with no other malaria associated symptoms in the past 48 hours or at time of recruitment
- •Consent to participate in the study obtained
- •Can comply with 3 days DOT of standard SPAQ or DP regimen (day 0-2)
- •Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections
排除标准
- •Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)
- •Known allergy to medicine provided
- •Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).
- •Individuals receiving azithromycin due to the antimalarial activity of azithromycin.
- •Severe malnutrition according to WHO guidelines
- •Treatment of uncomplicated malaria with DP in the past 28 days
- •HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)
- •Chronic illness of any kind
- •Recruited in cRCT or any other studies
- •Treatment with an ACT in previous 2 weeks.
研究组 & 干预措施
Intervention SMC - SPAQ
This arm will receive SPAQ as seasonal malaria chemoprevention
干预措施: Sulfadoxine pyrimethamine and amodiaquine (Drug)
Intervention SMC - SP
This arm will receive SP as seasonal malaria chemoprevention
干预措施: dihydroartemisinin-piperaquine (Drug)
结局指标
主要结局
Chemoprevention failure
时间窗: 1 month
As defined by qPCR positive parasites on day 28 for SPAQ and DP) or malaria slide positive parasites at any time from day 7
Chemoprevention efficacy
时间窗: 1 month
As defined by drug concentrations on Day 7 and Day 28
Malaria incidence
时间窗: Four months
Malaria cases recorded through passive surveillance
次要结局
- Anemia(Four months)
- 28 day malaria incidence(1 month)