跳至主要内容
临床试验/NCT04265573
NCT04265573已完成不适用

Feasibility, Acceptability and Costs of a Strategy Deploying Multiple First-lines Artemisinin-based Combination Therapies for Uncomplicated Malaria: a Pilot Programme in the Health District of Kaya, Burkina Faso

Groupe de Recherche Action en Sante1 个研究点 分布在 1 个国家目标入组 150,000 人开始时间: 2018年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150,000
试验地点
1
主要终点
Number of favourable and unfavourable opinions from various profiles of informants about the MFT pilot program.

研究概览

简要总结

A simultaneous deployment of multiple first line therapies (MFT) for uncomplicated malaria using artemisisin based combination therapies as showed by theoretical models, may extend the useful therapeutic life of the current Artemisinin-based combination thérapies (ACTs) by reducing drug pressure and slowing the spread of resistance without putting life at risk. We therefore hypothesized that a simultaneous deployment of three ACTs targeting three segments of the population is feasible, acceptable and can achieve high coverage rate if potential barriers are well identified, well addressed and the key implementers are well-trained and adequately supported. To test this hypothesis, a quasi-experimental study will be conducted.

详细描述

The study will be conducted through four overlapping phases: formative research phase, the MFTs deployment phase, the evaluation phase and the post-evaluation phase.

  1. Formative research phase

1.1 Objective

Generate baseline information and to develop intervention tools for the pilot implementation of MFTs for uncomplicated malaria in the study area.

1.2 Design

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Household survey
  • Caregivers, adults, pregnant women
  • Signed consent form

排除标准

  • 未提供

结局指标

主要结局

Number of favourable and unfavourable opinions from various profiles of informants about the MFT pilot program.

时间窗: From the formative phase to the end of drugs deployment: 18 months duration.

Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants.

次要结局

  • Average number of monitoring visits performed per annum(Through the MFTs deployment phase: 12 months of duration.)
  • Average number of monitoring visits on which health facilities have stock out of mRDTs per annum.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of community resources people with unfavourable opinions to the MFTs pilot program.(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Average number of monitoring visits on which drugs stores have stock out of any dose of study ACTs per annum.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who did not received any antimalarial.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who received an ACT.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of febrile episode seen at health facility level.(Through the MFTs deployment phase: 12 months of duration)
  • Proportion of febrile episodes treated with ACTs adhering to ACT treatment schedule (timing and doses) by HWs according to MFTs strategy(During MFTs deployment phase at peak malaria season: 6 months of duration.)
  • Cost per additional inappropriate antimalarial treatment avoided.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of febrile episode seen at health facility level (HFL) within 24 hours(Through the MFTs deployment phase: 12 months of duration)
  • Proportion of febrile episode seen at HFL within 24 hours and tested for parasitemia.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of febrile episode seen at HFL within 24 hours with positive diagnostic test who were given ACT according to the MFTs strategy(Through the MFTs deployment phase: 12 months of duration.)
  • Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of uncomplicated fever episodes/malaria seen by HW, tested positive and treated with correct dose of ACT according to MFTs pilot program(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Proportion of uncomplicated febrile episode/malaria seen at health facility level before and during the MFTs deployment in the study area.(Through the MFTs deployment phase: 12 months of duration.)
  • Proportion of community resources people with favourable opinions to the MFTs pilot program.(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Incidence of uncomplicated febrile episode/malaria within 4 weeks preceding the surveys(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Source of advice or care for those suffering from fever in the last four weeks(From the formative phase to the end of drugs deployment: 18 months duration.)
  • The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis(Through the MFTs deployment phase: 12 months of duration)
  • The total cost per capita of intervention (provider perspective)(Through the MFTs deployment phase: 12 months of duration)
  • Proportion of episode of uncomplicated fever seen by HWs tested for malaria parasitemia.(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Proportion of uncomplicated febrile episodes/malaria seen by HWs provided with advice on danger signs.(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Mortality rate related to febrile episode/malaria before and during the pilot MFTs deployment.(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Proportion of individuals with fever in the last four weeks for whom advice or treatment was sought(From the formative phase to the end of drugs deployment: 18 months duration.)
  • The total cost per capita of intervention (societal perspective)(Through the MFTs deployment phase: 12 months of duration)
  • Proportion of febrile episodes treated with ACTs according to MFTs pilot programme by HWs provided with appropriate dosing advice(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Proportion of individuals with fever in the last four week who sought treatment at HFL within 24 hours(From the formative phase to the end of drugs deployment: 18 months duration.)
  • Cost to the HWs to participate to the MFTs strategy.(Through the MFTs deployment phase: 12 months of duration.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验