Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will be conducted through four overlapping phases: formative research phase, the MFTs deployment phase, the evaluation phase and the post-evaluation phase. 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 Cross-sectional surveys using desk reviews, qualitative and quantitative research methods: Individual in-depth Interviews Focus group discussions Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation Health facility-based surveys for malaria morbidity and mortality, antimalarial drugs and malaria rapid diagnostic tests availability. 1.3 Duration Six months from obtaining the approval of the ethics committee for health research. MFTs deployment phase 2.1 Objective Implement the MFTs for uncomplicated malaria in the health district of Kaya that is feasible, acceptable and achieve high coverage rate. 2.2 Drugs deployment Study ACTs and respective target populations: Artesunate-Pyronaridine for children less than five years of age Artemether-Lumefantrine for pregnant women Dihydroartemisinin-Piperaquine for individuals five years of age and above NB: Community case management of malaria using Artemether-Lumefantrine as per National Malaria Control Program recommendation. 2.3 Duration Twelve months including low and high malaria transmission seasons in the study area. Monitoring and evaluation phase 3.1 Objectives Assess the feasibility, the acceptability, the cost and the effects of the pilot MFTs pilot programme for uncomplicated malaria in the health district of Kaya. 3.2 Design Cross-sectional surveys using desk review, qualitative and quantitative research methods: Individual in-depth Interviews Focus group discussions Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation Health facility-based surveys for malaria-related morbidity and mortality, the availability and use of antimalarial drugs and malaria rapid diagnostic tests. Costs assessments. 3.3 Duration Four months. Post-evaluation phase 4.1 Objectives Communicating and disseminating the findings of the pilot implementation of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso; 4.2 Methodology Feedback meetings for reporting to local communities National workshop aiming at reporting the programme findings Final report to be submitted to the donor Oral presentations of findings at congresses, conferences, seminars and publication of findings in peer-reviewed scientific journals

Official Title
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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

Conditions
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Malaria

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Household survey Caregivers, adults, pregnant women Signed consent form Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children under-five<br>Uncomplicated malaria case in this group will be managed using Pyronaridine-Artesunate at health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case. | |
| Individuals five years of age and above<br>Uncomplicated malaria case in this group will be managed using Dihydoartemisinin-Piperaquine health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case. | |
| Pregnant women<br>Uncomplicated malaria case in this group will be managed using Artemether-Lumefantrin health facility level. This drug is registered in Burkina Faso for routine medical care for uncomplicated malaria case. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of favourable and unfavourable opinions from various profiles of informants about the MFT pilot program. | Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants. | From the formative phase to the end of drugs deployment: 18 months duration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of community resources people with favourable opinions to the MFTs pilot program. | Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants. | From the formative phase to the end of drugs deployment: 18 months duration. | 
| Proportion of community resources people with unfavourable opinions to the MFTs pilot program. | Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants. | From the formative phase to the end of drugs deployment: 18 months duration. | 
| Average number of monitoring visits performed per annum | Data will be obtained though the health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration. | 
| Average number of monitoring visits on which drugs stores have stock out of any dose of study ACTs per annum. | Data will be obtained though the health facility- based surveys. | 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. | Data will be obtained though the health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration. | 
| Proportion of febrile episode seen at health facility level. | Data will be obtained through health facility- based surveys using registers of Health Facilities (HF). | Through the MFTs deployment phase: 12 months of duration | 
| Proportion of febrile episode seen at health facility level (HFL) within 24 hours | Data will be obtained through health facility- based surveys using registers of HF. | Through the MFTs deployment phase: 12 months of duration | 
| Proportion of febrile episode seen at HFL within 24 hours and tested for parasitemia. | Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF. | 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 | Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF. | 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. | Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF. | 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. | Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF. | 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 | Household surveys (data will be collected in the community level through the KAP questionnaire). | During MFTs deployment phase at peak malaria season: 6 months of duration. | 
| Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis | Data will be obtained using the cost data collection forms through health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration. | 
| Cost per additional inappropriate antimalarial treatment avoided. | Data will be obtained using the cost data collection forms through health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration. | 
| The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis | Data will be obtained using the cost data collection forms through health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration | 
| The total cost per capita of intervention (provider perspective) | Data will be obtained using the cost data collection forms through health facility- based surveys. | Through the MFTs deployment phase: 12 months of duration | 
| The total cost per capita of intervention (societal perspective) | Data will be obtained using the cost data collection forms through household surveys (costing questionnaire administered at community level). | Through the MFTs deployment phase: 12 months of duration | 
| Cost to the HWs to participate to the MFTs strategy. | Data will be obtained using the cost data collection forms through at health facilities level. | Through the MFTs deployment phase: 12 months of duration. | 
| Proportion of episode of uncomplicated fever seen by HWs tested for malaria parasitemia. | Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF). | From the formative phase to the end of drugs deployment: 18 months duration. | 
| Proportion of uncomplicated fever episodes/malaria seen by HW, tested positive and treated with correct dose of ACT according to MFTs pilot program | Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF). | From the formative phase to the end of drugs deployment: 18 months duration. | 
| Proportion of febrile episodes treated with ACTs according to MFTs pilot programme by HWs provided with appropriate dosing advice | Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF). | 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. | Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF). | 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 | Household surveys before and during the MFTs deployment using KAP questionnaire administered at the community level. | 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. | Data will be obtained through the health facility- based surveys (data collected at the health facility level using the registers of HF). | Through the MFTs deployment phase: 12 months of duration. | 
| Mortality rate related to febrile episode/malaria before and during the pilot MFTs deployment. | Data will be collected through the Health and demographic surveillance system mortality data and health facility- based surveys (data collected at the health facility level using the registers of HF). | 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 | Household surveys using KAP questionnaire administered at the community level | 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 | Household surveys using KAP questionnaire administered at the community level. | 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 | Household survey using KAP questionnaire administered at the community level. | From the formative phase to the end of drugs deployment: 18 months duration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncomplicated malaria, Multiple First-lines Therapies, Artemisinin-based Combination Therapy, Acceptability, Feasability, Costs