- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265573
Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies
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
Study Overview
Status
Conditions
Detailed Description
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ouagadougou, Burkina Faso
- Groupe de Recherche Action en Santé
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Household survey
- Caregivers, adults, pregnant women
- Signed consent form
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children under-five
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
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.
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Pregnant women
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?
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.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants.
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From the formative phase to the end of drugs deployment: 18 months duration.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of community resources people with favourable opinions to the MFTs pilot program.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
|
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.
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Proportion of community resources people with unfavourable opinions to the MFTs pilot program.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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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
Time Frame: Through the MFTs deployment phase: 12 months of duration.
|
Data will be obtained though the health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration.
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Average number of monitoring visits on which drugs stores have stock out of any dose of study ACTs per annum.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained though the health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration.
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Average number of monitoring visits on which health facilities have stock out of mRDTs per annum.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained though the health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration.
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Proportion of febrile episode seen at health facility level.
Time Frame: Through the MFTs deployment phase: 12 months of duration
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Data will be obtained through health facility- based surveys using registers of Health Facilities (HF).
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Through the MFTs deployment phase: 12 months of duration
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Proportion of febrile episode seen at health facility level (HFL) within 24 hours
Time Frame: Through the MFTs deployment phase: 12 months of duration
|
Data will be obtained through health facility- based surveys using registers of HF.
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Through the MFTs deployment phase: 12 months of duration
|
Proportion of febrile episode seen at HFL within 24 hours and tested for parasitemia.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Malaria diagnosis will done using malaria rapid diagnosis test (mRDT).
Data will be obtained through health facility- based surveys using registers of HF.
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Through the MFTs deployment phase: 12 months of duration.
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Proportion of febrile episode seen at HFL within 24 hours with positive diagnostic test who were given ACT according to the MFTs strategy
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Malaria diagnosis will done using malaria rapid diagnosis test (mRDT).
Data will be obtained through health facility- based surveys using registers of HF.
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Through the MFTs deployment phase: 12 months of duration.
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Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who did not received any antimalarial.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Malaria diagnosis will done using malaria rapid diagnosis test (mRDT).
Data will be obtained through health facility- based surveys using registers of HF.
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Through the MFTs deployment phase: 12 months of duration.
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Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who received an ACT.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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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.
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Proportion of febrile episodes treated with ACTs adhering to ACT treatment schedule (timing and doses) by HWs according to MFTs strategy
Time Frame: During MFTs deployment phase at peak malaria season: 6 months of duration.
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Household surveys (data will be collected in the community level through the KAP questionnaire).
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During MFTs deployment phase at peak malaria season: 6 months of duration.
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Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained using the cost data collection forms through health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration.
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Cost per additional inappropriate antimalarial treatment avoided.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained using the cost data collection forms through health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration.
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The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis
Time Frame: Through the MFTs deployment phase: 12 months of duration
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Data will be obtained using the cost data collection forms through health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration
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The total cost per capita of intervention (provider perspective)
Time Frame: Through the MFTs deployment phase: 12 months of duration
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Data will be obtained using the cost data collection forms through health facility- based surveys.
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Through the MFTs deployment phase: 12 months of duration
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The total cost per capita of intervention (societal perspective)
Time Frame: Through the MFTs deployment phase: 12 months of duration
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Data will be obtained using the cost data collection forms through household surveys (costing questionnaire administered at community level).
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Through the MFTs deployment phase: 12 months of duration
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Cost to the HWs to participate to the MFTs strategy.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained using the cost data collection forms through at health facilities level.
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Through the MFTs deployment phase: 12 months of duration.
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Proportion of episode of uncomplicated fever seen by HWs tested for malaria parasitemia.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).
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From the formative phase to the end of drugs deployment: 18 months duration.
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Proportion of uncomplicated fever episodes/malaria seen by HW, tested positive and treated with correct dose of ACT according to MFTs pilot program
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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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.
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Proportion of febrile episodes treated with ACTs according to MFTs pilot programme by HWs provided with appropriate dosing advice
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
|
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.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
|
Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).
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From the formative phase to the end of drugs deployment: 18 months duration.
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Incidence of uncomplicated febrile episode/malaria within 4 weeks preceding the surveys
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Household surveys before and during the MFTs deployment using KAP questionnaire administered at the community level.
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From the formative phase to the end of drugs deployment: 18 months duration.
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Proportion of uncomplicated febrile episode/malaria seen at health facility level before and during the MFTs deployment in the study area.
Time Frame: Through the MFTs deployment phase: 12 months of duration.
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Data will be obtained through the health facility- based surveys (data collected at the health facility level using the registers of HF).
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Through the MFTs deployment phase: 12 months of duration.
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Mortality rate related to febrile episode/malaria before and during the pilot MFTs deployment.
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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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).
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From the formative phase to the end of drugs deployment: 18 months duration.
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Proportion of individuals with fever in the last four weeks for whom advice or treatment was sought
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Household surveys using KAP questionnaire administered at the community level
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From the formative phase to the end of drugs deployment: 18 months duration.
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Proportion of individuals with fever in the last four week who sought treatment at HFL within 24 hours
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Household surveys using KAP questionnaire administered at the community level.
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From the formative phase to the end of drugs deployment: 18 months duration.
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Source of advice or care for those suffering from fever in the last four weeks
Time Frame: From the formative phase to the end of drugs deployment: 18 months duration.
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Household survey using KAP questionnaire administered at the community level.
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From the formative phase to the end of drugs deployment: 18 months duration.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mohamadou Siribié, MD, PhD, Groupe de Recherche Action en Sante (GRAS)
- Principal Investigator: André-Marie Tchouatieu, MD, Medicine for Malaria Venture (MMV)
Publications and helpful links
General Publications
- Boni MF, White NJ, Baird JK. The Community As the Patient in Malaria-Endemic Areas: Preempting Drug Resistance with Multiple First-Line Therapies. PLoS Med. 2016 Mar 29;13(3):e1001984. doi: 10.1371/journal.pmed.1001984. eCollection 2016 Mar.
- Boni MF, Smith DL, Laxminarayan R. Benefits of using multiple first-line therapies against malaria. Proc Natl Acad Sci U S A. 2008 Sep 16;105(37):14216-21. doi: 10.1073/pnas.0804628105. Epub 2008 Sep 9.
- Kabore JMT, Siribie M, Hien D, Soulama I, Barry N, Nombre Y, Dianda F, Baguiya A, Tiono AB, Burri C, Tchouatieu AM, Sirima SB. Attitudes, practices, and determinants of community care-seeking behaviours for fever/malaria episodes in the context of the implementation of multiple first-line therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso. Malar J. 2022 May 30;21(1):155. doi: 10.1186/s12936-022-04180-z.
- Siribie M, Tchouatieu AM, Soulama I, Kabore JMT, Nombre Y, Hien D, Kiba Koumare A, Barry N, Baguiya A, Hema A, Dianda F, Savadogo Y, Kouanda S, Tiono AB, Sirima SB. Protocol for a quasi-experimental study to assess the feasibility, acceptability and costs of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the Kaya health district, Burkina Faso. BMJ Open. 2021 Feb 15;11(2):e040220. doi: 10.1136/bmjopen-2020-040220.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFTs-ACTs-BF (PO17/01110)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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