MalariaNCT04265573
Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies
An observational study of Malaria, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 150,000 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 10 Nov 2018to 25 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The target populations for the deployment of the MFTs for uncomplicated malaria are: children less than five years of age, pregnant women, individuals five years of age and above.
Who may be able to join
- Household survey
- Caregivers, adults, pregnant women
- Signed consent form
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Conditions
- Malaria
- Keywords
- Uncomplicated malaria, Multiple First-lines Therapies, Artemisinin-based Combination Therapy, Acceptability, Feasability, Costs
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the formative phase to the end of drugs deployment: 18 months duration.
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: From the formative phase to the end of drugs deployment: 18 months duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start10 Nov 2018
- Primary completion1 Dec 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe de Recherche Action en Sante
- Sponsor type
- University, hospital or other
- Collaborators
- Medicines for Malaria Venture, National Malaria Control Program, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Mohamadou Siribié, MD, PhD, Principal investigator, Groupe de Recherche Action en SanteAndré-Marie Tchouatieu, MD, Principal investigator, Medicine for Malaria Venture (MMV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265573
- Sponsor's protocol ID
- MFTs-ACTs-BF (PO17/01110)
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27022739Boni 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.
PubMed 18780786Kabore 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.
PubMed 35637506Siribie 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.
PubMed 33589447
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04265573
- Acronym / sponsor ID
- MFTs-ACTs-BF (PO17/01110)
- Conditions
- Malaria
- Keywords
- Uncomplicated malaria, Multiple First-lines Therapies, Artemisinin-based Combination Therapy, Acceptability, Feasability, Costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Groupe de Recherche Action en SanteUniversity, hospital or other
- Collaborators
- Medicines for Malaria Venture, National Malaria Control Program, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target populations for the deployment of the MFTs for uncomplicated malaria are: children less than five years of age, pregnant women, individuals five years of age and above.
Key inclusion criteria (3 listed)
- Household survey
- Caregivers, adults, pregnant women
- Signed consent form
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants.
28 secondary outcomes
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.
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.
Average number of monitoring visits performed per annum
Time frame: 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.
Time frame: 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.
Time frame: Through the MFTs deployment phase: 12 months of duration.
Proportion of febrile episode seen at health facility level.
Time frame: Through the MFTs deployment phase: 12 months of duration
Proportion of febrile episode seen at health facility level (HFL) within 24 hours
Time frame: 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.
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.
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.
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.
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.
Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis
Time frame: Through the MFTs deployment phase: 12 months of duration.
Cost per additional inappropriate antimalarial treatment avoided.
Time frame: Through the MFTs deployment phase: 12 months of duration.
The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis
Time frame: Through the MFTs deployment phase: 12 months of duration
The total cost per capita of intervention (provider perspective)
Time frame: Through the MFTs deployment phase: 12 months of duration
The total cost per capita of intervention (societal perspective)
Time frame: Through the MFTs deployment phase: 12 months of duration
Cost to the HWs to participate to the MFTs strategy.
Time frame: Through the MFTs deployment phase: 12 months of duration.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Results publication: PubMed 27022739Boni 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.
- Results publication: PubMed 18780786Boni 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.
- Derived from this study: PubMed 35637506Kabore 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.
- Derived from this study: PubMed 33589447Siribie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamadou Siribié, MD, PhD principal investigator
Groupe de Recherche Action en Sante
André-Marie Tchouatieu, MD principal investigator
Medicine for Malaria Venture (MMV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265573, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.