MalariaPhase 4NCT02536222
Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
A Phase 4 study testing Case investigation of malaria passively detected cases with FT/FDA in people with Malaria, run by PATH at 1 site in Senegal.
Trial summary
The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the… Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Case investigation of malaria passively detected cases with FT/FDA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,379 participants
- Where
- 1 siteSenegal
- Study dates
- Sep 2015to Jul 2016
- Phase
- Phase 4
- 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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signs the informed consent form
- Aged more than 2 months
- Resident member of the selected household
- Does not present any severity symptoms
Who cannot join
- Refuses to sign the informed consent form
- Aged less than 2 months
- Is not a resident member of the selected household
- Presents severity symptoms
Trial locations and contacts
1 site in 1 country.
Senegal1 site
six health posts in Kanel, Linguère and Ranérou districts
Oudallaye, Mbem-Mbem, Salalatou, Doundé, Nianghana, Gassane, Louga and Matam
About this study
The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics but with a slightly lower incidence rate were chosen as controls. It will be implemented in all villages in the six intervention health posts and it will consist of investigating all passively detected cases (index cases) and conducting focal test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a positive RDT. All household members in households with a positive RDT will be treated, regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after comparison and compared to the change in the control health posts and the operational aspects will be assessed for subsequent scale up.
Read the detailed description
- Introduction: During the last decade, 34 countries that have set the objective of freeing themselves from malaria, have obtained remarkable success in reducing the burden of the disease to very low levels that could represent a starting point to elimination programs leading to complete elimination. This remarkable success led several other countries to develop malaria elimination programs supported by the Global Malaria Action Plan of the Roll Back Malaria Partnership: "For a malaria-free world" which has for objective to eliminate malaria in at least 35 endemic countries by 2030. However, the transition from a strategy of malaria control toward a program centered on elimination has not yet been documented. PATH collaborates with the PNLP and regional and district health authorities to produce evidence that allows to make decisions on a model of reduction of malaria transmission in health posts. To that effect, a set of strategies will be put in place and evaluated to efficiently identify and eliminate malaria infections. Thus, zones freed from the disease will be documented. In Senegal, the epidemiological profile of malaria presents the conditions for disease elimination in the North and North-central areas of the country. Since 2012, the National Malaria control program, with support from PATH, has the objective of reducing Plasmodium falciparum transmission in several geographical areas of Saint-Louis, Matam and Louga regions.
- Goal and Objective: The goal of the proposed work is to contribute to the national effort of malaria pre-elimination in Senegal, in line with the National Malaria control program's 2014-2018 strategic framework. The main objective is to strengthen the implementation of malaria case investigation in Linguère, Ranérou and Kanel districts, to evaluate operational aspects of scaling up the strategy and to evaluate the impact on malaria transmission to guide evidence-based decision-making.
- Sites: The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that have been chosen on the basis of the malaria incidence rate, the wide differences of transmission between villages in the health post catchment areas, their proximity and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2015, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics were chosen as controls.
- Study design A quasi-experimental study design will be used to evaluate the impact of the intervention. The incidence of malaria cases and the prevalence of parasitemia will be compared before and after the intervention and between the intervention and the control areas (difference-in-differences). Cross-sectional surveys will be conducted to estimate the parasitemia prevalence with RDT at the beginning and at the end of the high transmission season in intervention and in control areas.
- Methodology Systematic malaria case investigation will be performed in all villages of the 6 intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker (DSDOM)) will visit the household of the index case and the 5 closest households (in a 100 m radius) and will test by RDT all the individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with dihydro-artemisinin-piperaquine (DHA-PQ)
- Duration:
The study is scheduled to last one year.(July 2015-June 2016).
- Conditions
- Malaria
- Being tested
- Case investigation of malaria passively detected cases with FT/FDA
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case investigation of malaria passively detected cases with FT/FDAOther
Systematic reactive malaria case investigation will be performed in all villages of the six intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker) will visit the household of the index case and the five closest households (in a 100 meter radius) and will test by RDT all the consenting individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with DHAP through which all members will be treated.
| Study group | Role | What they receive |
|---|---|---|
| Reactive case investigation : FT/FDA with DHA-PQ | Experimental | All consenting household members eligible to receive DHA-PQ and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHA-PQ. If no one in the household tests RDT positive then no one in the household will receive DHA-PQ. Receives: Other: Case investigation of malaria passively detected cases with FT/FDA |
| No Intervention: Standard of Care (Control) | No intervention | The standard of care arm will have the standard of care offered by the Ministry of Health which applies to all arms. This includes available mosquito net coverage and passive case detection of individuals seeking treatment from a health provider at a health post or community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of passively detected malaria cases
Incidence of passively detected RDT-confirmed malaria cases among individuals older than 2 months (at the health posts or by community health workers), collected through the rapid reporting system already in place. Every week, health facility workers submit basic information on malaria burden, that is entered into DHIS2 (district health information system) at the district level. The quality of the rapid reporting system will be monitored through routine data quality audits (comparing health post registers with submitted data) and continuous monitoring of the data submitted to DHIS2. The estimated enrollment is 30 000 individuals. A comparison before and after the intervention and between interventions and control villages will be done using a difference-in-difference analysis.
Measured: one malaria transmission season (up to 5 months)
Secondary outcomes (1)
Prevalence of Plasmodium falciparum parasitaemia
Prevalence of infection by RDT/polymerase chain reaction (PCR): will be measured during cross-sectional surveys at the beginning and at the end of the transmission season. 16,000 participants are expected to take part in both cross sectional surveys. The prevalence by PCR will only be available later when the laboratory results become available. A comparison before and after the intervention and between interventions and control villages will be done using a difference-in-difference analysis.
Measured: At the begining (one month after the first rain) and the end (one month after the last rain) of the transmission season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Program, Regional and district health authorities of Matam and Louga regions and Kanel Ranerou and Linguere districts of Senegal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536222
- Sponsor's protocol ID
- 762488-1
- Status last verified
- Sep 2016
- First submitted
- 5 Aug 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
- ClinicalTrials.gov ID
- NCT02536222
- Acronym / sponsor ID
- 762488-1
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,379 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- National Malaria Control Program, Regional and district health authorities of Matam and Louga regions and Kanel Ranerou and Linguere districts of Senegal
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- 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.
The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics but with a slightly lower incidence rate were chosen as controls. It will be implemented in all villages in the six intervention health posts and it will consist of investigating all passively detected cases (index cases) and conducting focal test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a positive RDT. All household members in households with a positive RDT will be treated, regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after comparison and compared to the change in the control health posts and the operational aspects will be assessed for subsequent scale up.
Detailed description
- Introduction: During the last decade, 34 countries that have set the objective of freeing themselves from malaria, have obtained remarkable success in reducing the burden of the disease to very low levels that could represent a starting point to elimination programs leading to complete elimination. This remarkable success led several other countries to develop malaria elimination programs supported by the Global Malaria Action Plan of the Roll Back Malaria Partnership: "For a malaria-free world" which has for objective to eliminate malaria in at least 35 endemic countries by 2030. However, the transition from a strategy of malaria control toward a program centered on elimination has not yet been documented. PATH collaborates with the PNLP and regional and district health authorities to produce evidence that allows to make decisions on a model of reduction of malaria transmission in health posts. To that effect, a set of strategies will be put in place and evaluated to efficiently identify and eliminate malaria infections. Thus, zones freed from the disease will be documented. In Senegal, the epidemiological profile of malaria presents the conditions for disease elimination in the North and North-central areas of the country. Since 2012, the National Malaria control program, with support from PATH, has the objective of reducing Plasmodium falciparum transmission in several geographical areas of Saint-Louis, Matam and Louga regions.
- Goal and Objective: The goal of the proposed work is to contribute to the national effort of malaria pre-elimination in Senegal, in line with the National Malaria control program's 2014-2018 strategic framework. The main objective is to strengthen the implementation of malaria case investigation in Linguère, Ranérou and Kanel districts, to evaluate operational aspects of scaling up the strategy and to evaluate the impact on malaria transmission to guide evidence-based decision-making.
- Sites: The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that have been chosen on the basis of the malaria incidence rate, the wide differences of transmission between villages in the health post catchment areas, their proximity and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2015, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics were chosen as controls.
- Study design A quasi-experimental study design will be used to evaluate the impact of the intervention. The incidence of malaria cases and the prevalence of parasitemia will be compared before and after the intervention and between the intervention and the control areas (difference-in-differences). Cross-sectional surveys will be conducted to estimate the parasitemia prevalence with RDT at the beginning and at the end of the high transmission season in intervention and in control areas.
- Methodology Systematic malaria case investigation will be performed in all villages of the 6 intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker (DSDOM)) will visit the household of the index case and the 5 closest households (in a 100 m radius) and will test by RDT all the individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with dihydro-artemisinin-piperaquine (DHA-PQ)
- Duration:
The study is scheduled to last one year.(July 2015-June 2016).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive case investigation : FT/FDA with DHA-PQ | Experimental | Other: Case investigation of malaria passively detected cases with FT/FDAAll consenting household members eligible to receive DHA-PQ and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHA-PQ. If no one in the household tests RDT positive then no one in the household will receive DHA-PQ. |
| No Intervention: Standard of Care (Control) | No intervention | –The standard of care arm will have the standard of care offered by the Ministry of Health which applies to all arms. This includes available mosquito net coverage and passive case detection of individuals seeking treatment from a health provider at a health post or community. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signs the informed consent form
- Aged more than 2 months
- Resident member of the selected household
- Does not present any severity symptoms
Key exclusion criteria (4 listed)
- Refuses to sign the informed consent form
- Aged less than 2 months
- Is not a resident member of the selected household
- Presents severity symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case investigation of malaria passively detected cases with FT/FDASystematic reactive malaria case investigation will be performed in all villages of the six intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker) will visit the household of the index case and the five closest households (in a 100 meter radius) and will test by RDT all the consenting individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with DHAP through which all members will be treated. | Other | Reactive case investigation : FT/FDA with DHA-PQ |
Primary outcome
Incidence of passively detected malaria cases
Time frame: one malaria transmission season (up to 5 months)
Incidence of passively detected RDT-confirmed malaria cases among individuals older than 2 months (at the health posts or by community health workers), collected through the rapid reporting system already in place. Every week, health facility workers submit basic information on malaria burden, that is entered into DHIS2 (district health information system) at the district level. The quality of the rapid reporting system will be monitored through routine data quality audits (comparing health post registers with submitted data) and continuous monitoring of the data submitted to DHIS2. The estimated enrollment is 30 000 individuals. A comparison before and after the intervention and between interventions and control villages will be done using a difference-in-difference analysis.
1 secondary outcome
Prevalence of Plasmodium falciparum parasitaemia
Time frame: At the begining (one month after the first rain) and the end (one month after the last rain) of the transmission season
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 15 Sep 2016.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Case investigation of malaria passively detected cases with FT/FDA in people with Malaria, run by PATH at 1 site in Senegal.
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 4 inclusion and 4 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 15 Sep 2016. 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 Senegal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of passively detected malaria cases (time frame: one malaria transmission season (up to 5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2016.