MalariaNCT02894294
Evaluation of Seasonal Malaria Chemoprevention in Kita
An observational study of Malaria and Anemia, run by University of Bamako.
Trial summary
Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been… Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- What is being tested?
- implementation of seasonal malaria chemoprevention
- How many people
- 1,162 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2015
- How long will I take part?
- 6 Months
- 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 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3-59 months of age
Who may be able to join
- Children age 3-59 months
- Residence in the study areas
- Provision of inform consent
Who cannot join
- Age < 3 months or >= 60 months
- Not resident in the study areas
- No provision of inform consent
About this study
Official title: Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali
Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. Our evaluation used a pre-post design with cross-sectional surveys and abstraction of routine health information system data in an intervention district (Kita) where SMC was implemented through the health system, and a comparison district (Bafoulabe) where SMC was not implemented.
Read the detailed description
Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials (RCTs) have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease, and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. A pre-post design was used, with one intervention district, Kita where four rounds of SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine (SP+AQ) took place in August-November 2014, and one comparison district, Bafoulabe. Cross-sectional surveys were carried out in children aged 3-59 months from 30 randomly selected localities (15/district) at baseline and in follow-up to assess the impact of SMC on malaria parasitemia, fever, malaria illness, and anemia. The baseline survey was performed in July 2014 prior to the start of SMC implementation and the post-intervention (follow-up) surveys took place in December 2014. Blood samples were collected for thick/thin smears for malaria and hemoglobin measurement in two cross-sectional surveys, one prior to SMC in July 2014 and one after SMC in December 2014. The impact on malaria morbidity was assessed using routine data on confirmed malaria cases extracted from the registers by the research team in nine of the 47 community health centers in Kita and seven of the 24 health centers in Bafoulabe. Cross-sectional surveys were also carried out about 7 days after each of the four rounds of SMC to assess caregivers' adherence to the administration of SMC drugs and determine the frequency of adverse events in the intervention district of Kita. Coverage was assessed by cross-sectional in children 3-59 months in 30 randomly selected clusters in the district of Kita using interview of the caregivers and information on the SMC card in December 2014.
- Being tested
- implementation of seasonal malaria chemoprevention
- Keywords
- malaria, chemoprevention, season, anemia, impact, coverage, children
- Medical subject headings
- Malaria, Anemia, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of seasonal malaria chemopreventionOther
administration of therapeutic doses of antimalarials (Sulfadoxine-pyrimethamine [SP] + Amodiaquine [AQ]) at monthly intervals during the high malaria transmission season in children 3-59 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Intervention district | implementation of the seasonal malaria chemoprevention Receives: Other: implementation of seasonal malaria chemoprevention | |
| Control district | no implementation of the seasonal malaria chemoprevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coverage of SMC
Proportion of the children aged 3-59 months at the time of SMC who received the three days' treatment of SMC during that specific round
Measured: Four months (August to November in 2014)
Change in malaria infection from baseline
Malaria infection was defined as presence of malaria parasitemia by blood smear
Measured: December 2014 (one month post last round of SMC)
Change in prevalence of malaria illness from baseline
axillary temperature >= 37.5o C and blood smear positive for asexual forms of malaria parasites
Measured: December 2014 (one month post last round of SMC)
Adherence to SMC
proportion of children who received the second and third dose of AQ at home
Measured: 1-3 days post post first SMC dose
Secondary outcomes (4)
Confirmed malaria cases
clinical malaria cases confirmed by rapid diagnostic test or blood smear in the selected health facilities
Measured: six months (July to December)
Change in prevalence of anemia at baseline
hemoglobin < 8 g/dL
Measured: December 2014 (one month post last round of SMC)
Adverse events
frequency of adverse events
Measured: 7 days post SMC round in August, September, October and November in 2014
Change from baseline in frequency of molecular markers of resistance to SP and AQ
mutations at codons 51, 59, and 108 of the dhfr gene, 437 and 540 of the dhps gene, mutations at codon 76 in the P. falciparum chloroquine transporter gene (pfcrt), and at codon 86 of the P. falciparum multidrug resistance gene one (pfmdr1)
Measured: December 2014 (one month post last round of SMC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,162 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Bamako
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Alassane Dicko, University of Bamako
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894294
- Sponsor's protocol ID
- FMPOS 2014-70
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available upon request to the Principal Investigator
Publications
Diawara F, Steinhardt LC, Mahamar A, Traore T, Kone DT, Diawara H, Kamate B, Kone D, Diallo M, Sadou A, Mihigo J, Sagara I, Djimde AA, Eckert E, Dicko A. Measuring the impact of seasonal malaria chemoprevention as part of routine malaria control in Kita, Mali. Malar J. 2017 Aug 10;16(1):325. doi: 10.1186/s12936-017-1974-x.
PubMed 28797263
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali
- ClinicalTrials.gov ID
- NCT02894294
- Acronym / sponsor ID
- FMPOS 2014-70
- Keywords
- malaria, chemoprevention, season, anemia, impact, coverage, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- University of BamakoUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Centers for Disease Control and Prevention
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2016 (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.
Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. Our evaluation used a pre-post design with cross-sectional surveys and abstraction of routine health information system data in an intervention district (Kita) where SMC was implemented through the health system, and a comparison district (Bafoulabe) where SMC was not implemented.
Detailed description
Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although randomized controlled trials (RCTs) have shown SMC to be highly effective, evidence and experience from routine implementation of SMC has been lacking. For these reasons, we conducted a comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection and disease, and anemia when delivered through routine programs using existing community health workers in the Kayes region in Mali. A pre-post design was used, with one intervention district, Kita where four rounds of SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine (SP+AQ) took place in August-November 2014, and one comparison district, Bafoulabe. Cross-sectional surveys were carried out in children aged 3-59 months from 30 randomly selected localities (15/district) at baseline and in follow-up to assess the impact of SMC on malaria parasitemia, fever, malaria illness, and anemia. The baseline survey was performed in July 2014 prior to the start of SMC implementation and the post-intervention (follow-up) surveys took place in December 2014. Blood samples were collected for thick/thin smears for malaria and hemoglobin measurement in two cross-sectional surveys, one prior to SMC in July 2014 and one after SMC in December 2014. The impact on malaria morbidity was assessed using routine data on confirmed malaria cases extracted from the registers by the research team in nine of the 47 community health centers in Kita and seven of the 24 health centers in Bafoulabe. Cross-sectional surveys were also carried out about 7 days after each of the four rounds of SMC to assess caregivers' adherence to the administration of SMC drugs and determine the frequency of adverse events in the intervention district of Kita. Coverage was assessed by cross-sectional in children 3-59 months in 30 randomly selected clusters in the district of Kita using interview of the caregivers and information on the SMC card in December 2014.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention district | – | Other: implementation of seasonal malaria chemopreventionimplementation of the seasonal malaria chemoprevention |
| Control district | – | –no implementation of the seasonal malaria chemoprevention |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3-59 months of age
Key inclusion criteria (3 listed)
- Children age 3-59 months
- Residence in the study areas
- Provision of inform consent
Key exclusion criteria (3 listed)
- Age < 3 months or >= 60 months
- Not resident in the study areas
- No provision of inform consent
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 |
|---|---|---|
| implementation of seasonal malaria chemopreventionadministration of therapeutic doses of antimalarials (Sulfadoxine-pyrimethamine [SP] + Amodiaquine [AQ]) at monthly intervals during the high malaria transmission season in children 3-59 months of age. | Other | Intervention district |
Primary outcome
Coverage of SMC
Time frame: Four months (August to November in 2014)
Proportion of the children aged 3-59 months at the time of SMC who received the three days' treatment of SMC during that specific round
Change in malaria infection from baseline
Time frame: December 2014 (one month post last round of SMC)
Malaria infection was defined as presence of malaria parasitemia by blood smear
Change in prevalence of malaria illness from baseline
Time frame: December 2014 (one month post last round of SMC)
axillary temperature >= 37.5o C and blood smear positive for asexual forms of malaria parasites
Adherence to SMC
Time frame: 1-3 days post post first SMC dose
proportion of children who received the second and third dose of AQ at home
4 secondary outcomes
Confirmed malaria cases
Time frame: six months (July to December)
Change in prevalence of anemia at baseline
Time frame: December 2014 (one month post last round of SMC)
Adverse events
Time frame: 7 days post SMC round in August, September, October and November in 2014
Change from baseline in frequency of molecular markers of resistance to SP and AQ
Time frame: December 2014 (one month post last round of SMC)
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 14 Sep 2016.
- Derived from this study: PubMed 28797263Diawara F, Steinhardt LC, Mahamar A, Traore T, Kone DT, Diawara H, Kamate B, Kone D, Diallo M, Sadou A, Mihigo J, Sagara I, Djimde AA, Eckert E, Dicko A. Measuring the impact of seasonal malaria chemoprevention as part of routine malaria control in Kita, Mali. Malar J. 2017 Aug 10;16(1):325. doi: 10.1186/s12936-017-1974-x.
- Individual participant dataSharing planned: Yes. Data will be available upon request to the Principal Investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Anemia, run by University of Bamako.
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 3 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Coverage of SMC (time frame: Four months (August to November in 2014)). The study lists 4 primary outcomes in all. 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 NCT02894294, which also lists 1 linked publication.
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 14 Sep 2016.