Skip to content

Evaluation of Seasonal Malaria Chemoprevention in Kita

Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02894294
Enrollment
1162
Registered
2016-09-09
Start date
2014-07-31
Completion date
2015-06-30
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Malaria

Keywords

malaria, chemoprevention, season, anemia, impact, coverage, children

Brief 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 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.

Interventions

OTHERimplementation of seasonal malaria chemoprevention

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.

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
Centers for Disease Control and Prevention
CollaboratorFED
University of Bamako
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Months to 59 Months
Healthy volunteers
Yes

Inclusion criteria

* Children age 3-59 months * Residence in the study areas * Provision of inform consent

Exclusion criteria

* Age \< 3 months or \>= 60 months * Not resident in the study areas * No provision of inform consent

Design outcomes

Primary

MeasureTime frameDescription
Adherence to SMC1-3 days post post first SMC doseproportion of children who received the second and third dose of AQ at home
Coverage of SMCFour 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 baselineDecember 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 baselineDecember 2014 (one month post last round of SMC)axillary temperature \>= 37.5o C and blood smear positive for asexual forms of malaria parasites

Secondary

MeasureTime frameDescription
Confirmed malaria casessix months (July to December)clinical malaria cases confirmed by rapid diagnostic test or blood smear in the selected health facilities
Change in prevalence of anemia at baselineDecember 2014 (one month post last round of SMC)hemoglobin \< 8 g/dL
Adverse events7 days post SMC round in August, September, October and November in 2014frequency of adverse events
Change from baseline in frequency of molecular markers of resistance to SP and AQDecember 2014 (one month post last round of SMC)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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026