Evaluation of Seasonal Malaria Chemoprevention in Kita

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Malaria
• Intervention / Treatment: Other: implementation of seasonal malaria chemoprevention

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 Type: Observational
• Enrollment (Actual): 1162

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged 3-59 months of age

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention district; implementation of the seasonal malaria chemoprevention	Other: implementation 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.
Control district; no implementation of the seasonal malaria chemoprevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	1-3 days post post first SMC dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed malaria cases	clinical malaria cases confirmed by rapid diagnostic test or blood smear in the selected health facilities	six months (July to December)
Change in prevalence of anemia at baseline	hemoglobin < 8 g/dL	December 2014 (one month post last round of SMC)
Adverse events	frequency of adverse events	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)	December 2014 (one month post last round of SMC)

Collaborators and Investigators

• Sponsor: University of Bamako
• Collaborators: United States Agency for International Development (USAID); Centers for Disease Control and Prevention

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 3, 2016
• First Posted (ESTIMATE): September 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: children; anemia; malaria; chemoprevention; coverage; impact; season
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: FMPOS 2014-70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon request to the Principal Investigator