Evaluation of Seasonal Malaria Chemoprevention in Kita

NCT02894294 | Completed

• 1 other identifier: FMPOS 2014-70
• Study Type: observational
• Target: 1,162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria; Anemia

Keywords

malaria; chemoprevention; season; anemia; impact; coverage; children

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Confirmed malaria cases

  six months (July to December)

• Change in prevalence of anemia at baseline

  December 2014 (one month post last round of SMC)

• 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

  December 2014 (one month post last round of SMC)

Study Arms (2)

Intervention district

implementation of the seasonal malaria chemoprevention

Other: implementation of seasonal malaria chemoprevention

Control district

no implementation of the seasonal malaria chemoprevention

Interventions

implementation of seasonal malaria chemoprevention OTHER

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.

Intervention district

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 3-59 months of age

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bamako: lead
• United States Agency for International Development (USAID): collaborator
• Centers for Disease Control and Prevention: collaborator

Related Publications (1)

• 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.

  PMID: 28797263 DERIVED

MeSH Terms

Conditions

Malaria; Anemia; Tooth, Impacted

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 9, 2016
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share