Evaluation of Seasonal Malaria Chemoprevention in Kita

NCT ID: NCT02894294

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Malaria; Anemia

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Intervention district

implementation of the seasonal malaria chemoprevention

implementation of seasonal malaria chemoprevention

Intervention Type: 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.

Control district

no implementation of the seasonal malaria chemoprevention

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Bamako

OTHER

Sponsor Role: lead

Responsible Party

Alassane Dicko

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28797263 (View on PubMed)

Other Identifiers

FMPOS 2014-70

Identifier Type: -

Identifier Source: org_study_id