Clinical trial NCT02894294: Evaluation of Seasonal Malaria Chemoprevention in Kita
Official title: Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Anemia
Keywords: malaria
chemoprevention
season
anemia
impact
coverage
children
Lead sponsor: University of Bamako
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Centers for Disease Control and Prevention
First posted: 2016-09-09
Enrollment: 1162
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 3-59 months of age

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.

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

Primary outcomes:
measure: Coverage of SMC
timeFrame: Four months (August to November in 2014)
measure: Change in malaria infection from baseline
timeFrame: December 2014 (one month post last round of SMC)
measure: Change in prevalence of malaria illness from baseline
timeFrame: December 2014 (one month post last round of SMC)
measure: Adherence to SMC
timeFrame: 1-3 days post post first SMC dose
Secondary outcomes:
measure: Confirmed malaria cases
timeFrame: six months (July to December)
measure: Change in prevalence of anemia at baseline
timeFrame: December 2014 (one month post last round of SMC)
measure: Adverse events
timeFrame: 7 days post SMC round in August, September, October and November in 2014
measure: Change from baseline in frequency of molecular markers of resistance to SP and AQ
timeFrame: December 2014 (one month post last round of SMC)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.