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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894294
Other study ID # FMPOS 2014-70
Secondary ID
Status Completed
Phase N/A
First received August 26, 2016
Last updated September 13, 2016
Start date July 2014
Est. completion date June 2015

Study information

Verified date September 2016
Source University of Bamako
Contact n/a
Is FDA regulated No
Health authority Mali: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1162
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 59 Months
Eligibility 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 Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Bamako Centers for Disease Control and Prevention, United States Agency for International Development (USAID)

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Primary 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) No
Primary 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) Yes
Primary 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 No
Secondary Confirmed malaria cases clinical malaria cases confirmed by rapid diagnostic test or blood smear in the selected health facilities six months (July to December) No
Secondary Change in prevalence of anemia at baseline hemoglobin < 8 g/dL December 2014 (one month post last round of SMC) Yes
Secondary Adverse events frequency of adverse events 7 days post SMC round in August, September, October and November in 2014 Yes
Secondary 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) No
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