Anemia Clinical Trial
Official title:
Measuring the Impact of Seasonal Malaria Chemoprevention as Part of Routine Malaria Control in Kita, Mali
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] |
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.
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 |
Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Bamako | Centers for Disease Control and Prevention, United States Agency for International Development (USAID) |
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 |
Status | Clinical Trial | Phase | |
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