Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery
SMC
Optimal Delivery of Seasonal Malaria Chemoprevention and Its Effects on the Acquisition of Malaria Immunity
1 other identifier
interventional
10,000
1 country
1
Brief Summary
Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy for malaria control in countries with seasonal malaria transmission such as Mali in March 2012. The goals are to identify the most effective method to deliver SMC, and to obtain more information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC delivery; 2) to compare quantitative measures of immunity in children who do and do not receive SMC. A cluster-randomized design will be sued. The target population will be children aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The optimal mode of delivery will be selected based on the SMC coverage during the first year, and will then be implemented in villages of two additional sub-districts. Villages in these two newly selected sub-districts will be randomized in two groups. Children in the first group will received three rounds of SMC and those in the second group will receive four rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of clinical malaria as measured by passive surveillance. In Year 3, children in the selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. A survey will be conducted collect data on mortality and hospital admission and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 29, 2015
CompletedFirst Posted
Study publicly available on registry
January 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 2, 2018
April 1, 2018
4.3 years
December 29, 2015
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Coverage of SMC
SMC coverage will be defined as proportion of the children who have received the three treatments doses at each of the three rounds of SMC.
1-5 weeks after last round of SMC in Year1
Incidence of clinical malaria in Year 2
Clinical malaria defined as signs and symptoms suggestive of malaria with positive RDT and/or positive blood smear.
up to 4 weeks after the last round of SMC
Mortality rate
death
1, 2, 3, 4 years of the intervention
Hospital admission
Hospitalization
1, 2, 3, 4 years of the intervention
Secondary Outcomes (6)
malaria parasitemia
one week before the first round of SMC and 4-6 weeks after the last round of SMC
moderate anemia
one week before the first round of SMC and 4-6 weeks after the last round of SMC
immune response to malaria parasite
one week before the first round of SMC and 4-6 weeks after the last round of SMC
molecular markers of resistance to SP + AQ
one week before the first round of SMC and 4-6 weeks after the last round of SMC
nutritional status
one week before the first round of SMC and 4-6 weeks after the last round of SMC
- +1 more secondary outcomes
Study Arms (4)
FPD+NDOT
OTHERFixed-point delivery (FPD) combined with non directly observed treatment (NDOT)
FPD+DOT
OTHERFixed-point delivery (FPD) combined with directly observed treatment (DOT)
DDD+NDOT
OTHERdoor-to-door delivery (DDD) combined with non directly observed treatment (NDOT)
DDD+DOT
OTHERdoor-to-door delivery (DDD) combined with directly observed treatment (NDOT)
Interventions
Eligibility Criteria
You may qualify if:
- Age \>= 3 months \& \< 60 months
You may not qualify if:
- severe, chronic illness
- known allergy to one of the study drugs (SP or AQ)
- known HIV positive subjects using Cotrimoxazole.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malaria Research and Training Center
Bamako, Mali
Related Publications (2)
Issiaka D, Barry A, Traore T, Diarra B, Cook D, Keita M, Sagara I, Duffy P, Fried M, Dicko A. Impact of seasonal malaria chemoprevention on hospital admissions and mortality in children under 5 years of age in Ouelessebougou, Mali. Malar J. 2020 Mar 3;19(1):103. doi: 10.1186/s12936-020-03175-y.
PMID: 32126989DERIVEDBarry A, Issiaka D, Traore T, Mahamar A, Diarra B, Sagara I, Kone D, Doumbo OK, Duffy P, Fried M, Dicko A. Optimal mode for delivery of seasonal malaria chemoprevention in Ouelessebougou, Mali: A cluster randomized trial. PLoS One. 2018 Mar 5;13(3):e0193296. doi: 10.1371/journal.pone.0193296. eCollection 2018.
PMID: 29505578DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2015
First Posted
January 5, 2016
Study Start
August 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
May 2, 2018
Record last verified: 2018-04