Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery

NCT ID: NCT02646410

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-12-31

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.

Detailed Description

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 strategy is a highly cost-effective approach to reduce childhood mortality in these areas. Despite the huge benefit of the SMC on malaria infection and disease, the optimal approach to deliver SMC remains to be determined and there is no data on the long term effect of this strategy on the development of immunity to malaria. While fixed-point delivery (FPD) combined with non directly observed treatment (NDOT) by community health workers is attractive for the SMC implementation, it is need to be evaluated and compared to other mode of delivery. The objectives are to identify the most effective method to deliver SMC, and to obtain information on the long term impact of SMC on malaria immunity. Specifically, i) 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; ii) to compare quantitative measures of immunity in children who do and do not receive SMC over a three year period.

The design is a cluster-randomized trial over three years. The target population is children aged 3-59 months old living 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. Children in the four sub-districts selected in Year 1 will continue to receive three rounds of SMC in Year 2 using the optimal mode of delivery. In Year 3, children in the randomly selected sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. Immune responses will be measured and compared between the children receiving SMC to a cohort of children not receiving SMC, to assess the impact of SMC on key antimalarial antibody responses over the three year period using cross-sectional surveys at the beginning and the end of the transmission season.

In Year 3, 4 and 5 surveys will be conducted to collect data on mortality and hospital admissions and compare these outcomes in areas where SMC was implemented and areas where SMC was not implemented.

Conditions

Malaria; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FPD+NDOT

Fixed-point delivery (FPD) combined with non directly observed treatment (NDOT)

Group Type: OTHER

FPD+NDOT

Intervention Type: OTHER

FPD+DOT

Fixed-point delivery (FPD) combined with directly observed treatment (DOT)

Group Type: OTHER

FPD+DOT

Intervention Type: OTHER

DDD+NDOT

door-to-door delivery (DDD) combined with non directly observed treatment (NDOT)

Group Type: OTHER

DDD+NDOT

Intervention Type: OTHER

Door to door delivery + non directly observed treatment

DDD+DOT

door-to-door delivery (DDD) combined with directly observed treatment (NDOT)

Group Type: OTHER

DDD+DOT

Intervention Type: OTHER

Door to door delivery + directly observed treatment

Interventions

FPD+NDOT

Intervention Type: OTHER

FPD+DOT

Intervention Type: OTHER

DDD+NDOT

Door to door delivery + non directly observed treatment

Intervention Type: OTHER

DDD+DOT

Door to door delivery + directly observed treatment

Intervention Type: OTHER

Other Intervention Names

fixed-point delivery + non directly observed treatment; fixed-point delivery + directly observed treatment

Eligibility Criteria

Inclusion Criteria

Age >= 3 months & < 60 months

Exclusion Criteria

• severe, chronic illness
• known allergy to one of the study drugs (SP or AQ)
• known HIV positive subjects using Cotrimoxazole.

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

Sponsors

University of Bamako

OTHER

Sponsor Role: lead

Responsible Party

Alassane Dicko

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Malaria Research and Training Center

Bamako, , Mali

Site Status: RECRUITING

Countries

Mali

Central Contacts

Alassane Dicko, MD

Role: CONTACT

adicko@icermali.org

Amadou Barry, MD

Role: CONTACT

abarry@icermali.org

References

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.

Reference Type: DERIVED

PMID: 32126989 (View on PubMed)

Barry 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.

Reference Type: DERIVED

PMID: 29505578 (View on PubMed)

Other Identifiers

2014-61

Identifier Type: -

Identifier Source: org_study_id