Understanding and Maximizing the Community Impact of Antimalarial Treatment (INDIE-SMC)

NCT05878366 | Completed

• 2 other identifiers: 29193INV-053846
• Study Type: interventional
• Target: 2,978
• Locations: 1 country
• Sites: 1

Brief Summary

Seasonal Malaria Chemoprophylaxis (SMC) is a fundamental component of malaria control. The SMC program involves that sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Yet, its efficacy is increasingly below expectations. This study involves an Operational evaluation of a modified existing intervention and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs. The main questions it aims to answer are:

1. 1.what are the reasons for the continued high infection rates in the SMC-targeted population;
2. 2.what are the implications for transmission of sub-optimal SMC in children less than 5 years old;
3. 3.can the impact of SMC be improved by including older age groups that would both expand the population that experiences direct chemoprophylactic benefits and concurrently reduce transmission to the wider community

Conditions

Malaria; Malaria,Falciparum

Keywords

Plasmodium falciparum; Seasonal Malaria Chemoprevention; Antimalarial treatment; Burkina Faso; SP+AQ

Outcome Measures

Primary Outcomes (1)

• Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention.

  This endpoint will be compared between arms 1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 3 months-9 years).

  4 weeks

Secondary Outcomes (10)

• Parasite prevalence by microscopy at the end of the transmission season in all age groups

  4 weeks

• Parasite prevalence by qPCR at the end of the transmission season in all age groups

  4 weeks

• Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups

  8 weeks

• Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups

  10 weeks

• Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups

  10 weeks

Other Outcomes (5)

• Infectivity to mosquitoes, defined as the percentage of infected mosquitoes, in relation to gametocyte density and plasma drug levels of AQ and DESAQ

  Up to 10 weeks

• Size and age-distribution of the infectious reservoir for malaria

  Through study completion, an average of 10 months

• Prevalence of drug resistance markers in infected children aged 3 months-9 years assessed post each round of SMC (between arm comparison)

  Through study completion, an average of 10 months

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

SMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC

Other: Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT

Arm 2

EXPERIMENTAL

SMC in children under the age of 5 years, with directly observed treatment for the full course of SMC

Other: Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT

Arm 3

EXPERIMENTAL

SMC in children under the age of 10 years, with directly observed treatment for the full course of SMC

Other: Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT

Interventions

Seasonal Malaria Chemoprophylaxis (under 5 year old) implemented by the MoH without DOT OTHER

Standard approach for SMC strategy used by the Ministry of Health (without directly-observed therapy) and without any interference of the study team. Implemented over 4 rounds, carried out in June-October 2023 with \~30 days between rounds.

Arm 1

Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT OTHER

SMC will be implemented with the same number of rounds and the same timing as in active comparator arm but village health workers will visit the participants at home to administer each dose of study treatment (with DOT-directly-observed therapy)

Arm 2

Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT OTHER

SMC will be implemented as in arm 2 but age of participants is extended up to 10 years: each dose of study treatment (with DOT-directly-observed therapy) distributed at home by village health workers.

Arm 3

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for chemoprevention for SMC as per the current recommendations
• Age 3- 59 months for arms i. and ii.
• Age 60 months up to 10 years old for arm iii.
• Absence of symptomatic falciparum malaria, defined by fever on enrolment
• Absence of other non-P. falciparum species on blood film
• No evidence of acute severe or chronic disease
• Able and willing to comply with the study protocol and follow-up schedule
• Parent or guardian provides written, informed consent on behalf of child

You may not qualify if:

• Symptoms of malaria (axillary fever ≥ 37.5 °C and/or history of fever in the past 48 hours)
• Previous reaction to study drugs / known allergy to study drugs
• Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia \> 100,000 parasites / µL)
• Signs of acute or chronic illness, including hepatitis
• The use of other medication (except for paracetamol and/or aspirin)
• Presence of severe malnutrition according to WHO's child growth standards

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Groupe de Recherche Action en Sante: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

Location

Related Publications (1)

• Moreno M, Barry A, Gmeiner M, Yaro JB, Serme SS, Byrne I, Ramjith J, Ouedraogo A, Soulama I, Grignard L, Soremekun S, Koele S, Ter Heine R, Ouedraogo AZ, Sawadogo J, Sanogo E, Ouedraogo IN, Hien D, Sirima SB, Bradley J, Bousema T, Drakeley C, Tiono AB. Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial. BMJ Open. 2024 Mar 12;14(3):e081682. doi: 10.1136/bmjopen-2023-081682.

  PMID: 38479748 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Alfred Tiono, PhD, MD

  Groupe de Recherche Action en Sante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Laboratory analysis and impact analysis teams will be blinded to intervention arm. Entomology staff involved in the mosquito feeding assays will be blinded for the parasitology results.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study involves and Operational evaluation of a modified existing intervention delivered in independent clusters. The project and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 26, 2023
• Study Start: July 13, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 30, 2024
• Last Updated: July 4, 2025

Record last verified: 2024-01

Locations

BU (1)