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

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. what are the reasons for the continued high infection rates in the SMC-targeted population;
2. what are the implications for transmission of sub-optimal SMC in children less than 5 years old;
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

Researchers will:

i) Compare SMC effectiveness as implemented by the national malaria control program and SMC implemented in a research context where all doses are directly observed.

ii) Quantify the infectious reservoir and the contribution of different age groups to transmission with conventional SMC (\<5 years) and extended SMC (\<10 years) iii) Determine the impact of drug resistance and drug absorption on SMC efficacy iv) Understand social barriers and enablers interfering with SMC efficacy and how SMC uptake is related to health equity with special attention to gender inequalities.

v) Quantify SMC efficacy decay under programmatic conditions and key drivers of this decay.

Conditions

• Malaria
• Malaria,Falciparum

Interventions

OTHER

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

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.

OTHER

Seasonal Malaria Chemoprophylaxis (under 5 years old) with DOT

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)

OTHER

Seasonal Malaria Chemoprophylaxis (under 10 years old) with DOT

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.

Sponsors & Collaborators

• Groupe de Recherche Action en Sante

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Alfred Tiono, PhD, MD · Groupe de Recherche Action en Sante

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-13

Primary Completion

2024-01-15

Completion

2024-03-30

Countries

• Burkina Faso

Study Locations