MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention (MULTIPLY)

As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on Immunization (EPI), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. PMC is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, SP) delivered to infants in the context of routine immunisation services during the first two year of life.

PMC has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the World Health Organization (WHO) recommended in 2010 Intermittent Preventive Treatment for Infants (IPTi) for malaria prevention. Only one African country - Sierra Leone -put IPTi into policy and practice. Concerned with this slow adoption, WHO in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. In 2022, WHO expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. The name for this preventive treatment has consequently changed to Perennial Malaria Chemoprevention (PMC) as the updated recommendation is no longer just for infants.

MULTIPLY is the pilot implementation of PMC in selected districts in Mozambique, Sierra Leone and Togo to maximise the delivery and uptake of PMC, to achieve the full potential of this intervention. Working with the ministries of health in Mozambique, Sierra Leone and Togo, MULTIPLY will give up to 6 doses of PMC in the first two years of life. PMC will be given at health facilities and EPI mobile outreach clinics using a paediatric dispersible formulation of SP, alongside routine vaccinations and vitamin A supplementation.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Drug: Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)

Detailed Description

The study will be conducted in 3 sub-Saharan African countries; Sierra Leone, Mozambique and Togo.

Sample size; Assuming an average population of a district/project area of 150,000 inhabitants and a percentage of U2 children of 5%, the project intervention will target approximately 45,000 U2 children in total (i.e. 7,500 children per country and per year for 2 years).

Study population; Children U2 who are eligible for IPTi in the selected MULTIPLY district of each country.

• Study Type: Observational
• Enrollment (Actual): 94252

Contacts and Locations

Study Locations

• Mozambique
  • Manhiça
    • Manhiça, Manhiça, Mozambique
      • Fundaçao Manhiça
• Sierra Leone
  • Freetown, Sierra Leone
    • College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone
• Togo
  • Lomé, Togo
    • University of Lomé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Description

Inclusion Criteria:

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Exclusion Criteria:

Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of children having received at least three doses of IPTi	Month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Malaria prevalence in under 2 year old children living in project districts	Month 24
Malaria incidence in under 2 year old children living in project districts	Month 24
Coverage of EPI routine vaccines in children living in project districts	Month 24

Collaborators and Investigators

• Sponsor: Barcelona Institute for Global Health
• Collaborators: Centro de Investigacao em Saude de Manhica; Medicines for Malaria Venture; University of Sierra Leone; Institut de Recherche pour le Developpement; University of Lomé (UL), Togo
• Investigators: Principal Investigator: Clara Menendez, MD, PhD, Barcelona Institute for Global Health

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: children; infants; malaria; sub-Saharan Africa; Sulfadoxine-pyrimethamine; IPTi; chemoprevention; EPI; IPTi-SP; Intermittent preventive treatment of malaria in infants; Expanded Programme of Immunization; SSA
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents, Urinary; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
• Other Study ID Numbers: RIA2020S 3272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No