Skip to main content
OpenTrials
Completed

NCT Number: NCT05085340

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 week–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundaçao Manhiça, Manhiça, Mozambique

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)

Drug

IPTi will be administered as full therapeutic courses of SP alongside routine EPI immunisations at defined intervals corresponding to vaccination schedules - usually at 10 weeks, 14 weeks, and 9 months of age - to infants living in project districts. Additional doses of IPTi will be administered at 6, 12, and 15 or 18 months of age, coinciding with vitamin A administration and measles booster immunisation. The number of doses of IPTi a child will receive will depend of the EPI schedule in the country, with a maximum of six doses in the first two years of life.

Other names: IPTi-SP

Primary outcomes

  1. Proportion of children having received at least three doses of IPTi

    Time frame: Month 24

Secondary outcomes

  1. Malaria prevalence in under 2 year old children living in project districts

    Time frame: Month 24

  2. Malaria incidence in under 2 year old children living in project districts

    Time frame: Month 24

  3. Coverage of EPI routine vaccines in children living in project districts

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

Barcelona Institute for Global Health

Other

Collaborators

  • Centro de Investigação em Saúde de Manhiça
  • Institut de Recherche pour le Developpement
  • Medicines for Malaria Venture
  • University of Lomé (UL), Togo
  • University of Sierra Leone

Registry information

Acronym: MULTIPLY

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 20, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.