MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

NCT ID: NCT05085340

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94252 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2025-10-31

Brief Summary

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.

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.

Conditions

Malaria

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

IPTi-SP

Eligibility Criteria

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

• Minimum Eligible Age: 10 Weeks
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role: collaborator

Centro de Investigação em Saúde de Manhiça

OTHER

Sponsor Role: collaborator

Medicines for Malaria Venture

OTHER

Sponsor Role: collaborator

University of Lomé (UL), Togo

UNKNOWN

Sponsor Role: collaborator

University of Sierra Leone

OTHER

Sponsor Role: collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clara Menéndez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barcelona Institute for Global Health

Locations

Fundaçao Manhiça

Manhiça, Manhiça, Mozambique

College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone

Freetown, , Sierra Leone

University of Lomé

Lomé, , Togo

Countries

Mozambique; Sierra Leone; Togo

Other Identifiers

RIA2020S 3272

Identifier Type: -

Identifier Source: org_study_id