MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

NCT05085340 | Completed

• 1 other identifier: RIA2020S 3272
• Study Type: observational
• Target: 94,252
• Locations: 3 countries
• Sites: 3

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.

Conditions

Malaria

Keywords

IPTi; Sulfadoxine-pyrimethamine; IPTi-SP; chemoprevention; Intermittent preventive treatment of malaria in infants; children; EPI; Expanded Programme of Immunization; SSA; sub-Saharan Africa; infants; malaria

Outcome Measures

Primary Outcomes (1)

• Proportion of children having received at least three doses of IPTi

  Month 24

Secondary Outcomes (3)

• 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

Interventions

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.

Also known as: IPTi-SP

Eligibility Criteria

• Age: 10 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead
• Institut de Recherche pour le Developpement: collaborator
• Centro de Investigação em Saúde de Manhiça: collaborator
• Medicines for Malaria Venture: collaborator
• University of Lomé (UL), Togo: collaborator
• University of Sierra Leone: collaborator

Study Sites (3)

Fundaçao Manhiça

Manhiça, Manhiça, Mozambique

Location

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

Freetown, Sierra Leone

Location

University of Lomé

Lomé, Togo

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Clara Menéndez, MD, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: February 14, 2022
• Primary Completion: December 31, 2024
• Study Completion: October 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); TO (1); SI (1)