Clinical trial NCT05856357: Perennial Malaria Chemoprevention (PMC) in Côte D'Ivoire
Official title: Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Côte D'Ivoire: the Plus Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malaria
Anemia
Keywords: Malaria
Anemia
Perennial malaria chemoprevention (PMC)
Intermittent preventative treatment of infants (IPTi)
Sulfadoxine-pyrimethamine (SP)
Chemoprevention
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Institut National de Santé Publique de Côte d'Ivoire
First posted: 2023-05-12
Enrollment: 1568
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children up to 6 months of age in Seguela and Kani health districts of Côte d'Ivoire.

Brief summary: The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 1568 children in the areas served by 19 health centres in Côte d'Ivoire. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.

Detailed description: Despite impressive progress in recent years, malaria continues to impose a heavy morbidity and mortality burden. Ninety-five percent of the estimated 247 million malaria cases and 619,000 deaths worldwide in 2021 occurred in the World Health Organization (WHO) Africa Region \[1\]. The expansion of SP-IPTi to include children up to two years of age and additional entry points, referred to now as PMC, offers the potential to increase the impact of the intervention by delivering more protective doses of SP to an age group with a higher malaria burden. However, to support the development of national policies and international guidelines on the adoption and implementation of PMC at scale, more evidence is needed on where, when, how and under what circumstances PMC can be effective, cost-effective, acceptable, equitable and feasible.

The aim of the impact evaluation is to inform decision-making by policy makers and programme managers involved in national malaria control programmes by evaluating the protective efficacy of PMC with five doses versus zero doses as standard of care in Côte d'Ivoire. The design is a multi-site quantitative study of the implementation of PMC in Côte d'Ivoire. The health districts of Seguela and Kani were identified as the intervention and control districts, respectively, based on population size, number of Extended Programme of Immunisation (EPI) facilities, malaria incidence, EPI coverage and availability of an appropriate control population receiving standard care.

All children up to 36 months of age with parental consent will be recruited into a passive cohort. The investigators will also extract data on malaria and anaemia cases among children receiving PMC from health facility records.

The investigators will form and follow an active arm of the cohort in which a randomly selected subset of children in the passive cohort will be visited every three months during the study period in their homes to obtain detailed information, including details of the household, malaria risk factors, history of malaria and anaemia, health-seeking behaviour, and past EPI vaccinations. Blood will be collected for microscopy measures of parasitaemia, anaemia diagnosis by haemoglobin levels, and retrospective analysis of malaria infection (not for clinical management) by polymerase chain reaction methods. Rapid diagnostic tests will be used amongst symptomatic children to identify cases. First line antimalarial treatment will be provided to all confirmed cases. Children will be screened for malnutrition by measuring their mid-upper arm circumference (MUAC). If they are determined to have either moderate (MAM) or severe acute malnutrition (SAM), treatment will consist of standard of care which can include referral to the nearest health facility with clinical management capacity or treatment on site.

Eligibility criteria: Inclusion Criteria:

* Reside in Seguela (intervention) or Kani (control) health districts.
* Agree to take part in the census.
* Aged 10 weeks to six months at the time of enrolment.
* Parent/caregiver informed consent obtained.

Exclusion Criteria:

* Parent/caregiver refused to participate in the cohort.
* Parent/caregiver did not give informed consent.

Primary outcomes:
measure: Incidence of malaria infection and clinical malaria
timeFrame: 18 months
Secondary outcomes:
measure: Incidence of severe malaria, malaria deaths, anaemia and severe anaemia
timeFrame: 18 months
measure: Malaria and anaemia incidence by delivery platform, number of doses and dose schedule
timeFrame: 18 months
measure: Dose-response effects of SP on malaria and anaemia
timeFrame: 18 months
measure: Effects of distance to health facility on malaria and anaemia
timeFrame: 18 months
measure: Incidence of moderate, severe and overall malnutrition
timeFrame: 12 months
Other outcomes:
Locations:
city: Séguéla
country: Côte D'Ivoire
facility: Multiple
Study officials:
affiliation: Institut National de Santé Publique de Côte d'Ivoire
name: William Yavo, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: R Matthew Chico, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: WHO Malaria Report 2022, World Health Organisation