Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Type Two Hybrid Implementation Study

NCT05186363 | Unknown Phase 4 DMC

• 2 other identifiers: SMCMOZPHASE2INV-033337
• Study Type: interventional
• Target: 3,156
• Locations: 1 country
• Sites: 2

Brief Summary

We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.

Conditions

Malaria

Keywords

seasonal malaria chemoprevention

Outcome Measures

Primary Outcomes (3)

• Malaria Incidence

  RDT confirmed malaria cases in enrolled populations as reported through passive surveillance

  Four months

• Chemopreventive Efficacy

  chemoprevention failure in the presence of adequate drug concentration

  One month

• Prevalence of resistance markers

  Prevalence of relevant sulfadoxine-pyrimethamine (SP) or amodiaquine (AQ) or piperiquine associated antimalarial resistance markers

  Five months

Secondary Outcomes (3)

• Severe anemia

  Five months

• Severe anemia levels

  Five months

• Parestemia levels

  Five months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

SMC eligible kids aged 3-59 months who will receive a standard SMC intervention of 4 cycles of SPAQ over 4 months.

Drug: Chemopreventive Agent - SPAQ

Control

ACTIVE COMPARATOR

SMC eligible kids aged 3-59 months who will not receive a standard SMC intervention of 4 cycles of SPAQ over 4 months.

Drug: Control Test - no drugs given

Interventions

Chemopreventive Agent - SPAQ DRUG

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections in areas where the malaria burden is high and transmission occurs mainly during the rainy season. It involves administering monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) during this peak transmission period to those most at risk: children 3-59 months.

Also known as: sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ)

Intervention

Control Test - no drugs given DRUG

This is where children aged 3-59 months do not receive any chemoprevention drugs but do receive health promotion messages and visit from health workers similar to the chemoprevention SPAQ arm.

Also known as: Control - no drugs given

Control

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-59 months living in a SMC eligible area in Lalua or Mercate district in Nampula province in Mozambique.

You may not qualify if:

• Children with HIV,
• Children with a history of severe adverse reaction to SP or AQ, or
• children who had used SP within the previous month before recruitment

Sponsors & Collaborators

• Malaria Consortium: lead

Study Sites (2)

Lalaua district

Nampula, Mozambique

Location

Muecate District

Nampula, Mozambique

Location

Related Publications (1)

• Baker K, Aide P, Bonnington CA, Rassi C, Richardson S, Roca-Feltrer A, Rodrigues M, Sitoe M, Pulido Tarquino IA, Enosse S, McGugan C, de Carvalho EA, Saute F, Mayor Aparicio AG, Candrinho B. Feasibility, Acceptability, and Protective Efficacy of Seasonal Malaria Chemoprevention Implementation in Nampula Province, Mozambique: Protocol for a Hybrid Effectiveness-Implementation Study. JMIR Res Protoc. 2022 Sep 23;11(9):e36403. doi: 10.2196/36403.

  PMID: 36149743 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Amodiaquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Baltazar Candrinho, MD

  National Malaria Control Programme, Ministry of Health Mozambique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: January 11, 2022
• Study Start: January 8, 2022
• Primary Completion: June 21, 2022
• Study Completion: December 1, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

MO (2)