FocaL Mass Drug Administration for Vivax Malaria Elimination
FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru
University of California, San Francisco
7,530 participants
Oct 14, 2024
INTERVENTIONAL
Conditions
Summary
FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.
Eligibility
Inclusion Criteria27
- Cluster eligibility
- Within 8 hours transport of Iquitos
- Incidence \<250/1000 and \>2 cases year prior to trial
- Population size (\<650)
- Chloroquine (CQ) eligibility
- Resides in neighboring household but within 200 m of Pv index case in the past 2 years
- Age ≥6 months old
- Present for intervention
- Adult ≥18 years old that provides informed consent
- A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents
- A child ≥6 months old and \<8 years old that has informed consent from their parents
- Tafenoquine (TQ) eligibility
- Eligible to receive CQ
- Age ≥16 years old
- Adult ≥18 years old that provides informed consent
- A child ≥16 years and \<18 years old that provides informed assent and has informed consent from their parents
- Primaquine eligibility
- Eligible to receive CQ and ineligible to receive TQ
- Age ≥6 months old
- Adult ≥18 years old that provides informed consent
- A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents
- A child ≥6 months old and \<8 years old that has informed consent from their parents
- Baseline evaluation and informed consent
- Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks
- Eligibility for fMDA
- High-risk villagers are defined as individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household) will be eligible to receive fMDA that cycle
- Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle.
Exclusion Criteria26
- Chloroquine eligibility
- History of retinal or visual field changes
- Known hypersensitivity or adverse reaction to CQ
- Currently taking CQ or have taken CQ in the past four weeks
- Ineligible for TQ or PQ (see criteria below)
- Hemoglobin \<9 g/dL
- Tafenoquine eligibility
- G6PD deficiency or intermediate status (defined as activity ≤6.0 UI/gHb per SD biosensor)
- G6PD status unknown or refusal of G6PD status test
- Acute or severe malaria
- Pregnancy (known or identified by pregnancy test)
- Refusal of pregnancy test if new amenorrhea in the past 4 weeks
- Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status
- Known hypersensitivity or adverse reaction to TQ or PQ
- Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks
- Hemoglobin \< 9 g/dL
- Primaquine eligibility
- G6PD deficiency (defined as activity ≤4.0 UI/gHb per SD biosensor)
- G6PD status unknown or refusal of G6PD status test
- Acute or severe malaria
- Pregnancy (known or identified by pregnancy test)
- Refusal of pregnancy test if new amenorrhea in the past 4 weeks
- Breastfeeding child with documented or unknown G6PD deficiency status
- Known hypersensitivity or adverse reaction to TQ or PQ
- Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks
- Hemoglobin \< 9 g/dL
Interventions
Administration of focal mass drug administration for high-risk individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household). Intervention to be administered two times, two months apart each cycle, for 3 cycles spaced apart by regular intervals. Each year will include 2 rounds of fMDA. Round 1) Chloroquine (CQ)+ Tafenoquine (TQ) for \>= 16y (CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg CQ, TQ 300 mg on Day 1); CQ+ Primaquine (PQ) for \<16y (CQ: age-based dosing, PQ age-based dosing); CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg, PQ age-based dosing). Round 2) single dose CQ+TQ for \>= 16y (CQ: Day1 600 mg, TQ 300 mg on Day 1); single dose CQ+PQ for \<16y (CQ: age-based dosing, PQ age-based dosing); single dose CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, PQ age-based dosing).
Locations(1)
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For the most up-to-date information, visit the official listing.
NCT05690841