Focal mass drug administration to eliminate Vivax malaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of focal mass drug administration (fMDA) in reducing Plasmodium vivax malaria incidence in the Loreto Department of Peru. It is an open-label cluster-randomized controlled trial where villages are randomized to receive either fMDA or standard interventions, including screening and vector control. The fMDA will target high-risk individuals living near previous malaria cases, administering chloroquine and tafenoquine over multiple cycles. The study aims to assess the impact of these interventions on malaria transmission in a low-incidence setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cluster eligibility

   * Within 8 hours transport of Iquitos
   * Incidence \<250/1000 and \>2 cases year prior to trial
   * Population size (\<650)
2. 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
3. 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
4. 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
5. 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
6. 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 Criteria:

1. 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
2. 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
3. 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
   * Woman breastfeeding a 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

Where it's running

• Asociación Civil Selva Amazónica
  Iquitos, Peru Recruiting

Study contacts

• Principal investigator: Michelle Hsiang, MD — University of California, San Francisco
• Study coordinator: Sydney Fine, MPH
• Email: sydney.fine@ucsf.edu
• Phone: 415-476-5494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.