Actively Recruiting

Phase 3
All Genders
Healthy Volunteers
ID05690841

FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru

Led by University of California, San Francisco · Updated on 2025-11-14

7530

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

Universidad Peruana Cayetano Heredia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department of Peru, a low transmission area. This open-label cluster-randomized controlled trial compares standard malaria control measures with additional fMDA targeting high-risk villagers near recent malaria cases. The study also aims to assess the safety, tolerability, cost-effectiveness, and acceptance of fMDA in this population. The trial involves two study groups: a control group receiving standard interventions such as insecticide-treated bednets, mosquito breeding site management, and malaria case detection and treatment, and an experimental group receiving these standard interventions plus fMDA. The fMDA intervention is administered in two rounds per cycle, with three cycles over the study period. Treatments include chloroquine (CQ), tafenoquine (TQ), and primaquine (PQ) given according to age and eligibility, with dosing schedules designed to treat blood and liver stages of malaria and provide prophylactic effects. Participants will be involved in surveys and blood sample collections at baseline, interim, and endline points over the three-year intervention period. Fever cases are monitored and treated per national guidelines. Researchers will measure cumulative incidence of malaria infections, genetic diversity, drug tolerability and adherence, refusal rates, and cost metrics. The trial is implemented pragmatically through the existing health system, with continued monitoring for safety and public health impact throughout the study duration.

CONDITIONS

Brief Title

FocaL Mass Drug Administration for Vivax Malaria Elimination

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Village clusters must be within 8 hours transport of Iquitos
  • Village incidence of malaria less than 250 cases per 1000 and more than 2 cases in the year before the trial
  • Village population size less than 650
  • Reside in a household within 200 meters of a Plasmodium vivax index case in the past 2 years
  • Age 6 months or older
  • Present in the village for the intervention
  • Adults 18 years or older must provide informed consent
  • Children 8 to under 18 years old must provide assent and have parental consent
  • Children 6 months to under 8 years old must have parental consent
  • Villagers who slept in a household in the cluster for at least one night in the past four weeks are eligible for surveys
  • High-risk villagers near recent malaria cases are eligible for fMDA during each cycle
Not Eligible

You will not qualify if you...

  • History of retinal or visual field changes
  • Known allergy or adverse reaction to chloroquine, tafenoquine, or primaquine
  • Taking chloroquine currently or within the past four weeks
  • Hemoglobin level below 9 g/dL
  • G6PD deficiency or intermediate enzyme activity below defined thresholds
  • Unknown or refused G6PD testing
  • Acute or severe malaria
  • Pregnancy or refusal of pregnancy test if recent missed periods
  • Breastfeeding a child with G6PD deficiency or unknown status
  • Taken mefloquine, tafenoquine, primaquine, or other antimalarials in the past four weeks

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 years

Participants in the fMDA group receive focal mass drug administration targeting high-risk individuals living near recent malaria cases. Each cycle includes two rounds of medication: the first round involves 3 days of chloroquine plus tafenoquine or primaquine depending on age and G6PD status, followed by a second round with single-dose chloroquine plus tafenoquine or primaquine. This cycle is repeated for 3 cycles spaced apart by regular intervals over the trial period.

6 rounds of drug administration (2 rounds per cycle, 3 cycles), each round involving multiple days of medication with directly observed therapy

Surveillance

Duration - Throughout the 3-year trial and at endline in year 4

Participants are monitored through interim and endline surveys that include dried blood spot collection and fever screening to assess malaria infection and transmission.

1 interim survey and 1 endline survey

Trial Site Locations

Total: 1 location

1

Asociación Civil Selva Amazónica

Iquitos, Peru

Actively Recruiting

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Research Team

S

Sydney Fine, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effectiveness of reactive focal mass drug administration and reactive focal vector control to reduce malaria transmission in the low malaria-endemic setting of Namibia: a cluster-randomised controlled, open-label, two-by-two factorial design trial.

Michelle S Hsiang, Henry Ntuku, Kathryn W Roberts...

https://pubmed.ncbi.nlm.nih.gov/32334702

Cost and cost effectiveness of reactive case detection (RACD), reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) to reduce malaria in the low endemic setting of Namibia: an analysis alongside a 2×2 factorial design cluster randomised controlled trial.

Henry Ntuku, Cara Smith-Gueye, Valerie Scott...

https://pubmed.ncbi.nlm.nih.gov/35738650

Mass drug administration for the control and elimination of Plasmodium vivax malaria: an ecological study from Jiangsu province, China.

Michelle S Hsiang, Jimee Hwang, Amy R Tao...

https://pubmed.ncbi.nlm.nih.gov/24175930

FocaL mass drug administration for Plasmodium vivax malaria elimination (FLAME): study protocol for an open-label cluster randomized controlled trial in Peru.

Sydney R Fine, Veronica Soto Calle, Astrid Altamirano Quiroz...

https://pubmed.ncbi.nlm.nih.gov/41088393

FocaL mass drug Administration for Plasmodium vivax Malaria Elimination (FLAME): study protocol for an open-label cluster randomized controlled trial in Peru.

Sydney Fine, Astrid Altamirano Quiroz, Veronica Soto Calle...

https://pubmed.ncbi.nlm.nih.gov/40321759