# Focal mass drug administration (fMDA) to reduce Plasmodium vivax transmission, a pragmatic cluster randomized controlled trial in Peru

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $1,261,366

## Abstract

Project Summary/Abstract
In most countries approaching elimination, Plasmodium vivax (Pv) represents an increasing proportion relative
to P. falciparum (Pf). Mass drug administration (MDA), as a way target subpatent, asymptomatic infections, is
recommended for P. falciparum elimination, but the recommendation does not extend to P. vivax given limited
evidence, tools, and safety concerns. The objective of our study is to evaluate the long-term impact, safety,
and cost-effectiveness of focal MDA (fMDA) for Pv transmission reduction. To test our hypothesis that fMDA, in
addition to standard aggressive interventions, will safely reduce transmission, we propose a 3-year open-label
CRCT in the low endemic setting of Loreto Region, Peru. Villages or clusters will be randomized to control or
fMDA. The control arm will receive standard interventions (vector control, symptomatic case management, and
active case detection of asymptomatic cases). The treatment arm will receive standard interventions plus fMDA,
which will utilize a new drug for radical cure of P. vivax, tafenoquine, and a new quantitative glucose 6
phosphate dehydrogenase (G6PD) deficiency rapid test to support safe administration of tafenoquine. fMDA
will be targeted to consenting and eligible high-risk villagers, defined as household members and neighbors of
recent Pv index cases. fMDA will be conducted in 2 rounds per year, two months apart during the low malaria
season, and over 3 years. Eligibility will be re-assessed each year, and prior to each fMDA round. Specific
aims are to: 1) Determine the effectiveness of fMDA to reduce Pv transmission as measured in a primary
outcome of incidence and secondary outcomes of infection prevalence, seroprevalence, and genetic diversity,
2) Evaluate the safety and tolerability of fMDA, and 3) Measure the cost-effectiveness of fMDA. To maximize

## Key facts

- **NIH application ID:** 10680477
- **Project number:** 5U01AI157962-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Michelle Sang Hsiang
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,261,366
- **Award type:** 5
- **Project period:** 2022-08-10 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10680477

## Citation

> US National Institutes of Health, RePORTER application 10680477, Focal mass drug administration (fMDA) to reduce Plasmodium vivax transmission, a pragmatic cluster randomized controlled trial in Peru (5U01AI157962-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10680477. Licensed CC0.

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